NCT03899935

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

6.9 years

First QC Date

March 31, 2019

Last Update Submit

August 20, 2019

Conditions

EndometriosisObesity

Keywords

EndometriosisObesityLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Laparotomic conversion rate

    Intraoperative

  • Hospital length of stay

    Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.

  • Intraoperative complication rate

    Intraoperative

  • Postoperative complication rate

    Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.

Study Arms (2)

Group A: obese patients

Obese patients undergoing laparoscopic surgery for endometriosis

Procedure: Laparoscopy

Group B: non-obese patients

Non-obese patients undergoing laparoscopy for endometriosis

Procedure: Laparoscopy

Interventions

LaparoscopyPROCEDURE

Laparoscopy for endometriosis

Group A: obese patientsGroup B: non-obese patients

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Consecutive patients affected by endometriosis undergoing to laparoscopic endometriosis removal.

You may qualify if:

  • Obese patients undergoing endometriosis laparoscopic treatment
  • Obteined Informed Consensus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diego Raimondo

Bologna, BO, 40138, Italy

Location

MeSH Terms

Conditions

EndometriosisObesity

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2019

First Posted

April 2, 2019

Study Start

January 1, 2010

Primary Completion

November 30, 2016

Study Completion

December 31, 2016

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

IT(1)