NCT02550769

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 16, 2021

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

August 31, 2015

Last Update Submit

November 15, 2021

Conditions

Rectal Cancer

Keywords

Transanal NOTESTransanal TMELaparoscopic Low Anterior ResectionSurgery

Outcome Measures

Primary Outcomes (4)

  • Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer.

    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.

    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.

    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.

    Evaluate functional results 6 months after ileostomy closure.

    6 months

Study Arms (2)

TRANSANAL TOTAL MESORECTAL EXCISION

EXPERIMENTAL

Transanal approach of total mesorectal excision.

Procedure: TRANSANAL TOTAL MESORECTAL EXCISION

Laparoscopic-LAR

ACTIVE COMPARATOR

Type of surgical intervention as control group: Laparoscopic low anterior resection with total mesorectal excision for rectal cancer

Procedure: Laparoscopic-LAR

Interventions

TRANSANAL TOTAL MESORECTAL EXCISIONPROCEDURE

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.

TRANSANAL TOTAL MESORECTAL EXCISION
Laparoscopic-LARPROCEDURE

Standard laparoscopic low anterior resection of the rectum with total mesorectal excision and colorectal anastomosis

Also known as: Laparoscopic Low Anterior Resecion of the rectum
Laparoscopic-LAR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc Tauli University Hospital

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (4)

  • Serra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27.

    PMID: 25814073BACKGROUND

  • Serra-Aracil X. [Transanal total mesorectal excision]. Cir Esp. 2014 Apr;92(4):221-2. doi: 10.1016/j.ciresp.2014.01.002. Epub 2014 Feb 24. No abstract available. Spanish.

    PMID: 24576748BACKGROUND

  • Serra-Aracil X, Zarate A, Bargallo J, Gonzalez A, Serracant A, Roura J, Delgado S, Mora-Lopez L; Ta-LaTME study Group. Transanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial. Br J Surg. 2023 Jan 10;110(2):150-158. doi: 10.1093/bjs/znac324.

    PMID: 36224406DERIVED

  • Serra-Aracil X, Zarate A, Mora L, Serra-Pla S, Pallisera A, Bonfill J, Bargallo J, Pando A, Delgado S, Balleteros E, Pericay C. Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer. Int J Colorectal Dis. 2018 May;33(5):649-655. doi: 10.1007/s00384-018-2996-8. Epub 2018 Mar 16.

    PMID: 29546560DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Serra-Aracil Xavier, MD, PhD

    Corporacio Parc Tauli. Parc Tauli University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 16, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2021

Last Updated

November 16, 2021

Record last verified: 2020-07

Locations

ES(1)