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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02252250
Other study ID # 20141056
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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