A Randomized Parallel-controlled Study Comparing the Ileostomy "Dumpling Suture Method" With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma

• ClinicalTrials.gov Identifier: NCT05985499
• Recruitment Status: Recruiting
• First Posted: August 14, 2023
• Last Update Posted: April 23, 2024
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Information provided by (Responsible Party): Tingyu Wu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Tracking Information

• First Submitted Date: August 3, 2023
• First Posted Date: August 14, 2023
• Last Update Posted Date: April 23, 2024
• Actual Study Start Date: March 21, 2023
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2023)

Complication rate of stoma [ Time Frame: Day 30 after surgery ]

Observe and assess for stoma complications

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 14, 2023)

• Stoma DET（Discoloration，Erosion and Tissue overgrowth） score [ Time Frame: Day 30 after surgery ]
  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
• Stoma Pain Score [ Time Frame: Day 30 after surgery ]
  Measurement of stoma pain level using numerical rating scale，ranging from 0-10, higher scores mean a worse outcome of pain
• Quality of life scale score for patients with stoma [ Time Frame: Day 30 after surgery ]
  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

Original Secondary Outcome Measures (submitted: August 3, 2023)

• Stoma DET score [ Time Frame: Day 30 after surgery ]
  Measure the state of the skin around the stoma and the corresponding lesion area
• Stoma Pain Score [ Time Frame: Day 30 after surgery ]
  Measurement of stoma pain level using a pain rating scale
• Quality of life scale score for patients with stoma [ Time Frame: Day 30 after surgery ]
  Measurement of quality of life for patients with stoma using Ostomy Patient Quality of Life Scale

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Randomized Parallel-controlled Study Comparing the Ileostomy "Dumpling Suture Method" With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma
• Official Title: A Randomized Parallel-controlled Study Comparing the Ileostomy "Dumpling Suture Method" With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma (NOSES With Specimen Extraction Via Stoma)
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Ileostomy; Complications

Intervention

• Procedure: Suturing of ileostomy using "Dumpling suture method"
  Suturing of ileostomy using "Dumpling suture method"
• Procedure: Suturing of ileostomy using Traditional suture method
  Suturing of ileostomy using Traditional suture method

Study Arms

• Experimental: "Dumpling suture" for ileostomy
  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.
  Intervention: Procedure: Suturing of ileostomy using "Dumpling suture method"
• Traditional suture for ileostomy
  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: Procedure: Suturing of ileostomy using Traditional suture method

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 3, 2023): 66
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Patients scheduled for rectal anterior resection surgery with specimen extraction via stoma
2. No serious systemic infection or immunosuppression
3. Patients aged above 18 years and below 100 years
4. Eastern Cooperative Oncology Group Performance Status: 0-1
5. Expected survival time > 6 months
6. Patient participate voluntarily and sign an informed consent form

Exclusion Criteria:

1. Patients who do not require a prophylactic stoma after preoperative evaluation
2. Any skin infectious disease of the abdominal wall
3. Surgery less than 1 month from the last chemotherapy
4. Previously underwent any other stoma surgery
5. Presence of a serious active or uncontrollable infection requiring systemic therapy
6. Previous history of definite neurological or psychiatric disorders
7. Patient may not be able to complete the study for other reasons, or who the investigator believes should not be included

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Min Shi; +86-21-25076143; xinhuahospitalec@163.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05985499
• Other Study ID Numbers: XHEC-C-2023-022-2
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)

• Current Responsible Party: Tingyu Wu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Original Responsible Party: Tingyu Wu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Dr.
• Current Study Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tingyu Wu, Doctor; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

• PRS Account: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Verification Date: April 2024