Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh

NCT ID: NCT06533839

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2029-08-01

Brief Summary

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Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. A noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. The clinical manifestations of PH are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia.

Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes.

The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.

Detailed Description

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Conditions

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Parastomal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicentric randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single blinded

Study Groups

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IPST mesh placement

A three-dimensional, funnel-shaped mesh will be used.

Group Type EXPERIMENTAL

Permanent colostomy

Intervention Type PROCEDURE

A long-term (permanent) colostomy will be performed in the diseased colon or rectum.

No mesh

No mesh will be applied.

Group Type ACTIVE_COMPARATOR

Permanent colostomy

Intervention Type PROCEDURE

A long-term (permanent) colostomy will be performed in the diseased colon or rectum.

Interventions

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Permanent colostomy

A long-term (permanent) colostomy will be performed in the diseased colon or rectum.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing a definitive colostomy confection
* Terminal colostomy confection
* ASA index III or inferior
* Patients who have given legat authorization to participate in the study

Exclusion Criteria

* Lateral colostomy or a colostomy that will be removed posteriorly
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari Integral

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Sant Joan Despí Moisès Broggi

Sant Joan Despí, Barcelona, Spain

Site Status

Countries

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Spain

Central Contacts

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Laura Sobrerroca Porras, MD

Role: CONTACT

+34935531200

Facility Contacts

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Laura Sobrerroca Porras, MD

Role: primary

Jesús Badia Closa

Role: backup

Other Identifiers

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24/20

Identifier Type: -

Identifier Source: org_study_id

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