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Completed

NCT Number: NCT04081532

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Screening

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

Secondary outcomes

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

    Time frame: Screening

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

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

    Time frame: visit 2 (day of surgery)

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

  3. Effects of treatment and variability in treatment outcomes

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

    Intraoperative and postoperative complications

  4. Improvement in quality of life

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

    Endometriosis Health Profile-30 (EHP-30)

  5. Improvement in quality of life

    Time frame: day of surgery, follow up at 3 and 6 months

    Rome IV criteria

  6. Improvement in quality of life

    Time frame: day of surgery, follow up at 3 and 6 months

    Pelvic Pain and Urgency/Frequency Patient (PUF) Symptom Scale

  7. Improvement in quality of life

    Time frame: day of surgery, follow up at 3 and 6 months

    PainDetect TM

  8. Improvement in quality of life

    Time frame: day of surgery, follow up at 3 and 6 months

    Brief Fatigue Inventory (BFI)

  9. Improvement in quality of life

    Time frame: day of surgery, follow up at 3 and 6 months

    Pain Catastrophising Questionnaire (PCQ)

  10. Improvement in quality of life

    Time frame: day of surgery, follow up at 3 and 6 months

    Fibromyalgia Scale

  11. Improvement in quality of life

    Time frame: day of surgery, follow up at 3 and 6 months

    Measure Yourself Medical Outcome Profile 2 (MYMOP 2)

  12. Improvement in quality of life

    Time frame: day of surgery, follow up at 3 and 6 months

    Working Productivity and Activity Impairment Questionnaire (WPAIQ)

  13. Improvement in quality of life

    Time frame: day of surgery, follow up at 3 and 6 months

    EuroQol 5 Dimensions 5 Level Questionnaire (EQ-5D-5L)

  14. Effects of treatment and variability in treatment outcomes

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

    Number of patients who needed analgesia after laparoscopy recorded during follow up.

  15. Effects of treatment and variability in treatment outcomes

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

    Number of patients who needed medical management with ovarian suppression after laparoscopy recorded during follow up.

  16. Effects of treatment and variability in treatment outcomes

    Time frame: Throughout the trial starting from day of surgery until end of followup at 6 months

    Adverse events (as reported by the participants)

  17. To determine the most acceptable methods of recruitment and assessment tools

    Time frame: Questionnaires collected at Baseline (within a week of surgery), 3 and 6 months follow up

    The proportion of completed trial questionnaires

  18. To determine the most acceptable methods of assessment tools

    Time frame: Throughout the trial until end of follow up at 6 months

    Number of patients who remained blinded for 6 months after the surgery recorded by asking patient if they were told their allocation

  19. To determine the most acceptable methods of recruitment, randomisation and assessment tools

    Time frame: 6 months follow up

    Acceptability of the trial completed at 6 months after surgery will be compared between two arms.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Grampian
  • University of Nottingham

Registry information

Official study title

The Effectiveness of Laparoscopic Treatment of Isolated Superficial Peritoneal Endometriosis for Managing Chronic Pelvic Pain in Women: a Randomised Controlled Feasibility Trial

Acronym: ESPriT1

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2019
Registry last updated
Jun 13, 2024

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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