Endometriosis; PeritoneumNCT05162794
Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?
A study testing Laparoscopy with excision, Laparoscopy without excision and Medical treatment-as-usual in people with Endometriosis; Peritoneum, run by University of Aarhus at 5 sites in Denmark.
Trial summary
The trial seeks to test effect of laparoscopic excision of peritoneal endometriosis on pelvic pain. Data will also be gathered on quality of life and neuropathic pain. Patients will be randomized to one of three groups: 1) laparoscopy with excision of endometrial tissue, 2) laparoscopy without excision of endometrial… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis; Peritoneum
- What is being tested?
- Laparoscopy with excision, Laparoscopy without excision and Medical treatment-as-usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesDenmark
- Study dates
- 31 Jan 2022to 1 Jul 2026
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult (≥ 18 years) with suspected peritoneal endometriosis undergoing elective surgery for pain relief
- Pain intensity ≥ 5 on Numeric Rating Scale (NRS) in the four weeks prior to giving consent
Who cannot join
- Other known conditions/diseases that may cause pelvic pain
- Diagnosed personality disorder, schizophrenia or treatment with anti-psychotics
- Planned pregnancy during study period
- Women who cannot read or speak Danish
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Aarhus University Hospital, Department of Obstetrics and Gynecology
Aarhus N, DK-8200
- Recruiting
Regional Hospital Herning, Department of Obstetrics and Gynecology
Herning, DK-7400
- Recruiting
Regional Hospital Horsens, Department of Obstetrics and Gynecology
Horsens, Central Jutland, DK-8700
- Recruiting
Regional Hospital Randers, Department of Obstetrics and Gynecology
Randers, DK-8930
- Recruiting
Regional Hospital Viborg, Department of Obstetrics and Gynecology
Viborg, DK-8800
About this study
Official title: Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful: A Double-blind, Randomized, Controlled, Three-armed Surgical Trial.
The trial seeks to test effect of laparoscopic excision of peritoneal endometriosis on pelvic pain. Data will also be gathered on quality of life and neuropathic pain. Patients will be randomized to one of three groups: 1) laparoscopy with excision of endometrial tissue, 2) laparoscopy without excision of endometrial tissue and 3) waiting list control.
- Conditions
- Endometriosis; Peritoneum
- Being tested
- Laparoscopy with excision, Laparoscopy without excision, Medical treatment-as-usual
- Keywords
- Pelvic pain, Quality of life, Post-surgical neuropathic pain, Endometriosis surgery
- 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.
Laparoscopy with excisionOther
Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. Then, the relevant tissue will be excised and a histology will be performed.
Laparoscopy without excisionOther
Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed.
Medical treatment-as-usualOther
Patients continue their hormonal and analgesic treatment-as-usual.
| Study group | Role | What they receive |
|---|---|---|
| Active Surgery | Other | Not described Receives: Other: Laparoscopy with excision; Other: Medical treatment-as-usual |
| Diagnostic Surgery | Other | Not described Receives: Other: Laparoscopy without excision; Other: Medical treatment-as-usual |
| No-surgery control | Other | Not described Receives: Other: Medical treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain measured using NRS
Pelvic pain intensity (sensory) and unpleasantness (affective) will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly.
Measured: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Secondary outcomes (6)
Health-related Quality of Life measured using Endometriosis Health Profile-30
Quality of Life will be measured using the validated and patient-generated, endometriosis-specific questionnaire "Endometriosis Health Profile 30", consisting of 30 questions rated on Likert scales.
Measured: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Neuropathic pain symptoms (patient-reported) measured using painDETECT
Neuropathic pain symptoms (patient-reported) is measured using the validated painDETECT questionnaire.
Measured: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Neuropathic pain symptoms (assessed) measured using quantitative sensory testing
Neuropathic pain symptoms (assessed) is measured using a quantitative sensory testing battery. Allodynia, pinprick and pressure pain thresholds are measured.
Measured: Change from pre-randomization to 6 months post-randomization.
Work ability measured using "Work Ability Index"
Work ability is measured using the "Work Ability Index" short questionnaire.
Measured: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Worst pelvic pain measured using NRS
Worst pelvic pain intensity and unpleasantness will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly.
Measured: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Pain frequency measured using weekly count
Pain frequency will be measured using a weekly count, ranging from 0 days of pain to 7 days of pain.
Measured: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start31 Jan 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
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 Endometriosis; PeritoneumStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital
- Responsible party
- Sponsor
- Investigators
- Axel Forman, PhD, MD, Study director, Aarhus University, Aarhus University Hospital, DenmarkHenrik Marschall, MSc, Principal investigator, University of AarhusDorthe K Thomsen, PhD, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162794
- Sponsor's protocol ID
- LAPEX
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When participant inclusion has ended, data can be shared in accordance with the ICJME guidelines, if relevant research objectives are provided. Data sharing will require approval from the Central Denmark Region and the Danish Data Protection Agency, and the requesting party shall cover any fees associated with data sharing. Requests for data can be addressed to af@clin.au.dk.
Publications
Marschall H, Forman A, Lunde SJ, Kesmodel US, Hansen KE, Vase L. Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial. BMJ Open. 2022 Nov 3;12(11):e062808. doi: 10.1136/bmjopen-2022-062808.
PubMed 36328387
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful: A Double-blind, Randomized, Controlled, Three-armed Surgical Trial.
- ClinicalTrials.gov ID
- NCT05162794
- Acronym / sponsor ID
- LAPEX
- Conditions
- Endometriosis; Peritoneum
- Keywords
- Pelvic pain, Quality of life, Post-surgical neuropathic pain, Endometriosis surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 17 Dec 2021 (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.
The trial seeks to test effect of laparoscopic excision of peritoneal endometriosis on pelvic pain. Data will also be gathered on quality of life and neuropathic pain. Patients will be randomized to one of three groups: 1) laparoscopy with excision of endometrial tissue, 2) laparoscopy without excision of endometrial tissue and 3) waiting list control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Surgery | Other | Other: Laparoscopy with excision, Other: Medical treatment-as-usual |
| Diagnostic Surgery | Other | Other: Laparoscopy without excision, Other: Medical treatment-as-usual |
| No-surgery control | Other | Other: Medical treatment-as-usual |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult (≥ 18 years) with suspected peritoneal endometriosis undergoing elective surgery for pain relief
- Pain intensity ≥ 5 on Numeric Rating Scale (NRS) in the four weeks prior to giving consent
Key exclusion criteria (4 listed)
- Other known conditions/diseases that may cause pelvic pain
- Diagnosed personality disorder, schizophrenia or treatment with anti-psychotics
- Planned pregnancy during study period
- Women who cannot read or speak Danish
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 |
|---|---|---|
| Laparoscopy with excisionDiagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. Then, the relevant tissue will be excised and a histology will be performed. | Other | Active Surgery |
| Laparoscopy without excisionDiagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed. | Other | Diagnostic Surgery |
| Medical treatment-as-usualPatients continue their hormonal and analgesic treatment-as-usual. | Other | Active Surgery, Diagnostic Surgery, No-surgery control |
Primary outcome
Pelvic pain measured using NRS
Time frame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Pelvic pain intensity (sensory) and unpleasantness (affective) will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly.
6 secondary outcomes
Health-related Quality of Life measured using Endometriosis Health Profile-30
Time frame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Neuropathic pain symptoms (patient-reported) measured using painDETECT
Time frame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Neuropathic pain symptoms (assessed) measured using quantitative sensory testing
Time frame: Change from pre-randomization to 6 months post-randomization.
Work ability measured using "Work Ability Index"
Time frame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Worst pelvic pain measured using NRS
Time frame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Pain frequency measured using weekly count
Time frame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Derived from this study: PubMed 36328387Marschall H, Forman A, Lunde SJ, Kesmodel US, Hansen KE, Vase L. Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial. BMJ Open. 2022 Nov 3;12(11):e062808. doi: 10.1136/bmjopen-2022-062808.
- Individual participant dataSharing planned: Yes. When participant inclusion has ended, data can be shared in accordance with the ICJME guidelines, if relevant research objectives are provided. Data sharing will require approval from the Central Denmark Region and the Danish Data Protection Agency, and the requesting party shall cover any fees associated with data sharing. Requests for data can be addressed to af@clin.au.dk.
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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.
Axel Forman, PhD, MD study director
Aarhus University, Aarhus University Hospital, Denmark
Henrik Marschall, MSc principal investigator
University of Aarhus
Dorthe K Thomsen, PhD study chair
University of Aarhus
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopy with excision, Laparoscopy without excision and Medical treatment-as-usual in people with Endometriosis; Peritoneum, run by University of Aarhus at 5 sites in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henrik Marschall, MSc (+4522394563, hmars@psy.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic pain measured using NRS (time frame: Change from pre-randomization to 1, 3 and 6 months post-randomization.). 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 NCT05162794, 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 15 Nov 2024.