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Laparoscopy for Endometriosis in Obese Patients

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ClinicalTrials.gov Identifier: NCT03899935
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Renato Seracchioli, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Brief Summary:
Evaluation of surgical outcomes of endometriosis laparoscopic surgery in obese patients.

Condition or disease Intervention/treatment
Endometriosis Obesity Procedure: Laparoscopy

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.

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Study Type : Observational
Actual Enrollment : 1230 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Feasibility and Safety of Endometriosis Laparoscopic Removal in Obese Patients: a Propensity Score Method Analysis
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort Intervention/treatment
Group A: obese patients
Obese patients undergoing laparoscopic surgery for endometriosis
Procedure: Laparoscopy
Laparoscopy for endometriosis

Group B: non-obese patients
Non-obese patients undergoing laparoscopy for endometriosis
Procedure: Laparoscopy
Laparoscopy for endometriosis




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Laparotomic conversion rate [ Time Frame: Intraoperative ]
    Comparison of laparotomic conversion rate between Group A and Group B

  2. 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

  3. 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)

  4. 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)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients affected by endometriosis undergoing to laparoscopic endometriosis removal.
Criteria

Inclusion Criteria:

  • Obese patients undergoing endometriosis laparoscopic treatment
  • Obteined Informed Consensus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899935


Locations
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Italy
Diego Raimondo
Bologna, BO, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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Responsible Party: Renato Seracchioli, Principal Investigator, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03899935     History of Changes
Other Study ID Numbers: ObesityEndometriosis
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Renato Seracchioli, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Endometriosis
Obesity
Laparoscopy

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female