NCT04062916

Brief Summary

This is a retrospective cohort study that evaluates the postoperative pain findings of a consecutive series of laparoscopic surgeries for deep infiltrating endometriosis (DIE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

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, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

6.3 years

First QC Date

August 16, 2019

Last Update Submit

August 19, 2019

Conditions

Keywords

endometriosis

Outcome Measures

Primary Outcomes (2)

  • Quality of Life after endometriosis surgery

    Effects of endometriosis surgery on the quality of life by using BSGE pelvic pain questionnaire

    7 years

  • Pain levels after endometriosis surgery

    Effects of endometriosis surgery on pelvic pain by using VAS scores

    3 years

Study Arms (1)

women with endometriosis

65 women whose main symptom was pain and who did not respond to medical treatment and underwent endometriosis surgery

Other: BSGE pelvic pain questionnaire and VAS scores

Interventions

Patients were evaluated using the BSGE pelvic pain questionnaire in terms of pre-operative and post-operative pain assessment in order to determine the effects of endometriosis surgery on the quality of life. The patients were asked to indicate their levels of dyspareunia, dysmenorrhea, and chronic pelvic pain on a VAS on the pelvic pain questionnaire.

women with endometriosis

Eligibility Criteria

Age22 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with endometriosis 65 women whose main symptom was pain and who did not respond to medical treatment and underwent endometriosis surgery

You may qualify if:

  • Patients with deep infiltration endometriosis and endometrioma diagnosed through bimanual gynecologic examination, gynecologic ultrasound or through laparoscopically confirmed endometrioma and DIE together;
  • DIE with bowel involvement that required shaving or segmental resection for colorectal lesions and nodules;
  • Who completed the VAS score and BSGE questionnaire;
  • Follow-up period of at least 3 months;
  • Patients resistant to medical therapy (NSAIDs, OCPs, levonorgestrel-releasing intrauterine device (IUD), and progesterone) or refuse to use medical therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Fulya Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ercan Bastu, MSc, MD

    Acibadem Fulya Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 20, 2019

Study Start

January 1, 2013

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations