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

NCT ID: NCT07346534

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2026-12-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Reinforced Anastomosis with 8-10 Interrupted Sutures

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.

Group Type: EXPERIMENTAL

Reinforced Anastomotic Suturing (8-10 Interrupted Sutures)

Intervention Type: 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.

Conventional Dixon Procedure

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.

Group Type: ACTIVE_COMPARATOR

Conventional Laparoscopic Dixon Procedure

Intervention Type: 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.

Interventions

Reinforced Anastomotic Suturing (8-10 Interrupted Sutures)

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.

Intervention Type: PROCEDURE

Conventional Laparoscopic Dixon 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 85 years.

2. Diagnosed with low rectal adenocarcinoma located within 7 cm from the anal verge by colonoscopy and biopsy.

3. Scheduled for elective laparoscopic low anterior resection (Dixon procedure).

4. Clinical stage I-III (based on preoperative imaging, e.g., MRI/CT) without distant metastasis.

5. Adequate organ function (hematologic, hepatic, renal) to tolerate surgery.

6. Provided written informed consent and willing to comply with study procedures and follow-up.

Exclusion Criteria

1. Presence of synchronous distant metastases or other malignancies.

2. History of prior pelvic radiotherapy or major pelvic surgery.

3. Severe uncontrolled comorbidities (e.g., severe cardiovascular, respiratory, hepatic or renal insufficiency).

4. Emergency surgery indication (e.g., bowel obstruction, perforation).

5. Pregnancy or breastfeeding.

6. Known allergy or contraindication to anesthesia or surgical materials used.

7. Participation in another interventional clinical trial within the last 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Feng-Min

Investigator assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Tenth People's Hospital

Shanghai, , China

Countries

China

Other Identifiers

25K50

Identifier Type: -

Identifier Source: org_study_id