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OpenTrials
Completed

NCT Number: NCT03899935

Laparoscopy for Endometriosis in Obese Patients

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

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Key information

Conditions

Endometriosis Body Weight Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Diego Raimondo

Bologna, BO, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese patients undergoing endometriosis laparoscopic treatment
  • Obteined Informed Consensus

Treatment and study plan

Laparoscopy

Procedure

Laparoscopy for endometriosis

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Apr 2, 2019
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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