Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery (LessStoReS)

January 8, 2022 updated by: Donato F Altomare

Multicenter Randomized Controlled Trial of Transanal Reinforcement of Low Rectal Anastomosis Versus Protective Ileostomy in the Prevention of Anastomotic Leak After Rectal Cancer Surgery

Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

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 Contact

Study Contact Backup

Study Locations

  • Italy
      • Bari, Italy, 70100
        • Recruiting

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

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Resectable, histologically proven primary adenocarcinoma of the medium-low rectum without internal and/or external sphincter muscle involvement.

Distal margin of the tumor at least 6 cm form the anal verge

Staged as follows prior to neoadjuvant chemoradiation:

Stage T2 - T4 at MRI N0-2 at MRI M0/M1 at CT scan Patient classified T3-T4 must undergo neoadjuvant chemoradiation with at least 8 weeks delay of surgery

Exclusion Criteria:

  • Squamous cell carcinoma
  • Adenocarcinoma Stage T1,
  • T4 with one of the following:

with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total)

  • Unresectable primary rectal cancer or Inability to complete R0 resection.
  • Rectal cancer under 6 cm from the anal verge requiring colo-anal anastomosis
  • Recurrent rectal cancer
  • Previous pelvic malignancy
  • Inability to sign informed consent
  • Pregnancy

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transanal anastomotic reinforcement
Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)
Procedure: transanal anastomotic reinforcement

a circular anal dilator (CAD) of 34mm in diameter will be introduced into the anus to facilitate the transanal introduction of the 29-31 circular stapler. The stapler shaft will be introduced trying to avoid the stapler line and connected with the anvil of the prepared proximal colon and then fired.

Patients selected on the TAR-LAR arm will have the stapled suture reinforced by 6 supplemental full thickness stitches in vycril 3/0 placed transanally with the aid of a semicircular valve introduced into the CAD (Epo Flier, SapiMed SPA, Alessandria, Italy), at hours 2-4-6-8-10-12.

Device: a circular anal dilator (CAD)
Epo Flier, SapiMed SPA, Alessandria, Italy
Active Comparator: protective ileostomy group
Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)
Procedure: protective ileostomy group
S-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anastomotic leak
Time Frame: 30 postoperative days
anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis
30 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of the two operations
Time Frame: Intraoperative
the duration in minutes of the two types of operation
Intraoperative
Number of overall postoperative complications
Time Frame: 30 postoperative days
30 postoperative days

Collaborators and Investigators

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

Sponsor

Donato F Altomare

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

January 1, 2015

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 30, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 8, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Siccr/2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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