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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03899935
Other study ID # ObesityEndometriosis
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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