Clinical trial NCT05939687: Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
Official title: Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Neoplasms Malignant
Rectal Cancer
Hernia Incisional
Surgery
Keywords: Rectal cancer
mesh
stoma-site hernia
prevention
surgery
Lead sponsor: Blokhin's Russian Cancer Research Center
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 electronic randomisation
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: hernia rate
timeFrame: 2 years
Secondary outcomes:
measure: 90 day surgical morbidity
timeFrame: 90 days
measure: Quality of life indicators by HerQLes scale
timeFrame: 2 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: N.N.Blokhin Russian Cancer Research Center
Study officials:
affiliation: N.N.Blokhin Russian Cancer Research Center
name: Zaman Z Mamedli, PhD
role: STUDY_DIRECTOR
affiliation: Pirogov Russian National Research Medical University
name: Nikolay L Matveev, PhD
role: STUDY_CHAIR
References: