CClinicalTrials.gg
Status unknownNCT03953365Updated May 16, 2019

Prophylactic Mesh in Cytoreductive Surgery

An interventional study of Prophylactic Mesh in Incisional Hernia, sponsored by Hospital Universitario Fundación Alcorcón. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-16.

Sponsored by Hospital Universitario Fundación Alcorcón · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.

Read the detailed description

Based on the hypothesis that oncological cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) is associated with an increased risk of developing Incisional Hernia in the postoperative period, with an expected incidence of 50% at 24 months, we designed a prospective, multicenter and randomized clinical study to demonstrate the utility of the meshes in the prevention of Incisional Hernia, hoping to reduce the incidence to 15% at 24 months.

02

Conditions studied

  • Incisional Hernia

Keywords

  • hyperthermic intraperitoneal chemotherapy
  • cytoreduction surgery
  • prophylactic mesh
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In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's planned enrollment of 66 is below the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Hospital Universitario Fundación Alcorcón is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Completeness of cytoreduction after surgery (CC-SCORE) CC-0, CC-1

Exclusion criteria

Exclusion Criteria:

  • Completeness of cytoreduction after surgery (CC-SCORE) CC-2, CC-3
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
66 participants (estimated)

Study arms

  • No intervention
    without mesh

    Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy without prophylactic mesh

  • Other
    with mesh

    Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with prophylactic mesh

    Procedure: Prophylactic Mesh

Interventions

  • ProcedureProphylactic Mesh

    Prophylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

06

What researchers measure

Primary outcomes

  1. Rate of Incisional Hernia

    Prevention of Incisional Hernia

    Time frame: four years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03953365
Lead sponsor
Hospital Universitario Fundación Alcorcón
Responsible party
Federico Ochando (MEDICAL DOCTOR, Hospital Universitario Fundación Alcorcón) — Principal investigator
First posted
May 16, 2019
Start date
Jun 1, 2019 (estimated)
Primary completion
May 31, 2021 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
May 16, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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