Prophylactic Mesh Placement During Stoma Closure After Lo... | NCT05939687

Studies
Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

NCT05939687

Sponsor

Blokhin's Russian Cancer Research Center

Status

Recruiting

Last Update Posted

Aug 7, 2024Actual

Enrollment

142Estimated

Phase

Phase 3

Conditions

Neoplasms Malignant
Rectal Cancer
Hernia Incisional
Surgery

Interventions

mesh
non-mesh

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 5, 2023Actual

Primary Completion Date

Dec 1, 2028Estimated

Completion Date

Dec 1, 2028Estimated

First Submitted Date

Jul 3, 2023

First Submission Date that Met QC Criteria

Jul 3, 2023

First Posted Date

Jul 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2024

Last Update Posted Date

Aug 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sergey Gordeyev, Principal investigator, Department of Colorectal surgery, Blokhin's Russian Cancer Research CenterPrincipal Investigator

Lead Sponsor

Blokhin's Russian Cancer Research CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study.

Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.

Detailed Description

This clinical trial is prospective randomized phase III study of the efficacy of polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer. We will include in the study group 71 patients with colorectal cancer with ileo- and colostomy. In these patients we will do sublay/interoblique repair in prevention incisional hernias using polypropylene mesh. Our hypothesis is to reduce parastomal hernias rate from 30% to 10% over 2 years. Stratification will be used for patients with >5 cm vs <5 cm stoma-site hernia.

The control group will include 71 patients with similar parameters who will undergo stoma closure with layered ligature suturing of the abdominal wall without mesh implantation.

Additional endpoints are the wound infection rate, the complication rate (Clavien-Dindo), the rate of the repeated surgery for hernia at the site of stoma closure. We'll assess the quality of life by HerQLes (Hernia-Related Quality of Life Survey) scale.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

142Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mesh	Experimental	In these patients we will do sublay/interoblique repair for prevention of stoma-site hernias using a polypropylene mesh.	Procedure: mesh
non-mesh	Active Comparator	In these patients we will close the stoma with standard layered ligature suturing of the abdominal wall without mesh implantation.	Procedure: non-mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mesh	Procedure	We'll use mesh repair for prevention of stoma-site hernias in the study group.	mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hernia rate	The rate of parastomal hernias after stoma closure for 2 years.	2 years

Secondary Outcomes

Measure	Description	Time Frame
90 day surgical morbidity	Complications after stoma closure including hernias	90 days
Quality of life indicators by HerQLes scale	Quality of life as assessed by Hernia-Related Quality of Life Survey scale (HerQLes) at 30 days, 1 year and 2 years after stoma closure (higher scores are worse)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Absence of distant metastases (M0)
ECOG (Eastern Cooperative Oncology Group) status 0-2
completed course of adjuvant treatment
Absence of acute inflammatory parastomal complications
Integrity of colorectal anastomosis

Exclusion Criteria:

Inability to obtain consent to participate
Synchronous and metachronous malignant neoplasms
Clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system
Parastomal inflammation and other conditions that increase the risk of postoperative complications
Pregnancy
HIV infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sergey Gordeyev, D.Sc.	Contact	9104501213	007	ss.netoncology@gmail.com

Overall Officials

Name	Affiliation	Role
Zaman Z Mamedli, PhD	N.N.Blokhin Russian Cancer Research Center	Study Director
Nikolay L Matveev, PhD	Pirogov Russian National Research Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
N.N.Blokhin Russian Cancer Research Center	Recruiting	Moscow		115478	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D012004	Rectal Neoplasms
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009074	Melanocyte-Stimulating Hormones

Ancestor Terms

ID	Term
D053486	Melanocortins
D011333	Pro-Opiomelanocortin
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided