Laparoscopy for Endometriosis in Obese Patients
August 20, 2019 updated by: Renato Seracchioli, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Feasibility and Safety of Endometriosis Laparoscopic Removal in Obese Patients: a Propensity Score Method Analysis
Evaluation of surgical outcomes of endometriosis laparoscopic surgery in obese patients.
Study Overview
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 Type
Observational
Enrollment (Actual)
1230
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BO
-
Bologna, BO, Italy, 40138
- Diego Raimondo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Consecutive patients affected by endometriosis undergoing to laparoscopic endometriosis removal.
Description
Inclusion Criteria:
- Obese patients undergoing endometriosis laparoscopic treatment
- Obteined Informed Consensus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A: obese patients
Obese patients undergoing laparoscopic surgery for endometriosis
|
Laparoscopy for endometriosis
|
|
Group B: non-obese patients
Non-obese patients undergoing laparoscopy for endometriosis
|
Laparoscopy for endometriosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operative time
Time Frame: Intraoperative: from the skin incision to the skin suture
|
Comparison of operative time, expressed in minutes, between Group A and Group B
|
Intraoperative: from the skin incision to the skin suture
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Laparotomic conversion rate
Time Frame: Intraoperative
|
Comparison of laparotomic conversion rate between Group A and Group B
|
Intraoperative
|
|
Hospital length of stay
Time Frame: 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: from surgery to hospitalization discharge, assessed up to 30 days after surgery.
|
|
Intraoperative complication rate
Time Frame: 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)
|
Intraoperative
|
|
Postoperative complication rate
Time Frame: 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)
|
Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
November 30, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
March 31, 2019
First Submitted That Met QC Criteria
March 31, 2019
First Posted (Actual)
April 2, 2019
Study Record Updates
Last Update Posted (Actual)
August 21, 2019
Last Update Submitted That Met QC Criteria
August 20, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ObesityEndometriosis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.