Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252250
• Other study ID #: 20141056
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: November 2020

Study information

• Verified date: November 2023
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Procedure:
• conventional laparoscopic total mesentery excision
conventional laparoscopic total mesentery excision
• transanal hybrid-laparoscopic total mesentery excision
transanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA.

Locations

Country	Name	City	State
China	Daping hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	defecating functional outcomes	constipation score and incontinence score	1-6 years
Other	sexual functional outcomes	We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (International Index of Erectile Function (IIEF)	1-6 years
Other	Quality of life outcomes evaluation	We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36) and Gastro-Intestinal Functional Outcome(GIFO)) .	1-6 years
Primary	Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.	Lymph nodes number; rate of positive circumferential resection margin(CRM);	1-6 years
Secondary	Incidence of 30-day perioperative complications including intraoperative, and postoperative complications	bleeding, injury of adjacent organs, ileus, leakage, infection	0-30 days
Secondary	Incidence of long-term complications	incision hernia,	1-6 years
Secondary	Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.	overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate	1-6 years