EndometriosisESPriT1NCT04081532
The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain
A study testing surgical removal of superficial peritoneal endometriosis in people with Endometriosis and Pelvic Pain, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis, Pelvic Pain
- What is being tested?
- surgical removal of superficial peritoneal endometriosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2019to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Laparoscopic Treatment of Isolated Superficial Peritoneal Endometriosis for Managing Chronic Pelvic Pain in Women: a Randomised Controlled Feasibility Trial
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
- Being tested
- surgical removal of superficial peritoneal endometriosis
- Keywords
- endometriosis, laparoscopy, pelvic pain
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical removal of superficial peritoneal endometriosisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Active comparator | Not described Receives: Procedure: surgical removal of superficial peritoneal endometriosis |
| No surgical treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Screening
Secondary outcomes (19)
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
Measured: 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
Measured: visit 2 (day of surgery)
Effects of treatment and variability in treatment outcomes
Intraoperative and postoperative complications
Measured: visit 2 (day of surgery), 30 days post surgery
Improvement in quality of life
Endometriosis Health Profile-30 (EHP-30)
Measured: 30 days post surgery, follow up at 3 and 6 months
Improvement in quality of life
Rome IV criteria
Measured: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Pelvic Pain and Urgency/Frequency Patient (PUF) Symptom Scale
Measured: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
PainDetect TM
Measured: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Brief Fatigue Inventory (BFI)
Measured: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Pain Catastrophising Questionnaire (PCQ)
Measured: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Fibromyalgia Scale
Measured: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Measure Yourself Medical Outcome Profile 2 (MYMOP 2)
Measured: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Working Productivity and Activity Impairment Questionnaire (WPAIQ)
Measured: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
EuroQol 5 Dimensions 5 Level Questionnaire (EQ-5D-5L)
Measured: day of surgery, follow up at 3 and 6 months
Effects of treatment and variability in treatment outcomes
Number of patients who needed analgesia after laparoscopy recorded during follow up.
Measured: 30 days post surgery, follow up at 3 and 6 months
Effects of treatment and variability in treatment outcomes
Number of patients who needed medical management with ovarian suppression after laparoscopy recorded during follow up.
Measured: 30 days post surgery, follow up at 3 and 6 months
Effects of treatment and variability in treatment outcomes
Adverse events (as reported by the participants)
Measured: Throughout the trial starting from day of surgery until end of followup at 6 months
To determine the most acceptable methods of recruitment and assessment tools
The proportion of completed trial questionnaires
Measured: Questionnaires collected at Baseline (within a week of surgery), 3 and 6 months follow up
To determine the most acceptable methods of assessment tools
Number of patients who remained blinded for 6 months after the surgery recorded by asking patient if they were told their allocation
Measured: Throughout the trial until end of follow up at 6 months
To determine the most acceptable methods of recruitment, randomisation and assessment tools
Acceptability of the trial completed at 6 months after surgery will be compared between two arms.
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start30 Sep 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian, University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Andrew W Horne, Prof, Study chair, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081532
- Sponsor's protocol ID
- AC19062
- Acronym
- ESPriT1
- Status last verified
- Jun 2024
- First submitted
- 15 Aug 2019
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33413677
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Laparoscopic Treatment of Isolated Superficial Peritoneal Endometriosis for Managing Chronic Pelvic Pain in Women: a Randomised Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT04081532
- Acronym / sponsor ID
- ESPriT1 / AC19062
- Conditions
- Endometriosis, Pelvic Pain
- Keywords
- endometriosis, laparoscopy, pelvic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Grampian, University of Nottingham
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Active comparator | Procedure: surgical removal of superficial peritoneal endometriosis |
| No surgical treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical removal of superficial peritoneal endometriosisIn 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. | Procedure or surgery | Surgical treatment |
Primary outcome
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
19 secondary outcomes
Baseline characteristics of eligible women that agree to be randomised and those that decline participation
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
Time frame: visit 2 (day of surgery)
Effects of treatment and variability in treatment outcomes
Time frame: visit 2 (day of surgery), 30 days post surgery
Improvement in quality of life
Time frame: 30 days post surgery, follow up at 3 and 6 months
Improvement in quality of life
Time frame: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Time frame: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Time frame: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Time frame: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Time frame: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Time frame: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Time frame: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Time frame: day of surgery, follow up at 3 and 6 months
Improvement in quality of life
Time frame: day of surgery, follow up at 3 and 6 months
Effects of treatment and variability in treatment outcomes
Time frame: 30 days post surgery, follow up at 3 and 6 months
Effects of treatment and variability in treatment outcomes
Time frame: 30 days post surgery, follow up at 3 and 6 months
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
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
To determine the most acceptable methods of assessment tools
Time frame: Throughout the trial until end of follow up at 6 months
To determine the most acceptable methods of recruitment, randomisation and assessment tools
Time frame: 6 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 33413677Whitaker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew W Horne, Prof study chair
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical removal of superficial peritoneal endometriosis in people with Endometriosis and Pelvic Pain, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women with suspected SPE undergoing diagnostic laparoscopy that were approached for the study an agreed to randomisation (time frame: Screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.