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

NCT04081532 | Completed

• 1 other identifier: AC19062
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis; Pelvic Pain

Keywords

endometriosis; laparoscopy; pelvic pain

Outcome Measures

Primary Outcomes (1)

• 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

  Screening

Secondary Outcomes (19)

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

  Screening

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

  visit 2 (day of surgery)

• Effects of treatment and variability in treatment outcomes

  visit 2 (day of surgery), 30 days post surgery

• Improvement in quality of life

  30 days post surgery, follow up at 3 and 6 months

• Improvement in quality of life

  day of surgery, follow up at 3 and 6 months

Study Arms (2)

Surgical treatment

ACTIVE COMPARATOR

Procedure: surgical removal of superficial peritoneal endometriosis

No surgical treatment

NO INTERVENTION

Interventions

surgical removal of superficial peritoneal endometriosis PROCEDURE

In the active comparator group patients will have endometriosis lesions removed by ablation or excision. Patients randomised to no surgical treatment arm will not have lesions removed and will only be given diagnosis on whether endometriosis was found or not.

Surgical treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Grampian: collaborator
• University of Nottingham: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (1)

• Whitaker LHR, Doust A, Stephen J, Norrie J, Cooper K, Daniels J, Hummelshoj L, Cox E, Beatty L, Chien P, Madhra M, Vincent K, Horne AW. Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: study protocol for a randomised controlled feasibility trial (ESPriT1). Pilot Feasibility Stud. 2021 Jan 7;7(1):19. doi: 10.1186/s40814-020-00740-9.

  PMID: 33413677 DERIVED

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew W Horne, Prof

  University of Edinburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: General Practitioner
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: September 9, 2019
• Study Start: September 30, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

GB (1)