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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)

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

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

NCT ID

NCT02279771

First Posted

October 29, 2014

Last Updated

January 8, 2022

Sponsor

Donato F Altomare

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

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

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

donatofrancesco.altomare@uniba.it

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Di Lena, MD

Phone

+390805592107

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

Citations:

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Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

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