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

NCT ID: NCT04062916

Last Updated: 2019-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

women with endometriosis

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

BSGE pelvic pain questionnaire and VAS scores

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Acibadem Fulya Hastanesi

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ercan Bastu, MSc, MD

Role: PRINCIPAL_INVESTIGATOR

Acibadem Fulya Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Acibadem Fulya Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AcibademFulyaHendo

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.