Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Compara… (NCT07346534) | Clinical Trial Compass
By InvitationNot Applicable
Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study
China300 participantsStarted 2022-06-01
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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).