Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

NCT05939687 | Recruiting Phase 3 DMC

• 1 other identifier: ProMeLAR-01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms Malignant; Rectal Cancer; Hernia Incisional; Surgery

Keywords

Rectal cancer; mesh; stoma-site hernia; prevention; surgery

Outcome Measures

Primary Outcomes (1)

• hernia rate

  The rate of parastomal hernias after stoma closure for 2 years.

  2 years

Secondary Outcomes (2)

• 90 day surgical morbidity

  90 days

• Quality of life indicators by HerQLes scale

  2 years

Study Arms (2)

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

mesh PROCEDURE

We'll use mesh repair for prevention of stoma-site hernias in the study group.

Also known as: polypropylene mesh

mesh

non-mesh PROCEDURE

We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.

non-mesh

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

N.N.Blokhin Russian Cancer Research Center

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Neoplasms; Rectal Neoplasms; Incisional Hernia

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• 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

Central Study Contacts

Sergey Gordeyev, D.Sc.

CONTACT

9104501213; ss.netoncology@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Department of Colorectal surgery

Model Details: 1:1 electronic randomisation

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: June 5, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)