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The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain (ESPriT1)

U

University of Edinburgh

Status

Completed

Conditions

Pelvic Pain
Endometriosis

Treatments

Procedure: surgical removal of superficial peritoneal endometriosis

Study type

Interventional

Funder types

Other

Identifiers

NCT04081532
AC19062

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Undergoing laparoscopy for the investigation of chronic pelvic pain
  • In order to be randomised, isolated superficial peritoneal endometriosis (SPE) must be identified at laparoscopy (macroscopically)
  • Able to give informed consent

Exclusion criteria

  • Previous surgical diagnosis of endometriosis
  • Pregnant or are actively trying for pregnancy within the next six months
  • Deep endometriosis or ovarian endometrioma on imaging or at laparoscopy
  • Peritoneal 'pockets' only noted at laparoscopy

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

7 participants in 2 patient groups

Surgical treatment
Active Comparator group
Treatment:
Procedure: surgical removal of superficial peritoneal endometriosis
No surgical treatment
No Intervention group

Trial contacts and locations

1

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Central trial contact

Ann M Doust; Magda Koscielniak, PhD

Data sourced from clinicaltrials.gov

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