Prospective Phase II Study on Continuous Circumferential Reinforcement of Laparoscopic Rectal Anastomosis to Prevent Complications

NCT06495853 | Not Yet Recruiting Phase 2

• 1 other identifier: 2023-FXY-182
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

Anastomotic leakage (AL) is one of the most severe complications following laparoscopic rectal cancer surgery. According to the International Study Group of Rectal Cancer (ISREC), AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomosis leading to a communication between the intra- and extraluminal compartments, including defects of the suture or staple lines of the neorectal reservoir. AL is classified into three grades based on clinical severity: Grade A, identified only radiologically without clinical symptoms; Grade B, presenting with localized or atypical peritonitis requiring antibiotics and local drainage but not surgery; and Grade C, causing severe peritonitis, systemic toxicity symptoms requiring urgent surgical intervention, and potentially leading to life-threatening situations. AL can prolong hospitalization, necessitate reoperation, delay chemotherapy, increase local recurrence rates, and adversely affect survival and quality of life. Emergency surgical management of AL often requires meticulous peritoneal lavage and ileostomy, aiming for subsequent anastomotic healing or future digestive tract reconstruction. However, some patients face significant challenges due to postoperative adhesions and persistent anastomotic defects despite prolonged lavage. Identified risk factors for AL after rectal cancer surgery include male gender, advanced age, hypertension, diabetes, smoking, and advanced TNM staging (III-IV). Additionally, preoperative chemoradiotherapy-induced bowel edema and fibrosis, bowel obstruction, and long-term malnutrition resulting in hypoproteinemia are significant contributors. Mechanical reinforcement of anastomoses using sutures or absorbable barbed sutures has been shown to significantly reduce AL rates in previous studies. This single-center prospective phase II clinical trial aims to evaluate the efficacy and safety of continuous circumferential reinforcement using absorbable barbed sutures in laparoscopic rectal anastomosis to prevent AL. We will compare the incidence of AL and other postoperative complications between patients undergoing reinforced anastomosis and a control group receiving standard laparoscopic rectal anastomosis.

Conditions

Colorectal Cancer; Anastomotic Leakage; Operation

Outcome Measures

Primary Outcomes (1)

• Incidence of Clinically and Radiologically Confirmed Anastomotic Leakage within 30 Days Postoperatively

  Clinical and radiological assessment of anastomotic leakage within 30 days postoperatively, including Grade A and B leaks detected through imaging without clinical symptoms, as well as Grade C leaks with clear clinical manifestations.

  30-days after surgery

Secondary Outcomes (5)

• Time to First Postoperative Flatus

  3-days after surgery

• Time to First Postoperative Oral Intake

  3-days after surgery

• Incidence of Postoperative Intra-abdominal Hemorrhage

  14-days after surgery

• Incidence of Postoperative Anastomotic Hemorrhage

  14-days after surgery

• Incidence of Postoperative Anastomotic Stricture

  60-days after surgery

Study Arms (2)

GroupA

EXPERIMENTAL

Patients with rectal cancer who did not receive neoadjuvant chemoradiotherapy and underwent rectal anterior resection with anastomotic reinforcement were included in Cohort A. The rectal cancer radical resection was performed in strict accordance with the principles of no-tumor technique and total mesorectal excision (TME) by experienced deputy chief physicians or higher from our research center. The procedure followed standard rectal cancer radical resection protocols. After rectal division using a linear stapler, an end-to-end anastomosis was performed using a circular stapler. For patients in the treatment group, anastomotic reinforcement was performed using absorbable Johnson \& Johnson EB403 barbed sutures laparoscopically.Unless there were clear high-risk factors for anastomotic leakage preoperatively (e.g., diabetes, narrow pelvis, unsatisfactory anastomosis, positive colonic air leak test), ileostomy was not routinely performed in this group of patients.

Procedure: Continuous Circumferential Reinforcement of the Anastomotic

Group B

EXPERIMENTAL

Patients who did not receive neoadjuvant chemoradiotherapy and underwent rectal anterior resection with anastomotic reinforcement were included in Cohort B. The rectal cancer radical resection was performed in strict accordance with the principles of no-tumor technique and total mesorectal excision (TME) by experienced deputy chief physicians or higher from our research center. The procedure followed standard rectal cancer radical resection protocols. After rectal division using a linear stapler, an end-to-end anastomosis was performed using a circular stapler. For patients in the treatment group, anastomotic reinforcement was performed using absorbable Johnson \& Johnson EB403 barbed sutures laparoscopically. Since neoadjuvant chemoradiotherapy is a high-risk factor for postoperative anastomotic leakage, ileostomy was routinely performed in this group of patients to prevent severe intra-abdominal infections caused by anastomotic leakage.

Procedure: Continuous Circumferential Reinforcement of the Anastomotic

Interventions

Continuous Circumferential Reinforcement of the Anastomotic PROCEDURE

The reinforcement began on the right side of the anterior wall of the anastomosis, 0.5 cm from the anastomotic line, with continuous full-thickness sutures spaced 1 cm apart. The suture ended with fixation of the suture tail using non-absorbable vascular clips. The decision to perform splenic flexure mobilization depended on the anastomotic tension and the length of the resected bowel segment. The superior mesenteric artery and vein were divided at their roots.

Group B; GroupA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological Confirmation:
• Diagnosed with rectal adenocarcinoma confirmed by histology.
• Tumor Location:
• MRI confirms a mid to upper rectal tumor, with the lower margin of the tumor located 6-12 cm from the anal verge.
• Preoperative Staging:
• Preoperative MRI staging indicates the presence or absence of MRF positivity and/or EMVI positivity; the surgical team assesses the tumor as resectable with an estimated R0 resection.
• Bowel Obstruction:
• No signs of bowel obstruction.
• Neoadjuvant Chemoradiotherapy:
• For patients who have received neoadjuvant chemoradiotherapy, complete radiotherapy and baseline imaging records must be available at this center.
• Previous Treatments:
• Surgical History:
• No previous colorectal surgery.
• Biological and Immunotherapy:
• No prior treatment with biological drugs (e.g., monoclonal antibodies), immunotherapy (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4), or other investigational drugs.

You may not qualify if:

• Patients meeting any of the following conditions will be excluded from the study:
• Need for Multiorgan Resection:
• Patients requiring combined organ resection.
• Preventive or Permanent Stoma:
• Patients requiring preventive or permanent stoma.
• Hartmann or Miles Procedures:
• Patients requiring Hartmann's procedure or Miles' surgery.
• Cardiac Conditions:
• Arrhythmias requiring antiarrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease, localized myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure beyond NYHA Class II.
• Uncontrolled Hypertension:
• Severe hypertension that is not well controlled by medication.
• Infectious Diseases:
• History of HIV infection or active chronic hepatitis B or C with high viral DNA copies.
• Active Tuberculosis (TB):
• Subjects with active pulmonary tuberculosis, currently undergoing anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening.

Sponsors & Collaborators

• ZHI-ZHONG PAN: lead

Study Sites (1)

Colorectal Department,SunYat-sen University Cancer Center

Guangzhou, Guangdong, 510062, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: July 20, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)