Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study

NCT07346534 | Enrolling By Invitation

• 1 other identifier: 25K50
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Study Description This prospective, controlled clinical study aims to compare the clinical outcomes of reinforced anastomosis using 8-10 interrupted sutures versus the conventional Dixon procedure in patients undergoing laparoscopic low anterior resection for low rectal cancer. Anastomotic leakage remains one of the most significant postoperative complications following low rectal cancer surgery, particularly in laparoscopic procedures due to limited tactile feedback and maneuverability in the pelvic cavity. Reinforcement of the anastomotic site through additional interrupted suturing may provide better mechanical strength and improved healing, potentially reducing the incidence of anastomotic leakage and related morbidities. In this study, eligible patients will be assigned to receive either a conventional laparoscopic Dixon procedure or the same procedure with added reinforcement of the anastomosis using 8-10 interrupted sutures circumferentially. Perioperative outcomes including the rate of anastomotic leakage, postoperative complications, operation time, length of hospital stay, return of bowel function, and quality of life will be assessed and compared between the two groups. The study seeks to provide evidence for optimizing surgical techniques in low rectal cancer treatment and improving patient prognosis.

Conditions

Low Rectal Cancer; Rectal Neoplasms; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Anastomotic Leakage

  Defined as clinically significant leakage confirmed by radiological or surgical evidence, classified according to International Study Group of Rectal Cancer (ISREC) criteria.

  Within 30 days postoperatively

Secondary Outcomes (3)

• Postoperative Complication Rate

  Up to 30 days after surgery

• Operation Time

  During the surgical procedure

• Length of Postoperative Hospital Stay

  From date of surgery through date of discharge, up to 30 days

Study Arms (2)

Reinforced Anastomosis with 8-10 Interrupted Sutures

EXPERIMENTAL

Patients in this group will undergo laparoscopic low anterior resection (Dixon procedure) for low rectal cancer, followed by reinforcement of the anastomosis using 8-10 interrupted seromuscular sutures circumferentially around the stapled anastomotic site. The reinforcement is intended to enhance anastomotic integrity and reduce the risk of leakage.

Procedure: Reinforced Anastomotic Suturing (8-10 Interrupted Sutures)

Conventional Dixon Procedure

ACTIVE COMPARATOR

Patients in this group will undergo standard laparoscopic low anterior resection (Dixon procedure) for low rectal cancer without additional reinforcement of the anastomosis. The anastomosis will be performed using a circular stapler alone, as per conventional practice.

Procedure: Conventional Laparoscopic Dixon Procedure

Interventions

Reinforced Anastomotic Suturing (8-10 Interrupted Sutures) PROCEDURE

After completing the laparoscopic low anterior resection (Dixon procedure) for low rectal cancer, the surgeon performs additional reinforcement of the colorectal anastomosis. This is done by placing 8 to 10 interrupted seromuscular sutures circumferentially around the anastomotic site. The goal of this reinforcement is to enhance anastomotic stability, promote healing, and reduce the risk of anastomotic leakage.

Reinforced Anastomosis with 8-10 Interrupted Sutures

Conventional Laparoscopic Dixon Procedure PROCEDURE

Patients undergo standard laparoscopic low anterior resection (Dixon procedure) for low rectal cancer. The colorectal anastomosis is performed using a circular stapler without any additional suturing or reinforcement. This represents the conventional surgical approach widely used in clinical practice.

Conventional Dixon Procedure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 85 years.
• Diagnosed with low rectal adenocarcinoma located within 7 cm from the anal verge by colonoscopy and biopsy.
• Scheduled for elective laparoscopic low anterior resection (Dixon procedure).
• Clinical stage I-III (based on preoperative imaging, e.g., MRI/CT) without distant metastasis.
• Adequate organ function (hematologic, hepatic, renal) to tolerate surgery.
• Provided written informed consent and willing to comply with study procedures and follow-up.

You may not qualify if:

• Presence of synchronous distant metastases or other malignancies.
• History of prior pelvic radiotherapy or major pelvic surgery.
• Severe uncontrolled comorbidities (e.g., severe cardiovascular, respiratory, hepatic or renal insufficiency).
• Emergency surgery indication (e.g., bowel obstruction, perforation).
• Pregnancy or breastfeeding.
• Known allergy or contraindication to anesthesia or surgical materials used.
• Participation in another interventional clinical trial within the last 3 months.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator assistant

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: January 16, 2026
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)