NCT01240434View on ClinicalTrials.gov

Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias

NACompletedINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

September 30, 2007

Study Completion Date

October 31, 2008

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 PreventsTSH 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).

Trial Locations (1)

28007

Hospital General Universitario Gregorio Marañón, Madrid

All Listed Sponsors
lead

Hospital General Universitario Gregorio Marañon

OTHER

NCT01240434 - Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias | Biotech Hunter | Biotech Hunter