Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer

Not Applicable

Completed

• Conditions: Rectal Neoplasms
• Interventions: Procedure: transanal hybrid-laparoscopic total mesentery excision; Procedure: conventional laparoscopic total mesentery excision

• Registration Number: NCT02252250
• Lead Sponsor: Third Military Medical University

Brief Summary

To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.

Detailed Description

Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show that such NOTES procedures are feasible and safe. And also, lots of experimental studies and small case series reporting the feasibility of transanal anterior resection with single incision laparoscopic surgery(SILS) port or other devices. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function, sexual function, QOF) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive total mesentery excision for rectal cancer.

Study Timeline

• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-09-30
• Study Start: 2014-10
• Primary Completion: 2019-10
• Study Completion: 2020-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Biopsy-proven adenocarcinoma of the rectum
• Eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma
• Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI
• Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI
• Rectal cancer located 3-10 cm from the anal verge

Exclusion Criteria

• Metastasis
• Obstructing rectal cancer
• Synchronous colon cancer
• T4 rectal cancer not treated preoperatively with full-course chemoradiation
• Pregnant or breast-feeding
• Receiving any other study agents
• Fecal incontinence
• History of prior colorectal cancer
• History of inflammatory bowel disease
• History of pelvic radiation
• BMI > 40
• Large uterine fibroids
• Uncontrolled intercurrent illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transanal hybrid-laparoscopic	transanal hybrid-laparoscopic total mesentery excision	Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer.
conventional laparoscopic	conventional laparoscopic total mesentery excision	conventional laparoscopic total mesentery excision surgery for rectal cancer.

Primary Outcome Measures

Name	Time	Method
Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.	1-6 years	Lymph nodes number; rate of positive circumferential resection margin(CRM);

Secondary Outcome Measures

Name	Time	Method
Incidence of long-term complications	1-6 years	incision hernia,
Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.	1-6 years	overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate
Incidence of 30-day perioperative complications including intraoperative, and postoperative complications	0-30 days	bleeding, injury of adjacent organs, ileus, leakage, infection

Trial Locations

Locations (1)

Daping hospital; 🇨🇳 Chongqing, Chongqing, China