NCT07346534Enrolling by invitation
Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 1 Jun 2022
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Shanghai 10th People's Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07346534
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Jun 2022 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior pelvic radiotherapy or major pelvic surgery.
Other illness
- Presence of synchronous distant metastases or other malignancies.
- Severe uncontrolled comorbidities (e.g., severe cardiovascular, respiratory, hepatic or renal insufficiency).
- Emergency surgery indication (e.g., bowel obstruction, perforation).
- Known allergy or contraindication to anesthesia or surgical materials used.
Other
- Pregnancy or breastfeeding.
- Participation in another interventional clinical trial within the last 3 months.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.