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/NCT05985499</url>
    </required_header>
    <id_info>
      <org_study_id>XHEC-C-2023-022-2</org_study_id>
      <nct_id>NCT05985499</nct_id>
    </id_info>
    <brief_title>A Randomized Parallel-controlled Study Comparing the Ileostomy &quot;Dumpling Suture Method&quot; With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma</brief_title>
    <official_title>A Randomized Parallel-controlled Study Comparing the Ileostomy &quot;Dumpling Suture Method&quot; With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma (NOSES With Specimen Extraction Via Stoma)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from&#xD;
        the abdominal cavity without any incisions, has attracted much attention in recent years, and&#xD;
        it has been widely popularized in the treatment of rectal cancer because of its postoperative&#xD;
        non-incision, advantages of less trauma, quicker recovery, and postoperative aesthetics.&#xD;
        Anastomotic fistula is a serious complication of rectal cancer surgery. For patients at high&#xD;
        risk of anastomotic fistula, prophylactic ileostomy is often performed intraoperatively to&#xD;
        divert feces and protect the anastomosis. For such patients, rectal anterior resection&#xD;
        surgery with specimen extraction via stoma (NOSES with specimen extraction via stoma) is&#xD;
        usually performed, borrowing a prophylactic stoma incision to retrieve the specimen, and also&#xD;
        realizing the absence of additional abdominal incision. However, this procedure is prone to&#xD;
        stoma infection and has a high complication rate (20-40%), which limits the popularization of&#xD;
        NOSES surgery and is an urgent clinical problem. Our center has proposed a new stoma closure&#xD;
        method (Dumpling Suture Method), which reduces the size of the incision by folding the suture&#xD;
        to achieve the effect of hiding the skin incision and reduce stoma infection. In our previous&#xD;
        study, 17 cases of the new procedure were completed in our center, and 25 patients with stoma&#xD;
        closure by the traditional method were included in the same period for control purposes.&#xD;
        After six months of follow-up, we found that the &quot;dumpling suture method&quot; significantly&#xD;
        reduced the incidence of stoma complications compared with the traditional suture method&#xD;
        (5.8% vs. 36%), and no additional adverse effects were observed. This is a single-center,&#xD;
        open-label, randomized, parallel-controlled clinical study planned to recruit 66 patients&#xD;
        randomized in a 1:1 ratio to the trial and control groups. The primary endpoint is stoma&#xD;
        complication rate at 30 days postoperatively. In this study, we aim to evaluate the efficacy&#xD;
        and safety of the &quot;dumpling suture method &quot; compared with the traditional stoma suture in&#xD;
        reducing postoperative stoma complications through a randomized parallel controlled clinical&#xD;
        trial, which is of great significance for the improvement of the rectal NOSES procedure and&#xD;
        the reduction of the incidence of stoma complications.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 21, 2023</start_date>
    <completion_date type="Anticipated">March 21, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 21, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Complication rate of stoma</measure>
      <time_frame>Day 30 after surgery</time_frame>
      <description>Observe and assess for stoma complications</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Stoma DET（Discoloration，Erosion and Tissue overgrowth） score</measure>
      <time_frame>Day 30 after surgery</time_frame>
      <description>Measure the state of the skin around the stoma and the corresponding lesion area, ranging from 0-15, higher scores mean a worse outcome of stoma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stoma Pain Score</measure>
      <time_frame>Day 30 after surgery</time_frame>
      <description>Measurement of stoma pain level using numerical rating scale，ranging from 0-10, higher scores mean a worse outcome of pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life scale score for patients with stoma</measure>
      <time_frame>Day 30 after surgery</time_frame>
      <description>Measurement of quality of life for patients with stoma using City of Hope Quality of Life-Ostomy Questionnaire (CHO-QOL-OQ), ranging from 0-3200, higher scores mean a worse outcome of quality of life</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Ileostomy; Complications</condition>
    <arm_group>
      <arm_group_label>&quot;Dumpling suture&quot; for ileostomy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The stoma is fixed with sutures in a skin fold method, and the incision is progressively reduced in a process similar to the process of folding and pinching the Chinese small dumplings. This procedure may reduce stoma complications by progressively reducing the incision and realizing the effect of hiding the skin incision.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Traditional suture for ileostomy</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The stoma was fixed at the skin using traditional sutures. The incision is narrowed by 2-3 interrupted sutures at the distal and proximal ends of the skin incision on the abdominal wall. The stoma is then fixed at the right lower abdominal incision with sutures.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Suturing of ileostomy using &quot;Dumpling suture method&quot;</intervention_name>
      <description>Suturing of ileostomy using &quot;Dumpling suture method&quot;</description>
      <arm_group_label>&quot;Dumpling suture&quot; for ileostomy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Suturing of ileostomy using Traditional suture method</intervention_name>
      <description>Suturing of ileostomy using Traditional suture method</description>
      <arm_group_label>Traditional suture for ileostomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients scheduled for rectal anterior resection surgery with specimen extraction via&#xD;
               stoma&#xD;
  &#xD;
            2. No serious systemic infection or immunosuppression&#xD;
  &#xD;
            3. Patients aged above 18 years and below 100 years&#xD;
  &#xD;
            4. Eastern Cooperative Oncology Group Performance Status: 0-1&#xD;
  &#xD;
            5. Expected survival time &gt; 6 months&#xD;
  &#xD;
            6. Patient participate voluntarily and sign an informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who do not require a prophylactic stoma after preoperative evaluation&#xD;
  &#xD;
            2. Any skin infectious disease of the abdominal wall&#xD;
  &#xD;
            3. Surgery less than 1 month from the last chemotherapy&#xD;
  &#xD;
            4. Previously underwent any other stoma surgery&#xD;
  &#xD;
            5. Presence of a serious active or uncontrollable infection requiring systemic therapy&#xD;
  &#xD;
            6. Previous history of definite neurological or psychiatric disorders&#xD;
  &#xD;
            7. Patient may not be able to complete the study for other reasons, or who the&#xD;
               investigator believes should not be included&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tingyu Wu, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Min Shi</last_name>
      <phone>+86-21-25076143</phone>
      <email>xinhuahospitalec@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Xinhua Hospital, Shanghai Jiaotong University School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200092</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Min Shi</last_name>
        <phone>+86-21-25076143</phone>
        <email>xinhuahospitalec@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
      <investigator_full_name>Tingyu Wu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>ileostomy</keyword>
    <keyword>complications</keyword>
    <keyword>NOSES</keyword>
    <keyword>stoma suture</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>In this study personal information and data such as patient history, physical examination results, surgical records, and study questionnaire data will be collected. These data will be used to evaluate the efficacy and safety of the new procedure and for academic publication. The researcher will treat the patients' personal data confidentially and anonymize the data and information in any public release of the results of the study.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </patient_data>
    <!-- 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/NCT05985499
  org study id: XHEC-C-2023-022-2
  nct id: NCT05985499
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from
        the abdominal cavity without any incisions, has attracted much attention in recent years, and
        it has been widely popularized in the treatment of rectal cancer because of its postoperative
        non-incision, advantages of less trauma, quicker recovery, and postoperative aesthetics.
        Anastomotic fistula is a serious complication of rectal cancer surgery. For patients at high
        risk of anastomotic fistula, prophylactic ileostomy is often performed intraoperatively to
        divert feces and protect the anastomosis. For such patients, rectal anterior resection
        surgery with specimen extraction via stoma (NOSES with specimen extraction via stoma) is
        usually performed, borrowing a prophylactic stoma incision to retrieve the specimen, and also
        realizing the absence of additional abdominal incision. However, this procedure is prone to
        stoma infection and has a high complication rate (20-40%), which limits the popularization of
        NOSES surgery and is an urgent clinical problem. Our center has proposed a new stoma closure
        method (Dumpling Suture Method), which reduces the size of the incision by folding the suture
        to achieve the effect of hiding the skin incision and reduce stoma infection. In our previous
        study, 17 cases of the new procedure were completed in our center, and 25 patients with stoma
        closure by the traditional method were included in the same period for control purposes.
        After six months of follow-up, we found that the "dumpling suture method" significantly
        reduced the incidence of stoma complications compared with the traditional suture method
        (5.8% vs. 36%), and no additional adverse effects were observed. This is a single-center,
        open-label, randomized, parallel-controlled clinical study planned to recruit 66 patients
        randomized in a 1:1 ratio to the trial and control groups. The primary endpoint is stoma
        complication rate at 30 days postoperatively. In this study, we aim to evaluate the efficacy
        and safety of the "dumpling suture method " compared with the traditional stoma suture in
        reducing postoperative stoma complications through a randomized parallel controlled clinical
        trial, which is of great significance for the improvement of the rectal NOSES procedure and
        the reduction of the incidence of stoma complications.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Complication rate of stoma
  time frame: Day 30 after surgery
  description: Observe and assess for stoma complications
  measure: Stoma DET（Discoloration，Erosion and Tissue overgrowth） score
  time frame: Day 30 after surgery
  description: Measure the state of the skin around the stoma and the corresponding lesion area, ranging from 0-15, higher scores mean a worse outcome of stoma
  measure: Stoma Pain Score
  time frame: Day 30 after surgery
  description: Measurement of stoma pain level using numerical rating scale，ranging from 0-10, higher scores mean a worse outcome of pain
  measure: Quality of life scale score for patients with stoma
  time frame: Day 30 after surgery
  description: Measurement of quality of life for patients with stoma using City of Hope Quality of Life-Ostomy Questionnaire (CHO-QOL-OQ), ranging from 0-3200, higher scores mean a worse outcome of quality of life
  arm group label: "Dumpling suture" for ileostomy
  arm group type: Experimental
  description: The stoma is fixed with sutures in a skin fold method, and the incision is progressively reduced in a process similar to the process of folding and pinching the Chinese small dumplings. This procedure may reduce stoma complications by progressively reducing the incision and realizing the effect of hiding the skin incision.
  arm group label: Traditional suture for ileostomy
  arm group type: Other
  description: The stoma was fixed at the skin using traditional sutures. The incision is narrowed by 2-3 interrupted sutures at the distal and proximal ends of the skin incision on the abdominal wall. The stoma is then fixed at the right lower abdominal incision with sutures.
  intervention type: Procedure
  intervention name: Suturing of ileostomy using "Dumpling suture method"
  description: Suturing of ileostomy using "Dumpling suture method"
  arm group label: "Dumpling suture" for ileostomy
  intervention type: Procedure
  intervention name: Suturing of ileostomy using Traditional suture method
  description: Suturing of ileostomy using Traditional suture method
  arm group label: Traditional suture for ileostomy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Tingyu Wu, Doctor
  role: Principal Investigator
  affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  last name: Min Shi
  phone: +86-21-25076143
  email: xinhuahospitalec@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  investigator full name: Tingyu Wu
  investigator title: Principal Investigator
  sharing ipd: Yes
  ipd description: In this study personal information and data such as patient history, physical examination results, surgical records, and study questionnaire data will be collected. These data will be used to evaluate the efficacy and safety of the new procedure and for academic publication. The researcher will treat the patients' personal data confidentially and anonymize the data and information in any public release of the results of the study.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)