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Trocar Site Incisional Hernia Prevention

NCT04699201 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-10-02

No results posted yet for this study

Summary

Objective: To test the preventive effect of the placement of an onlay mesh versus the use of a fascial closure device at the umbilical trocar site closure in order to prevent incisional hernia after laparoscopic surgery.

Methods: We designed a Two Center Randomized Controlled Trial were adult participants presenting for elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct will be recruited, with allocation of each of them in 2 groups (prosthesis and control). Abdominal ultrasound scan focused on aponeurosis defects at the trocar sites will be performed at 12 postoperative months.

An ultrasound scan will be performed to avoid underdiagnosis bias since incisional hernia is frequently under detected by clinical examination.

Relevance: The prevalence of incisional hernia after laparoscopy might be as high as 30%, due to this reason is paramount to find a better closure technique.

There are few studies about incisional hernia including radiological exams in order to provide the exact prevalence of this pathology, even fewer literature exists about incisional hernia after laparoscopic procedures.

Conditions

  • Incisional Hernia

Interventions

PROCEDURE

Hincisional hernia prevention by onlay prosthesis trocar closure

Hincisional hernia prevention by onlay prosthesis trocar closure

PROCEDURE

laparoscopic cholecystectomy

Laparoscopic cholecystectomy with or without common bile duct exploration

DIAGNOSTIC_TEST

Abdominal ultrasound

Ultrasound focused in abdominal wall defects on the trocar incisions, 12 months after the surgery

Sponsors & Collaborators

  • Institut de Diagnostic per la Imatge

    collaborator OTHER

  • Institut Investigacio Sanitaria Pere Virgili

    collaborator OTHER

  • Hospital Universitari Joan XXIII de Tarragona.

    lead OTHER

Principal Investigators

  • Carles Olona Casas, MD · Hospital Universitari de Tarragona

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2024-11-30
Completion
2025-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04699201 on ClinicalTrials.gov