Laparoscopy for Endometriosis in Obese Patients

Obesity Clinical Trial

Official title:

Feasibility and Safety of Endometriosis Laparoscopic Removal in Obese Patients: a Propensity Score Method Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03899935
• Other study ID #: ObesityEndometriosis
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: December 31, 2016

Study information

• Verified date: August 2019
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1230
• Est. completion date: December 31, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Obese patients undergoing endometriosis laparoscopic treatment

• Obteined Informed Consensus

Related Conditions & MeSH terms

• Endometriosis
• Obesity

Intervention

Procedure:
• Laparoscopy
Laparoscopy for endometriosis

Locations

Country	Name	City	State
Italy	Diego Raimondo	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Comparison of operative time, expressed in minutes, between Group A and Group B	Intraoperative: from the skin incision to the skin suture
Secondary	Laparotomic conversion rate	Comparison of laparotomic conversion rate between Group A and Group B	Intraoperative
Secondary	Hospital length of stay	Comparison of hospital length of stay, expressed in days, between Group A and Group B	Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.
Secondary	Intraoperative complication rate	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)	Intraoperative
Secondary	Postoperative complication rate	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)	Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.