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NCT Number: NCT06533839

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan Despí Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

Location contact

Jesús Badia Closa

CONTACT

[email protected]

Laura Sobrerroca Porras, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Permanent colostomy

Procedure

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

Primary outcomes

  1. Postoperative parastomal hernia prevention

    Time frame: up to one year post-intervention

    proportion of Postoperative parastomal hernias

Secondary outcomes

  1. Postoperative parastomal hernia prevention

    Time frame: 5 years after surgery

    proportion of Postoperative parastomal hernias

  2. readmissions for complications

    Time frame: up to one year post-intervention

    proportion of hospital readmissions

  3. morbidity

    Time frame: up to one year post-intervention

    Comprehensive Complication Index (CCI) 20

Study contacts

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

Laura Sobrerroca Porras, MD

CONTACT

[email protected]

+34935531200

Sponsors and collaborators

Lead sponsor

Consorci Sanitari Integral

Other

Registry information

Official study title

Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh. A Prospective, Multicenter and Randomized Study (PREVEMAC)

Acronym: PREVEMAC

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Aug 1, 2024
Registry last updated
Aug 1, 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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