Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reinforced Anastomotic Suturing (8-10 Interrupted Sutures), Conventional Laparoscopic Dixon Procedure.
- Who it may be relevant to
- Registry conditions: Low Rectal Cancer, Rectal Neoplasms, Colorectal Cancer. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Procedure 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. - 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.
Primary outcome measures
- Incidence of Anastomotic Leakage [Time frame: Within 30 days postoperatively]
Secondary outcome measures (3)
- Postoperative Complication Rate [Time frame: Up to 30 days after surgery]
- Operation Time [Time frame: During the surgical procedure]
- Length of Postoperative Hospital Stay [Time frame: From date of surgery through date of discharge, up to 30 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Shanghai Tenth People's Hospital — Shanghai
Identifiers
NCT: NCT07346534 · 25K50