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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConsorci Sanitari Integral

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Lateral colostomy or a colostomy that will be removed posteriorly

Trial design

Design model

Parallel

Treatments tested in this trial

  • Permanent colostomy

    Procedure/Surgery

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

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: IPST mesh placementExperimental treatment 1 intervention
Group B: No meshActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative parastomal hernia prevention

proportion of Postoperative parastomal hernias

Time frame
up to one year post-intervention

Secondary outcomes

1

Postoperative parastomal hernia prevention

proportion of Postoperative parastomal hernias

Time frame
5 years after surgery
2

readmissions for complications

proportion of hospital readmissions

Time frame
up to one year post-intervention
3

morbidity

Comprehensive Complication Index (CCI) 20

Time frame
up to one year post-intervention

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: