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

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
transanal anastomotic reinforcement
protective ileostomy group
a circular anal dilator (CAD)
Sponsored by
Donato F Altomare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring colorectal anastomosis, anastomotic leak, ileostomy, complications

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

transanal anastomotic reinforcement

protective ileostomy group

Arm Description

Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)

Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)

Outcomes

Primary Outcome Measures

anastomotic leak
anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis

Secondary Outcome Measures

duration of the two operations
the duration in minutes of the two types of operation
Number of overall postoperative complications

Full Information

First Posted
October 29, 2014
Last Updated
January 8, 2022
Sponsor
Donato F Altomare
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1. Study Identification

Unique Protocol Identification Number
NCT02279771
Brief Title
Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery
Acronym
LessStoReS
Official Title
Multicenter Randomized Controlled Trial of Transanal Reinforcement of Low Rectal Anastomosis Versus Protective Ileostomy in the Prevention of Anastomotic Leak After Rectal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Donato F Altomare

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
colorectal anastomosis, anastomotic leak, ileostomy, complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transanal anastomotic reinforcement
Arm Type
Active Comparator
Arm Description
Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)
Arm Title
protective ileostomy group
Arm Type
Active Comparator
Arm Description
Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)
Intervention Type
Procedure
Intervention Name(s)
transanal anastomotic reinforcement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
protective ileostomy group
Intervention Description
S-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region.
Intervention Type
Device
Intervention Name(s)
a circular anal dilator (CAD)
Intervention Description
Epo Flier, SapiMed SPA, Alessandria, Italy
Primary Outcome Measure Information:
Title
anastomotic leak
Description
anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis
Time Frame
30 postoperative days
Secondary Outcome Measure Information:
Title
duration of the two operations
Description
the duration in minutes of the two types of operation
Time Frame
Intraoperative
Title
Number of overall postoperative complications
Time Frame
30 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donato F Altomare, MD
Phone
3397593066
Email
donatofrancesco.altomare@uniba.it
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Di Lena, MD
Phone
+390805592107
Email
mariadilena@libero.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arcangelo Picciariello, MD
Organizational Affiliation
Societa Italiana di Chirurgia ColoRettale
Official's Role
Principal Investigator
Facility Information:
City
Bari
ZIP/Postal Code
70100
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

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