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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062916
• Other study ID #: AcibademFulyaHendo
• Status: Completed
• Start date: January 2013
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: Acibadem Fulya Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Acibadem Fulya Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem Fulya Hastanesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life after endometriosis surgery	Effects of endometriosis surgery on the quality of life by using BSGE pelvic pain questionnaire	7 years
Primary	Pain levels after endometriosis surgery	Effects of endometriosis surgery on pelvic pain by using VAS scores	3 years