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/NCT06010043</url>
    </required_header>
    <id_info>
      <org_study_id>XHEC-2023-D-146</org_study_id>
      <nct_id>NCT06010043</nct_id>
    </id_info>
    <brief_title>&quot;Dumpling Suture Method&quot; Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study</brief_title>
    <official_title>&quot;Dumpling Suture Method&quot; Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study</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. The study aimed&#xD;
        to introduce the &quot;Dumpling suture method&quot; of protective loop ileostomy in laparoscopic&#xD;
        anterior resection and compare this new method with the traditional method. From August 1st&#xD;
        2019 to August 1st 2023, 22 cases of the new procedure were completed in our center, and 30&#xD;
        patients with stoma closure by the traditional method were included in the same period for&#xD;
        control purposes. A retrospective analysis was conducted on 52 patients in the study center,&#xD;
        and the intraoperative details and postoperative outcomes of the two groups were measured.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2019</start_date>
    <completion_date type="Actual">August 15, 2023</completion_date>
    <primary_completion_date type="Actual">August 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-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="Actual">52</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. All patients underwent successful laparoscopic anterior rectal resection plus&#xD;
               protective loop ileostomy with specimen extraction through stoma incision;&#xD;
  &#xD;
            2. All patients were pathologically diagnosed with rectal carcinoma or ulcerative&#xD;
               colitis;&#xD;
  &#xD;
            3. Patients aged 18 - 80 years&#xD;
  &#xD;
            4. ASA (American Society of Anesthesiologists) classification ≤ grade 3.&#xD;
  &#xD;
            5. Patient participate voluntarily and sign an informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with distant metastasis;&#xD;
  &#xD;
            2. Patients with colon cancer;&#xD;
  &#xD;
            3. Patients with a history of previous abdominal surgery;&#xD;
  &#xD;
            4. ASA (American Society of Anesthesiologists) classification &gt; grade 3;&#xD;
  &#xD;
            5. Patients who underwent emergency surgery;&#xD;
  &#xD;
            6. Patients who underwent surgery ≤ 3 weeks from the last chemotherapy ;&#xD;
  &#xD;
            7. Patients lost to follow-up.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200092</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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>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/NCT06010043
  org study id: XHEC-2023-D-146
  nct id: NCT06010043
  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. The study aimed
        to introduce the "Dumpling suture method" of protective loop ileostomy in laparoscopic
        anterior resection and compare this new method with the traditional method. From August 1st
        2019 to August 1st 2023, 22 cases of the new procedure were completed in our center, and 30
        patients with stoma closure by the traditional method were included in the same period for
        control purposes. A retrospective analysis was conducted on 52 patients in the study center,
        and the intraoperative details and postoperative outcomes of the two groups were measured.
  allocation: Non-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: 80 Years
  healthy volunteers: No
  facility: 
  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: Clinical Study Report (CSR)