Study of NOTES-TME Versus L-LAR in Rectal Cancer (NOTESvsL-LAR)

November 15, 2021 updated by: Xavier Serra-Aracil, Corporacion Parc Tauli

Multicenter Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Low Anterior Resection in Rectal Cancer

INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.

MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.

METHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The sample calculation is 58 patients per group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION: The laparoscopic total mesorectal excision (TME) has provided better patient recovery with less morbidity and shorter hospital stay compared with open surgery. However in laparoscopic low rectal surgery, overall conversion to open surgery is around 20%. Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.

MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.

METHODOLOGY: A prospective multicenter randomized controlled study of patients diagnosed with adenocarcinoma of the rectum that after inclusion and exclusion criteria, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The other variables studied were: demographic, surgical, pathological, 30-day morbidity and mortality, quality of life and oncologic results. The sample calculation is 53 patients per group. With an estimated loss of 10%, the final number will be 116 patients.

Study Type

Interventional

Enrollment (Actual)

116

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

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Parc Taulí University 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18 years
  • Patients with rectal cancer stage: cT1-2-3, cN0-1, cM0.
  • Tumor equal or below 10 cm from the anal verge, candidates to (ETM) low anterior resection and anastomosis, with or without preoperative chemo-radiotherapy.
  • Adenocarcinoma of low or moderate differentiation
  • ASA I, II, III.

Exclusion Criteria:

  • Do not sign informed consent
  • Pregnant patients
  • Liver cirrhosis
  • Undifferentiated adenocarcinoma.
  • cT4
  • Metastatic disease (M1)
  • chronic renal failure on dialysis
  • ASA IV
  • BMI <18 and> 35 kg / m2

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRANSANAL TOTAL MESORECTAL EXCISION
Transanal approach of total mesorectal excision.
Procedure: TRANSANAL TOTAL MESORECTAL EXCISION
The technique begins with the TEO equipment and a purse string 1 cm distal to the tumor. The dissection progresses in the posterior part until the laparoscopic TME field is reached. After the section of the rectum and TME transanal dissection, the anvil of the circular mechanical stapler is introduced through the TEO rectoscope. In the laparoscopic field, the mesosigma is sectioned at the point where the colon section is to be performed. The TEO rectoscope is withdrawn, and the bag containing the specimen is removed through the anus. The stapler is inserted. From the laparoscopic field, the strings of the purse are tightened and the purse is closed around the rectal stump with a clip. Then the stapler are joined to perform the anastomosis and a loop ileostomy is placed in the right flank.
Active Comparator: Laparoscopic-LAR
Type of surgical intervention as control group: Laparoscopic low anterior resection with total mesorectal excision for rectal cancer
Procedure: Laparoscopic-LAR
Standard laparoscopic low anterior resection of the rectum with total mesorectal excision and colorectal anastomosis
Other Names:
  • Laparoscopic Low Anterior Resecion of the rectum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer.
Time Frame: 30 days
Evaluate surgical complications 30 days after surgery.
30 days
Evaluate the effectiveness of the T-TME versus L-LAR with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CR-30 score in patients with rectal cancer.
Time Frame: 6 months
Evaluate functional results 6 months after ileostomy closure.
6 months
Evaluate the effectiveness of the T-TME versus L-LAR with the EORTC QLQ-CR29 score in patients with rectal cancer.
Time Frame: 6 months
Evaluate functional results 6 months after ileostomy closure.
6 months
Evaluate the effectiveness of the T-TME versus L-LAR with the LARS score in patients with rectal cancer.
Time Frame: 6 months
Evaluate functional results 6 months after ileostomy closure.
6 months

Collaborators and Investigators

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

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Serra-Aracil Xavier, MD, PhD, Corporacio Parc Tauli. Parc Tauli University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOTES-LRAB_TAU-2015

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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