Health TrialsbyHealthPanel

Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

ConditionsNeoplasms MalignantRectal CancerHernia IncisionalSurgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBlokhin's Russian Cancer Research Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent

Absence of distant metastases (M0)

ECOG (Eastern Cooperative Oncology Group) status 0-2

completed course of adjuvant treatment

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • mesh

    Procedure/Surgery

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

  • non-mesh

    Procedure/Surgery

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

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: meshExperimental treatment 1 intervention
Group B: non-meshActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

hernia rate

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

Time frame
2 years

Secondary outcomes

1

90 day surgical morbidity

Complications after stoma closure including hernias

Time frame
90 days
2

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)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Blokhin's Russian Cancer Research Center

Lead sponsor

Source ClinicalTrials.gov
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