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

Tongji University

Status: Invitation-only

Conditions: Low Rectal Cancer; Rectal Neoplasms; Colorectal Cancer

Treatments: Procedure: Conventional Laparoscopic Dixon Procedure; Procedure: Reinforced Anastomotic Suturing (8-10 Interrupted Sutures)

Study type: Interventional

Funder types: Other

Identifiers

NCT07346534

25K50

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Reinforced Anastomosis with 8-10 Interrupted Sutures

Experimental group

Description:

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.

Treatment:

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

Conventional Dixon Procedure

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Laparoscopic Dixon Procedure