The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain

University of Edinburgh7 enrolled

Overview

Endometriosis is a chronic, incurable condition that affects about 10% of women of reproductive age. It is defined as a growth of cells similar to the womb lining outside of the womb in the pelvis, and is associated with chronic pelvic pain, excessive period pain, pain with sexual intercourse and difficulties in getting pregnant. If the disease is found only on the lining of the pelvis it is known as "superficial peritoneal" and is usually treated during a laparoscopic surgery by cutting out (excision) or burning off (ablation). However, many women do not find improvement in their symptoms after the surgery and can have complications from the procedure. The aim of this study is to determine if removal of the superficial peritoneal endometriosis improves pain symptoms and quality of life, which method of removal (excision or ablation) is more effective or if surgical removal is of no benefit to the patients and can potentially cause harm. The investigators plan to recruit up to 90 women from four NHS hospitals in Scotland over a period of 12 months. Women who are attending gynaecology departments with pelvic pain who have not previously had a diagnosis of endometriosis via laparoscopy will be approached. Patients will be asked to read an information sheet about the trial. Women who consent to the trial will be randomised during the surgery, if superficial endometriosis is found, to either having the endometriosis removed or not. For this pilot, follow up will be at 3 and 6 months (and obtain permission to continue to follow them up at 12 and 24 months should time and finding permit). Patients who do not consent to take part in the trial will be asked if the investigators can collect data on their demographics and reasons on why they did not wish to take part.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Outcomes

Primary Outcomes

Proportion of women with suspected SPE undergoing diagnostic laparoscopy that were approached for the study an agreed to randomisation

The proportion of screened women who are eligible for the trial determined from the screening logs

Time frame: Screening

Secondary Outcomes

Baseline characteristics of eligible women that agree to be randomised and those that decline participation

Baseline characteristics including age, social deprivation, ethnicity and duration of pain collected from screened women

Time frame: Screening

Proportion of women having laparoscopy for investigation of chronic pelvic pain that are eligible (i.e. have only SPE) for the trial

The proportion of women undergoing diagnostic laparoscopy who go on to be diagnosed with SPE

Time frame: visit 2 (day of surgery)

Effects of treatment and variability in treatment outcomes

Intraoperative and postoperative complications

Time frame: visit 2 (day of surgery), 30 days post surgery