Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2026-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometriosis; Peritoneum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Surgery

Group Type OTHER

Laparoscopy with excision

Intervention Type OTHER

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.

Medical treatment-as-usual

Intervention Type OTHER

Patients continue their hormonal and analgesic treatment-as-usual.

Diagnostic Surgery

Group Type OTHER

Laparoscopy without excision

Intervention Type OTHER

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-usual

Intervention Type OTHER

Patients continue their hormonal and analgesic treatment-as-usual.

No-surgery control

Group Type OTHER

Medical treatment-as-usual

Intervention Type OTHER

Patients continue their hormonal and analgesic treatment-as-usual.

Interventions

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Laparoscopy with excision

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.

Intervention Type OTHER

Laparoscopy without excision

Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed.

Intervention Type OTHER

Medical treatment-as-usual

Patients continue their hormonal and analgesic treatment-as-usual.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No