The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients

NCT06204497 | Completed DMC

• 1 other identifier: SRRSH.SDT
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 20

Brief Summary

The goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique (SDT) versus ileostomy in rectal cancer patients. After the removal of the rectal tumor, participants who are at high risk for anastomotic leakage will either undergo SDT or ileostomies. Researchers will compare SDT to see if SDT could help patients save hospital stays, lower medical costs, and enhance their quality of life, and not alternatively avoid defunction stoma.

Conditions

Rectal Neoplasms

Keywords

Stent-based diverting technique; Ileostomy; Complication; Anastomotic leakage

Outcome Measures

Primary Outcomes (1)

• Incidence of severe complications within 90-day

  Clavein-Dindo≥III

  Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma.

Secondary Outcomes (5)

• Total complications

  Study group, from SDT to postoperative 90 days; Control group, from ileostomy, plus interval time before stoma reversal, to postoperative 90 days of reversal of stoma

• Clinical anastomotic leakage

  Study group, from SDT to postoperative 90 days; Control group, from ileostomy, plus interval time before stoma reversal, to postoperative 90 days of reversal of stoma

• Postoperative hospital stay

  Study group, from SDT to discharge, and adding second postoperative hospital stay if the patient received the ileostomy. Control group, from ileostomy to discharge and from stoma reversal to discharge，up to six months for both group

• Total medical Costs

  From first admission to end of follow-up or date of death from any cause, whichever came first, assessed up to six months for both group

• Quality of life evaluation

  Study group, 90 days after SDT; Control group, 90 days after ileostomy

Study Arms (2)

Stent-based Diverting Technique

EXPERIMENTAL

For Stent-based Diverting Technique, the small intestine measuring 15 cm from the ileocecal junction was pulled out through the median incision in the lower abdomen. After a length-wise incision was established in the mesenteric margin of the small intestine, the degradable stent was implanted, and the intestine was sutured. Then, the stent was held in place using an external tie around the bowel. Next, a mushroom-like tube (28 Fr) was placed into the intestine proximal (5-10 cm) to the aforementioned stent. The other side of the mushroom-like tube was inserted through the right lower abdominal wall and connected with a drainage bag. An abdominal drainage tube, or an anal tube, if necessary, was inserted in the proper location prior to the closure of the incision and the abdominal cavity. Abdominal X-ray was routinely performed every week to detect stent degradation, and the mushroom-like tube (28 Fr) was removed two days after stent degradation.

Procedure: Stent-based Diverting Technique

Ileostomy

ACTIVE COMPARATOR

There will be an ileostomy for the control group. An incision with a diameter of 2 cm will be performed in the lower abdomen, and layers will be separated into the abdominal cavity. The intestine, 20cm to the ileocecal juction under laparoscopic vision, will be pulled out. The anterior sheath of the rectus abdominis and the serous layer of the intestine will be sutured with an absorbable line. Then, the middle point of the mesangial margin of the intestine will be transected, and the intestine will be fixed on the skin. No volvulus or angular formation of the intestine should be confirmed laparoscopically.

Procedure: Stent-based Diverting Technique

Interventions

Stent-based Diverting Technique PROCEDURE

The stent-based diverting technique (SDT) contains two parts to achieve feces diversion One is a degradable solid intestinal stent to be implanted 20 cm from the terminal ileum and could be gradually degraded within 3-4 weeks. Another part is a drainage tube to be placed at the proximal 5-10 cm of the aforementioned stent. Given this SDT, intestinal contents could be diverted through the drainage tube, and the stent prevents the feces from entering the distal intestinal. After removing the drainage tube after 3-4 weeks, intestinal contents will freely access the distal intestinal space following the degradation of the stent. For patients, stoma reversal is avoided.

Ileostomy; Stent-based Diverting Technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rectal adenocarcinoma confirmed pathologically.
• Rectal cancer patients with high-risk of anastomotic leakage(AL).
• Age from over 18 to under 80 years.
• Performance status of 0/1 on ECOG (Eastern Cooperative Oncology Group) scale.
• ASA (American Society of Anesthesiology) score class I, II, or III.
• Written informed consent.
• Definition of high-risk of AL (one of them):
• Preoperative body mass index (BMI) ≥30 kg/m2;
• Long-term use of glucocorticoids before surgery (≥2 weeks);
• Poor general condition: Preoperative serum albumin was less than 30.0g/L after supportive treatment; or Preoperative renal replacement therapy (blood purification/hemodialysis) is required; or diabetes;
• Preoperative neoadjuvant radiotherapy;
• Distance between tumor and anal anus (baseline MRI) ≤7cm
• The number of stapler used to cut the rectum during the operation ≥3; or the defect of anastomosis is observed; or Intraoperative leak test was positive.

You may not qualify if:

• History of previous rectectomy, except endoscopic mucosal resection or endoscopic submucosal dissection.
• Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active colitis ulcerosa.
• History of unstable angina, myocardial infarction, cerebrovascular accident within the past six months.
• Groups who are particularly vulnerable include those who suffer from mental disease, cognitive impairment, severe illness, adolescents, illiterates, women during pregnancy or breast-feeding, etc.
• Patients with severe complications who do not tolerate surgery or need emergency surgery due to complication (bleeding, obstruction or perforation)
• Unable ot radical resection, or underwent Miles or Hartmann or TaTME procedure, or requirement of simultaneous surgery for other disease (except the gallblader or appendix due to benign lesion).

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (20)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

Cancer Hospital, Peking University

Beijing, Beijing Municipality, 100000, China

Location

Peking Union Hospital

Beijing, Beijing Municipality, 100000, China

Location

Chinese PLA General Hospita

Beijing, Beijing Municipality, 310000, China

Location

Fujian Union Hospital, Fujian Medical University

Fuzhou, Fujian, 350000, China

Location

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Xiangya Hospital, Central South Universit

Changsha, Hunan, 410000, China

Location

The First Affiliated Hospital, Jilin University

Jilin, Jilin, 132000, China

Location

Shengjing Hospital, China Medical University

Shenyang, Liaoning, 110000, China

Location

The Affiliated Hospital, Qingdao University

Qingdao, Shandong, 266000, China

Location

Cancer Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

ChangHai Hospital, The Second Military Medical University

Shanghai, Shanghai Municipality, 200000, China

Location

Sichuan Cancer Hospital, University of Electronic Science and Technology of China

Chengdu, Sichuan, 610000, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China

Location

Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Location

The First Affiliated Hospital, Ningbo University

Ningbo, Zhejiang, 315000, China

Location

The Second Affiliated Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

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• Mrak K, Uranitsch S, Pedross F, Heuberger A, Klingler A, Jagoditsch M, Weihs D, Eberl T, Tschmelitsch J. Diverting ileostomy versus no diversion after low anterior resection for rectal cancer: A prospective, randomized, multicenter trial. Surgery. 2016 Apr;159(4):1129-39. doi: 10.1016/j.surg.2015.11.006. Epub 2015 Dec 17.

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MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• XiuJun Cai, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The masking in this study is inappropriate because the patients in the SDT group do not have an abdominal stoma.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of General Surgery, Principal Investigator, Clinical Professor

Model Details: The patients who were enrolled will either undergo ileostomy or SDT after the removal of the rectal tumor, which will be decided by chance.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 12, 2024
• Study Start: January 31, 2024
• Primary Completion: September 28, 2025
• Study Completion: September 28, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (20)