Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer

November 23, 2023 updated by: Weidong Tong, Third Military Medical University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Daping Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional laparoscopic
conventional laparoscopic total mesentery excision surgery for rectal cancer.
Procedure: conventional laparoscopic total mesentery excision
conventional laparoscopic total mesentery excision
Other Names:
  • LTME
Experimental: Transanal hybrid-laparoscopic
Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer.
Procedure: 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.
Other Names:
  • TLTME

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
defecating functional outcomes
Time Frame: 1-6 years
constipation score and incontinence score
1-6 years
sexual functional outcomes
Time Frame: 1-6 years
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
Quality of life outcomes evaluation
Time Frame: 1-6 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Investigators

  • Principal Investigator: Weidong Tong, Prof, Daping Hospital, Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimated)

September 30, 2014

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20141056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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