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NCT Number: NCT05939687

Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

N.N.Blokhin Russian Cancer Research Center

Moscow, 115478, Russia

Location status: Recruiting

Location contact

Sergey S Gordeyev, PhD

CONTACT

[email protected]

9104501213 ext. 007

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mesh

Procedure

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

Other names: polypropylene mesh

non-mesh

Procedure

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

Primary outcomes

  1. hernia rate

    Time frame: 2 years

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

Secondary outcomes

  1. 90 day surgical morbidity

    Time frame: 90 days

    Complications after stoma closure including hernias

  2. Quality of life indicators by HerQLes scale

    Time frame: 2 years

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sergey Gordeyev, D.Sc.

CONTACT

[email protected]

9104501213 ext. 007

Sponsors and collaborators

Lead sponsor

Blokhin's Russian Cancer Research Center

Other

Registry information

Official study title

Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial

Acronym: ProMeLAR

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 11, 2023
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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