Improvement in Quality of Life and Pain Scores After Laparoscopic Management of Deep Infiltrating Endometriosis

Sponsor
Acibadem Fulya Hastanesi (Other)
Overall Status
Completed
CT.gov ID
NCT04062916
Collaborator
(none)
65
1
76.9
0.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: BSGE pelvic pain questionnaire and VAS scores

Detailed Description

The study was carried out in university hospitals (Istanbul, Turkey). Patients diagnosed through bimanual gynecologic examination, gynecologic ultrasound or magnetic resonance imaging-confirmed endometrioma and DIE together; who underwent a laparoscopic surgery by a team of gynecologists, colorectal surgeons, and a urologist were retrospectively evaluated. The data were collected in a specific database and analyzed for postoperative pain outcomes through a comparison with preoperative symptoms scored using a visual analogue score (VAS), and the British Society of Gynecologic Endoscopy (BSGE) pelvic pain questionnaire.

Study Design

Study Type:
Observational
Actual Enrollment :
65 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Improvement in Quality of Life and Pain Scores After Laparoscopic Management of Deep Infiltrating Endometriosis
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. Quality of Life after endometriosis surgery [7 years]

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

  2. Pain levels after endometriosis surgery [3 years]

    Effects of endometriosis surgery on pelvic pain by using VAS scores

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:

*Any other endometriosis patient that do no meet the inclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Acibadem Fulya Hospital Istanbul Turkey

Sponsors and Collaborators

  • Acibadem Fulya Hastanesi

Investigators

  • Principal Investigator: Ercan Bastu, MSc, MD, Acibadem Fulya Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Acibadem Fulya Hastanesi
ClinicalTrials.gov Identifier:
NCT04062916
Other Study ID Numbers:
  • AcibademFulyaHendo
First Posted:
Aug 20, 2019
Last Update Posted:
Aug 20, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Acibadem Fulya Hastanesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 20, 2019