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

N/AEnrolling By InvitationNCT07346534

Shanghai 10th People's Hospital300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Low Rectal Cancer

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.

Conventional Laparoscopic Dixon ProcedurePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Within 30 days postoperatively

Secondary Outcomes

Postoperative Complication Rate

Incidence of Clavien-Dindo grade II or higher complications.

Time frame: Up to 30 days after surgery

Operation Time

Total duration of surgery from skin incision to skin closure.

Time frame: During the surgical procedure

Length of Postoperative Hospital Stay

Number of days from surgery to hospital discharge.

Time frame: From date of surgery through date of discharge, up to 30 days