Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study
Enrolling by invitation · Not applicable
Conditions studied: Low Rectal Cancer, Rectal Neoplasms, Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT07346534
- Run by
- Shanghai 10th People's Hospital
- People needed
- 300
- Starts
- 2022-06-01
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2026-01-16
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Shanghai Tenth People's Hospital — Shanghai, China
Full record on ClinicalTrials.gov
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