Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07346534

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Low Rectal Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People's Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 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.

Primary outcomes

  1. Incidence of Anastomotic Leakage

    Time frame: Within 30 days postoperatively

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

Secondary outcomes

  1. Postoperative Complication Rate

    Time frame: Up to 30 days after surgery

    Incidence of Clavien-Dindo grade II or higher complications.

  2. Operation Time

    Time frame: During the surgical procedure

    Total duration of surgery from skin incision to skin closure.

  3. Length of Postoperative Hospital Stay

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

    Number of days from surgery to hospital discharge.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.