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NCT Number: NCT02252250

Transanal Total Mesorectal Excision Versus Laparoscopic TME 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.

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daping hospital

Chongqing, Chongqing Municipality, 400042, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional laparoscopic total mesentery excision

Procedure

conventional laparoscopic total mesentery excision

Other names: LTME

transanal hybrid-laparoscopic total mesentery excision

Procedure

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

Primary outcomes

  1. 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);

Secondary outcomes

  1. Incidence of 30-day perioperative complications including intraoperative, and postoperative complications

    Time frame: 0-30 days

    bleeding, injury of adjacent organs, ileus, leakage, infection

  2. Incidence of long-term complications

    Time frame: 1-6 years

    incision hernia,

  3. 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

Other outcomes

  1. defecating functional outcomes

    Time frame: 1-6 years

    constipation score and incontinence score

  2. 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)

  3. 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)) .

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Sep 30, 2014
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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