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Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias

NCT01240434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2010-11-15

No results posted yet for this study

Summary

The investigators perform a simple-blind randomized trial with two groups, one in which all the orifices are closed by suturing the external fascia of the abdominal wall (Group A), and another in which the orifices are left open, closing only the skin (Group B). Monitoring for trocar site hernia lasted 2 years from the intervention.

Conditions

  • The Aim of the Study is to Analyze the Incidence of Trocar Site Hernia (TSH)
  • in Orifices Created by Trocars Measuring ≥10 mm in Diameter,
  • and to Determine Whether Closure of the External Fascial Layer Prevents
  • TSH and Potential Related Complications.

Interventions

PROCEDURE

Trocar site closure

The study has 2 arms: one in which all the ST orifices are closed by suturing the external fascia of the abdominal wall with a number 1 monofilament absorbable suture (Polydioxanone) (Group A), and another in which all the orifices of the ST are left open, closing only the skin (Group B).

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-09-30
Completion
2008-10-31

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 NCT01240434 on ClinicalTrials.gov