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

NCT06533839 | Not Yet Recruiting

• 1 other identifier: 24/20
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parastomal Hernia

Keywords

Parastomal hernia; end colostomy; prophylactic mesh

Outcome Measures

Primary Outcomes (1)

• Postoperative parastomal hernia prevention

  proportion of Postoperative parastomal hernias

  up to one year post-intervention

Secondary Outcomes (3)

• Postoperative parastomal hernia prevention

  5 years after surgery

• readmissions for complications

  up to one year post-intervention

• morbidity

  up to one year post-intervention

Study Arms (2)

IPST mesh placement

EXPERIMENTAL

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

Procedure: Permanent colostomy

No mesh

ACTIVE COMPARATOR

No mesh will be applied.

Procedure: Permanent colostomy

Interventions

Permanent colostomy PROCEDURE

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

IPST mesh placement; No mesh

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Lateral colostomy or a colostomy that will be removed posteriorly

Sponsors & Collaborators

• Consorci Sanitari Integral: lead

Study Sites (1)

Hospital Sant Joan Despí Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

Location

Central Study Contacts

Laura Sobrerroca Porras, MD

CONTACT

+34935531200; lsobrerrocap@csi.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentric randomised controlled trial

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)