Laparoscopy for Endometriosis in Obese Patients

Completed

• Conditions: Endometriosis; Obesity
• Interventions: Procedure: Laparoscopy

• Registration Number: NCT03899935
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

Evaluation of surgical outcomes of endometriosis laparoscopic surgery in obese patients.

Detailed Description

Obesity may influence surgical variables such as operative time, laparotomic conversion rate and intraoperative and postoperative complication rate. Moreover, it might influence the hospital length of stay. For that reason, the study aims to compare a group of obese patients with a non-obese group of patients about these topics.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2016-11-30
• Study Completion: 2016-12-31
• Study First Submitted: 2019-03-31
• Study First Submitted QC: 2019-03-31
• Study First Posted: 2019-04-02
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1230

Inclusion Criteria

• Obese patients undergoing endometriosis laparoscopic treatment
• Obteined Informed Consensus

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: obese patients	Laparoscopy	Obese patients undergoing laparoscopic surgery for endometriosis
Group B: non-obese patients	Laparoscopy	Non-obese patients undergoing laparoscopy for endometriosis

Primary Outcome Measures

Name	Time	Method
Operative time	Intraoperative: from the skin incision to the skin suture	Comparison of operative time, expressed in minutes, between Group A and Group B

Secondary Outcome Measures

Name	Time	Method
Laparotomic conversion rate	Intraoperative	Comparison of laparotomic conversion rate between Group A and Group B
Hospital length of stay	Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.	Comparison of hospital length of stay, expressed in days, between Group A and Group B
Postoperative complication rate	Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.	Comparison of postoperative complication rate between Group A and Group B. Postoperative complication rate is assessed using Clavien-Dindo Classification (from grade I to V, where I means any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions, and V means the death of a patient)
Intraoperative complication rate	Intraoperative	Comparison of intraoperative complication rate between Group A and Group B. Intraoperative complication rate is assessed using Clavien-Dindo Classification (from grade I to V, where I means any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions, and V means the death of a patient)

Trial Locations

Locations (1)

Diego Raimondo; 🇮🇹 Bologna, BO, Italy