Status:
COMPLETED
Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias
Lead Sponsor:
Hospital General Universitario Gregorio Marañon
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,
Eligibility:
All Genders
Phase:
NA
Brief 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 whic...
Detailed Description
This is a single-blind trial including all patients undergoing laparoscopic surgery performed by the same surgical team (5 surgeons) and for whom at least one "study trocar" (ST) id use. STs is define...
Eligibility Criteria
Inclusion
- All the patients undergoing laparoscopic surgery performed by the same surgical team (5 surgeons) and for whom at least one "study trocar" (ST) is used. STs is defined as blunt-tip trocars that are inserted blind, had a diameter of 11 mm or 12 mm, and are not enlarged during surgery.
Exclusion
- Hasson trocar Patients presenting factors that affect the scarring process, such as malnutrition (serum proteins \<5 g/dl), advanced cancer, perioperative hemodynamic instability, or prolonged treatment with corticosteroids. Orifices that are enlarged for specimen extraction are also excluded, although other orifices in the same patient are included.
- Patients who are converted to open surgery. Patients who did not have an ST after surgery (mostly patients with only one ST that had to be enlarged for specimen extraction) were excluded from the trial.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT01240434
Start Date
March 1 2006
End Date
October 1 2008
Last Update
November 15 2010
Active Locations (1)
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1
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007