xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06036862</url>
    </required_header>
    <id_info>
      <org_study_id>GIHSYSU-TLCAS</org_study_id>
      <nct_id>NCT06036862</nct_id>
    </id_info>
    <brief_title>Utilization of Transanal Endoscopy in the Treatment of Anastomotic Stenosis</brief_title>
    <official_title>A Prospective Clinical Study of Transanal and Transabdominal Combined Endoscopic Resection of Rectal Stenosis and Anal Reconstruction for Severe Rectal Anastomotic Stenosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Severe rectal anastomotic stenosis can not only cause intestinal obstruction, but also be&#xD;
        accompanied by frequent defecation, which affects the quality of life, and patients face the&#xD;
        outcome of permanent stoma or temporary stoma again. Traditional transabdominal resection and&#xD;
        reconstruction of rectal anastomotic stenosis is more likely to occur due to unclear&#xD;
        anatomical structure, dense scars around the intestinal canal, complications such as ureteral&#xD;
        and urethral injury and massive presacral hemorrhage. In addition,41%of patients with&#xD;
        anastomotic stenosis who underwent reoperation through abdominal surgery had anastomotic&#xD;
        leakage again, and up to 30% of patients could not close the stoma. The advantages of&#xD;
        transanal total mesorectal excision (taTME) using a transanal approach for total mesorectal&#xD;
        excision in the treatment of middle and low rectal cancer with difficult pelvis have been&#xD;
        demonstrated by our group. However, taTME has rarely been explored in the treatment of&#xD;
        anastomotic stenosis. Our team retrospectively summarized the patients who underwent&#xD;
        transabdominal transanal endoscopic resection and reconstruction of anastomotic stenosis&#xD;
        (l-taTME), and initially demonstrated the safety and effectiveness of this surgical method,&#xD;
        with a stoma closure rate of 90%. Although the advantages of l-taTME in the treatment of&#xD;
        severe rectal anastomotic stenosis are obvious in theory and preliminary clinical practice,&#xD;
        there is a lack of prospective studies. Therefore, the investigators plan to conduct a&#xD;
        prospective clinical study to observe the safety and efficacy of l-taTME reconstruction&#xD;
        surgery, and to provide high-level evidence-based medical basis for the selection of&#xD;
        resection and reconstruction surgery for patients with rectal anastomotic stenosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Colorectal cancer is the most common malignant tumor of the digestive tract. At present,&#xD;
        surgery is still the main treatment for rectal cancer. Although stapler anastomosis improves&#xD;
        the safety of surgical resection and reconstruction for middle and low rectal cancer,&#xD;
        surgical complications, especially anastomotic leakage, are inevitable, especially for middle&#xD;
        and low rectal cancer, where the incidence of anastomotic leakage reaches 8-11%. The outcome&#xD;
        of anastomotic leakage will lead to anastomotic stenosis, especially in middle and low rectal&#xD;
        cancer after neoadjuvant radiotherapy, and the incidence of anastomotic stenosis is as high&#xD;
        as 3%-10%. Previous studies have suggested that anastomotic diameter &lt; 20mm is considered as&#xD;
        an anastomotic stenosis, and it has also been shown that an anastomotic diameter less than&#xD;
        1/3 of the original diameter of the intestinal lumen is considered as an anastomotic&#xD;
        stenosis. Anastomotic stenosis can not only cause intestinal obstruction symptoms, such as&#xD;
        abdominal distension and abdominal pain, but also be accompanied by frequent defecation,&#xD;
        which affects the quality of life, and many patients face the outcome of permanent stoma or&#xD;
        temporary stoma again.&#xD;
  &#xD;
        Anastomotic stenosis is divided into membranous stenosis and tubular stenosis according to&#xD;
        the degree of stenosis. For anastomotic membranous stenosis, endoscopic incision of the&#xD;
        stenosis ring or balloon dilatation is the preferred method for the treatment of membranous&#xD;
        stenosis. However, endoscopic scar incision and balloon dilation require repeated, multiple&#xD;
        treatments to achieve long-term effectiveness, with the risk of perforation, pelvic&#xD;
        infection, and bleeding. Balloon dilatation or scar incision has little effect on patients&#xD;
        with low anastomosis position or tubular stenosis, and nearly 30% of patients need to undergo&#xD;
        resection and reconstruction of the stenotic anastomosis. As anastomotic stenosis is often&#xD;
        caused by anastomotic leakage, anastomotic ischemia, radiotherapy and chemotherapy, use of&#xD;
        stapler, pelvic infection and low anastomosis, the anatomical structure is unclear, the scar&#xD;
        around the bowel is dense, and complications such as ureteral and urethral injury and massive&#xD;
        bleeding of presacral veins are more likely to occur during the resection and reconstruction&#xD;
        of the stricture. Lefevre et al. reported 33 patients who underwent resection and&#xD;
        reconstruction of transabdominal rectal anastomotic stenosis, and the incidence of&#xD;
        perioperative complications was 54.5%, including anastomotic leakage of 18%（6/33） and&#xD;
        postoperative intestinal obstruction of 12%. Genser et al. reported 50 patients with surgical&#xD;
        treatment of anastomotic stenosis, of whom 12（24%） received intraoperative blood transfusion,&#xD;
        with an average blood transfusion volume of 2.5 units. The incidence of intraoperative&#xD;
        complications was 12%, including 5 cases of bladder injury and 1 case of splenectomy due to&#xD;
        splenic injury due to unclear anatomical location. Westerduin et al. summarized 59 patients&#xD;
        who underwent secondary surgery for anastomotic leakage and stenosis, and 41% of them had&#xD;
        recurrent anastomotic leakage 14 months after surgery. During the follow-up of 27 months,&#xD;
        only 66% of the patients regained intestinal continuity,24%of the patients received permanent&#xD;
        colostomy, and 10% of the patients retained ileostomy.&#xD;
  &#xD;
        Due to the difficulty of surgery, it is difficult to remove the scar tissue around the&#xD;
        anastomosis in the traditional abdominal resection and reconstruction surgery. The new&#xD;
        rectorectum cannot be pulled out and anastomosed with the distal rectoanal canal again. After&#xD;
        reluctant anastomosis, the incidence of anastomotic leakage is still high due to the high&#xD;
        tension of rectorectum, and many patients have to accept permanent stoma. Transanal total&#xD;
        mesorectal excision (taTME), which uses a transanal approach to perform total mesorectal&#xD;
        excision, has been demonstrated by our team for the surgical treatment of middle and low&#xD;
        rectal cancer with difficult pelvis. However, the use of taTME in the treatment of&#xD;
        anastomotic stenosis is rarely explored at present. Our team first reported this surgical&#xD;
        method in 2021. The investigators retrospectively summarized 17 patients who underwent&#xD;
        resection and reconstruction of anastomotic stenosis by transabdominal transanal endoscopic&#xD;
        surgery. The ileostomy or colostomy was closed in 15 patients, which proved the safety and&#xD;
        effectiveness of this surgical method. Transabdominal transanal endoscopic resection and&#xD;
        reconstruction surgery has obvious advantages in the treatment of patients with rectal&#xD;
        anastomotic stenosis. First, it can accurately separate the narrow distal intestine, and&#xD;
        transanal anastomosis of the substitute rectum and the distal rectoanal canal can be&#xD;
        performed, which reduces the difficulty of reconstruction. Secondly, from the distal normal&#xD;
        anorectal canal, it can enter the normal anatomical structure space, and the narrow scar&#xD;
        segment can be completely resected by endoscopic magnification. At the same time, it can&#xD;
        reduce the accidental injury of the surrounding normal tissue and significantly reduce the&#xD;
        incidence of intraoperative complications. Finally, the mobilization of the left hemicolon&#xD;
        and splenic flexure of the abdomen was completed laparoscopically, and the specimen was&#xD;
        removed through the anus, which did not require additional abdominal incision and thus&#xD;
        reduced trauma. Although the advantages of transanal transabdominal combined with&#xD;
        laparoscopic resection and reconstruction in the treatment of severe rectal anastomotic&#xD;
        stenosis are very obvious in theory and preliminary clinical practice, there is a lack of&#xD;
        prospective studies.&#xD;
  &#xD;
        For the above reasons, the investigators plan to conduct a prospective clinical study to&#xD;
        observe the safety and efficacy of transanal laparoscopic resection and reconstruction in&#xD;
        patients with rectal anastomotic stenosis, in order to improve the quality of life of&#xD;
        patients with rectal anastomotic stenosis, and to provide high-level evidence-based medical&#xD;
        basis for the selection of resection and reconstruction surgery for patients with rectal&#xD;
        anastomotic stenosis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Stoma recovery rate</measure>
      <time_frame>3 months after surgery</time_frame>
      <description>whether the stoma recovery and restoration of bowel continuation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>incidence of postoperative anastomotic leakage</measure>
      <time_frame>1 month after surgery</time_frame>
      <description>whether the occurence of anastomotic leakage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of postoperative anastomotic bleeding</measure>
      <time_frame>Duration of 7 days after surgery</time_frame>
      <description>whether the occurence of anastomotic bleeding</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of severe bowel dysfunction</measure>
      <time_frame>3 months after stoma recovery</time_frame>
      <description>Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of severe bowel dysfunction</measure>
      <time_frame>6 months after stoma recovery</time_frame>
      <description>Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of severe bowel dysfunction</measure>
      <time_frame>1 year after stoma recovery</time_frame>
      <description>Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of severe bowel dysfunction</measure>
      <time_frame>2 years after stoma recovery</time_frame>
      <description>Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anorectal function</measure>
      <time_frame>1 year after stoma recovery</time_frame>
      <description>Anorectal pressure Rectal sensory function Rectoanal reflex function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anorectal function</measure>
      <time_frame>2 year after stoma recovery</time_frame>
      <description>Anorectal pressure Rectal sensory function Rectoanal reflex function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>bowel function</measure>
      <time_frame>3 months after stoma recovery</time_frame>
      <description>Memorial Sloan-Kettering Cancer Center bowel function instrument</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>bowel function</measure>
      <time_frame>6 months after stoma recovery</time_frame>
      <description>Memorial Sloan-Kettering Cancer Center bowel function instrument</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>bowel function</measure>
      <time_frame>1 year after stoma recovery</time_frame>
      <description>Memorial Sloan-Kettering Cancer Center bowel function instrument</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>bowel function</measure>
      <time_frame>2 year after stoma recovery</time_frame>
      <description>Memorial Sloan-Kettering Cancer Center bowel function instrument</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life evaluation after stoma closure</measure>
      <time_frame>3 months</time_frame>
      <description>European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0：poor 100:best)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life evaluation after stoma closure</measure>
      <time_frame>6 months</time_frame>
      <description>European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0：poor 100:best)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life evaluation after stoma closure</measure>
      <time_frame>1 year</time_frame>
      <description>European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0：poor 100:best)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life evaluation after stoma closure</measure>
      <time_frame>2 years</time_frame>
      <description>European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0：poor 100:best)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life evaluation after stoma closure</measure>
      <time_frame>3 years</time_frame>
      <description>European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0：poor 100:best)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inraoperative condition</measure>
      <time_frame>In the process of operation</time_frame>
      <description>operation time and whether to convert to laparotomy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perioperative recovery time</measure>
      <time_frame>perioperative period</time_frame>
      <description>Duration of analgesics in hours For the first time the exhaust time in hours Time to first defecation in hours Time to first fluid intake in hours Time to resume normal diet in hours Abdominal drainage tube removal time in days Catheter removal time in days Length of postoperative hospital stay in days</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Anastomotic Stenosis</condition>
    <arm_group>
      <arm_group_label>Patients with severe rectal anastomotic stenosis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Focusing on Patients with severe rectal anastomotic stenosis, espically long length and ultra lower firbrotic stenosis</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstruction</intervention_name>
      <description>Laparoscopic or open surgery was selected according to the patient's condition, surgical history and surgeon's experience.According to the extent of the rectal stenosis, the proximal colon was dissected.A circular incision was made above the dentate line and the broken end was sutured. After the intestinal cavity was closed, a single port was inserted through the anus, and a transanal endoscopic platform was established after pneumoperitoneum infusion.The stenotic and scar segments were removed free upward.Through the pelvic cavity and into the abdominal cavity from the bottom up. The narrow rectum and proximal colon were pulled out of the anus through the anus, and the diseased bowel was removed. According to the distance of the remaining distal rectum, stapler or manual anastomosis or Bacon operation was selected.</description>
      <arm_group_label>Patients with severe rectal anastomotic stenosis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age of 18-70 years old;&#xD;
  &#xD;
            2. ECOG performance status score 0-2;&#xD;
  &#xD;
            3. previous rectal resection;&#xD;
  &#xD;
            4. patients diagnosed with middle and low rectal anastomotic tubular stenosis;&#xD;
  &#xD;
            5. can tolerate general anesthesia;&#xD;
  &#xD;
            6. The subjects and their family members, who could understand the study protocol and&#xD;
               were willing to participate, signed the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patients with acute intestinal obstruction, intestinal perforation or intestinal&#xD;
               bleeding requiring emergency surgery;&#xD;
  &#xD;
            2. severe pelvic adhesion and frozen pelvis;&#xD;
  &#xD;
            3. patients with unstable primary tumors or combined with tumors at other sites;&#xD;
  &#xD;
            4. previous history of left hemicolectomy;&#xD;
  &#xD;
            5. ASA grade IV to V;&#xD;
  &#xD;
            6. combined organ resection;&#xD;
  &#xD;
            7. severe mental illness;&#xD;
  &#xD;
            8. pregnant or lactating women;&#xD;
  &#xD;
            9. severe cardiovascular disease, uncontrolled infection or other uncontrolled&#xD;
               comorbidities;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yanhong Deng, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Liang Huang, Doctor</last_name>
      <phone>15989101216</phone>
      <email>huangl75@mail.sysu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sixth Affiliated Hospital of Sun yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Liang Huang, Doctor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
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      <citation>Liu H, Zeng Z, Zhang H, Wu M, Ma D, Wang Q, Xie M, Xu Q, Ouyang J, Xiao Y, Song Y, Feng B, Xu Q, Wang Y, Zhang Y, Hao Y, Luo S, Zhang X, Yang Z, Peng J, Wu X, Ren D, Huang M, Lan P, Tong W, Ren M, Wang J, Kang L; Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group. Morbidity, Mortality, and Pathologic Outcomes of Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer Short-term Outcomes From a Multicenter Randomized Controlled Trial. Ann Surg. 2023 Jan 1;277(1):1-6. doi: 10.1097/SLA.0000000000005523. Epub 2022 Jul 11.</citation>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Yanhong Deng</investigator_full_name>
      <investigator_title>Principal investigator of the sixth affiliated hospital of Sun Yat-sen University</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Constriction, Pathologic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06036862
  org study id: GIHSYSU-TLCAS
  nct id: NCT06036862
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Severe rectal anastomotic stenosis can not only cause intestinal obstruction, but also be
        accompanied by frequent defecation, which affects the quality of life, and patients face the
        outcome of permanent stoma or temporary stoma again. Traditional transabdominal resection and
        reconstruction of rectal anastomotic stenosis is more likely to occur due to unclear
        anatomical structure, dense scars around the intestinal canal, complications such as ureteral
        and urethral injury and massive presacral hemorrhage. In addition,41%of patients with
        anastomotic stenosis who underwent reoperation through abdominal surgery had anastomotic
        leakage again, and up to 30% of patients could not close the stoma. The advantages of
        transanal total mesorectal excision (taTME) using a transanal approach for total mesorectal
        excision in the treatment of middle and low rectal cancer with difficult pelvis have been
        demonstrated by our group. However, taTME has rarely been explored in the treatment of
        anastomotic stenosis. Our team retrospectively summarized the patients who underwent
        transabdominal transanal endoscopic resection and reconstruction of anastomotic stenosis
        (l-taTME), and initially demonstrated the safety and effectiveness of this surgical method,
        with a stoma closure rate of 90%. Although the advantages of l-taTME in the treatment of
        severe rectal anastomotic stenosis are obvious in theory and preliminary clinical practice,
        there is a lack of prospective studies. Therefore, the investigators plan to conduct a
        prospective clinical study to observe the safety and efficacy of l-taTME reconstruction
        surgery, and to provide high-level evidence-based medical basis for the selection of
        resection and reconstruction surgery for patients with rectal anastomotic stenosis.
  Colorectal cancer is the most common malignant tumor of the digestive tract. At present,
        surgery is still the main treatment for rectal cancer. Although stapler anastomosis improves
        the safety of surgical resection and reconstruction for middle and low rectal cancer,
        surgical complications, especially anastomotic leakage, are inevitable, especially for middle
        and low rectal cancer, where the incidence of anastomotic leakage reaches 8-11%. The outcome
        of anastomotic leakage will lead to anastomotic stenosis, especially in middle and low rectal
        cancer after neoadjuvant radiotherapy, and the incidence of anastomotic stenosis is as high
        as 3%-10%. Previous studies have suggested that anastomotic diameter < 20mm is considered as
        an anastomotic stenosis, and it has also been shown that an anastomotic diameter less than
        1/3 of the original diameter of the intestinal lumen is considered as an anastomotic
        stenosis. Anastomotic stenosis can not only cause intestinal obstruction symptoms, such as
        abdominal distension and abdominal pain, but also be accompanied by frequent defecation,
        which affects the quality of life, and many patients face the outcome of permanent stoma or
        temporary stoma again.
  
        Anastomotic stenosis is divided into membranous stenosis and tubular stenosis according to
        the degree of stenosis. For anastomotic membranous stenosis, endoscopic incision of the
        stenosis ring or balloon dilatation is the preferred method for the treatment of membranous
        stenosis. However, endoscopic scar incision and balloon dilation require repeated, multiple
        treatments to achieve long-term effectiveness, with the risk of perforation, pelvic
        infection, and bleeding. Balloon dilatation or scar incision has little effect on patients
        with low anastomosis position or tubular stenosis, and nearly 30% of patients need to undergo
        resection and reconstruction of the stenotic anastomosis. As anastomotic stenosis is often
        caused by anastomotic leakage, anastomotic ischemia, radiotherapy and chemotherapy, use of
        stapler, pelvic infection and low anastomosis, the anatomical structure is unclear, the scar
        around the bowel is dense, and complications such as ureteral and urethral injury and massive
        bleeding of presacral veins are more likely to occur during the resection and reconstruction
        of the stricture. Lefevre et al. reported 33 patients who underwent resection and
        reconstruction of transabdominal rectal anastomotic stenosis, and the incidence of
        perioperative complications was 54.5%, including anastomotic leakage of 18%（6/33） and
        postoperative intestinal obstruction of 12%. Genser et al. reported 50 patients with surgical
        treatment of anastomotic stenosis, of whom 12（24%） received intraoperative blood transfusion,
        with an average blood transfusion volume of 2.5 units. The incidence of intraoperative
        complications was 12%, including 5 cases of bladder injury and 1 case of splenectomy due to
        splenic injury due to unclear anatomical location. Westerduin et al. summarized 59 patients
        who underwent secondary surgery for anastomotic leakage and stenosis, and 41% of them had
        recurrent anastomotic leakage 14 months after surgery. During the follow-up of 27 months,
        only 66% of the patients regained intestinal continuity,24%of the patients received permanent
        colostomy, and 10% of the patients retained ileostomy.
  
        Due to the difficulty of surgery, it is difficult to remove the scar tissue around the
        anastomosis in the traditional abdominal resection and reconstruction surgery. The new
        rectorectum cannot be pulled out and anastomosed with the distal rectoanal canal again. After
        reluctant anastomosis, the incidence of anastomotic leakage is still high due to the high
        tension of rectorectum, and many patients have to accept permanent stoma. Transanal total
        mesorectal excision (taTME), which uses a transanal approach to perform total mesorectal
        excision, has been demonstrated by our team for the surgical treatment of middle and low
        rectal cancer with difficult pelvis. However, the use of taTME in the treatment of
        anastomotic stenosis is rarely explored at present. Our team first reported this surgical
        method in 2021. The investigators retrospectively summarized 17 patients who underwent
        resection and reconstruction of anastomotic stenosis by transabdominal transanal endoscopic
        surgery. The ileostomy or colostomy was closed in 15 patients, which proved the safety and
        effectiveness of this surgical method. Transabdominal transanal endoscopic resection and
        reconstruction surgery has obvious advantages in the treatment of patients with rectal
        anastomotic stenosis. First, it can accurately separate the narrow distal intestine, and
        transanal anastomosis of the substitute rectum and the distal rectoanal canal can be
        performed, which reduces the difficulty of reconstruction. Secondly, from the distal normal
        anorectal canal, it can enter the normal anatomical structure space, and the narrow scar
        segment can be completely resected by endoscopic magnification. At the same time, it can
        reduce the accidental injury of the surrounding normal tissue and significantly reduce the
        incidence of intraoperative complications. Finally, the mobilization of the left hemicolon
        and splenic flexure of the abdomen was completed laparoscopically, and the specimen was
        removed through the anus, which did not require additional abdominal incision and thus
        reduced trauma. Although the advantages of transanal transabdominal combined with
        laparoscopic resection and reconstruction in the treatment of severe rectal anastomotic
        stenosis are very obvious in theory and preliminary clinical practice, there is a lack of
        prospective studies.
  
        For the above reasons, the investigators plan to conduct a prospective clinical study to
        observe the safety and efficacy of transanal laparoscopic resection and reconstruction in
        patients with rectal anastomotic stenosis, in order to improve the quality of life of
        patients with rectal anastomotic stenosis, and to provide high-level evidence-based medical
        basis for the selection of resection and reconstruction surgery for patients with rectal
        anastomotic stenosis.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Stoma recovery rate
  time frame: 3 months after surgery
  description: whether the stoma recovery and restoration of bowel continuation
  measure: incidence of postoperative anastomotic leakage
  time frame: 1 month after surgery
  description: whether the occurence of anastomotic leakage
  measure: incidence of postoperative anastomotic bleeding
  time frame: Duration of 7 days after surgery
  description: whether the occurence of anastomotic bleeding
  measure: Incidence of severe bowel dysfunction
  time frame: 3 months after stoma recovery
  description: Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)
  measure: Incidence of severe bowel dysfunction
  time frame: 6 months after stoma recovery
  description: Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)
  measure: Incidence of severe bowel dysfunction
  time frame: 1 year after stoma recovery
  description: Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)
  measure: Incidence of severe bowel dysfunction
  time frame: 2 years after stoma recovery
  description: Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)
  measure: Anorectal function
  time frame: 1 year after stoma recovery
  description: Anorectal pressure Rectal sensory function Rectoanal reflex function
  measure: Anorectal function
  time frame: 2 year after stoma recovery
  description: Anorectal pressure Rectal sensory function Rectoanal reflex function
  measure: bowel function
  time frame: 3 months after stoma recovery
  description: Memorial Sloan-Kettering Cancer Center bowel function instrument
  measure: bowel function
  time frame: 6 months after stoma recovery
  description: Memorial Sloan-Kettering Cancer Center bowel function instrument
  measure: bowel function
  time frame: 1 year after stoma recovery
  description: Memorial Sloan-Kettering Cancer Center bowel function instrument
  measure: bowel function
  time frame: 2 year after stoma recovery
  description: Memorial Sloan-Kettering Cancer Center bowel function instrument
  measure: Quality of life evaluation after stoma closure
  time frame: 3 months
  description: European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0：poor 100:best)
  measure: Quality of life evaluation after stoma closure
  time frame: 6 months
  description: European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0：poor 100:best)
  measure: Quality of life evaluation after stoma closure
  time frame: 1 year
  description: European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0：poor 100:best)
  measure: Quality of life evaluation after stoma closure
  time frame: 2 years
  description: European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0：poor 100:best)
  measure: Quality of life evaluation after stoma closure
  time frame: 3 years
  description: European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0：poor 100:best)
  measure: Inraoperative condition
  time frame: In the process of operation
  description: operation time and whether to convert to laparotomy
  measure: Perioperative recovery time
  time frame: perioperative period
  description: Duration of analgesics in hours For the first time the exhaust time in hours Time to first defecation in hours Time to first fluid intake in hours Time to resume normal diet in hours Abdominal drainage tube removal time in days Catheter removal time in days Length of postoperative hospital stay in days
  arm group label: Patients with severe rectal anastomotic stenosis
  arm group type: Experimental
  description: Focusing on Patients with severe rectal anastomotic stenosis, espically long length and ultra lower firbrotic stenosis
  intervention type: Procedure
  intervention name: Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstruction
  description: Laparoscopic or open surgery was selected according to the patient's condition, surgical history and surgeon's experience.According to the extent of the rectal stenosis, the proximal colon was dissected.A circular incision was made above the dentate line and the broken end was sutured. After the intestinal cavity was closed, a single port was inserted through the anus, and a transanal endoscopic platform was established after pneumoperitoneum infusion.The stenotic and scar segments were removed free upward.Through the pelvic cavity and into the abdominal cavity from the bottom up. The narrow rectum and proximal colon were pulled out of the anus through the anus, and the diseased bowel was removed. According to the distance of the remaining distal rectum, stapler or manual anastomosis or Bacon operation was selected.
  arm group label: Patients with severe rectal anastomotic stenosis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Yanhong Deng, Doctor
  role: Principal Investigator
  affiliation: Sun Yat-sen University
  last name: Liang Huang, Doctor
  phone: 15989101216
  email: huangl75@mail.sysu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
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  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Yanhong Deng
  investigator title: Principal investigator of the sixth affiliated hospital of Sun Yat-sen University
  mesh term: Constriction, Pathologic