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Completed

NCT Number: NCT04062916

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

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

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Key information

Age range

22 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Acibadem Fulya Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BSGE pelvic pain questionnaire and VAS scores

Other

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.

Primary outcomes

  1. Quality of Life after endometriosis surgery

    Time frame: 7 years

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

  2. Pain levels after endometriosis surgery

    Time frame: 3 years

    Effects of endometriosis surgery on pelvic pain by using VAS scores

Sponsors and collaborators

Lead sponsor

Acibadem Fulya Hastanesi

Network

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2019
Registry last updated
Aug 20, 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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