Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial
Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial
Background: endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain.
Methods: we plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons' preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants' preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at 12 months. Assuming a standard deviation of 22 points around the pain score, 90% power, 5% significance and 20% missing data, 400 participants are required to be randomised to detect an 8-point pain score difference.
Discussion: this trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE.
Trial registration: ISRCTN registry ISRCTN27244948. Registered 6 April 2021.
Endometriosis, Laparoscopy, Pelvic pain, Randomised controlled trial, Surgical ablation, Surgical excision
Mackenzie, Scott C.
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Stephen, Jacqueline
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Williams, Linda
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Daniels, Jane
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Norrie, John
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Becker, Christian M.
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Byrne, Dominic
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Cheong, Ying
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Clark, T. Justin
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Cooper, Kevin G
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Cox, Emma
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Doust, Ann M.
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Fernandez, Priscilla
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Hawe, Jeremy
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Holland, Tom
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Hummelshoj, Lone
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Jackson, Louise J.
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King, Kathleen
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Maheshwari, Abha
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Martin, Dan C.
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Sutherland, Lauren
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Thornton, Jim
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Vincent, Katy
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Vyas, Sanjay
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Horne, Andrew W.
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Whitaker, Lucy H.R.
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22 June 2023
Mackenzie, Scott C.
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Stephen, Jacqueline
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Williams, Linda
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Daniels, Jane
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Norrie, John
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Becker, Christian M.
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Byrne, Dominic
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Cheong, Ying
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Clark, T. Justin
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Cooper, Kevin G
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Cox, Emma
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Doust, Ann M.
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Fernandez, Priscilla
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Hawe, Jeremy
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Holland, Tom
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Hummelshoj, Lone
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Jackson, Louise J.
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King, Kathleen
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Maheshwari, Abha
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Martin, Dan C.
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Sutherland, Lauren
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Thornton, Jim
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Vincent, Katy
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Vyas, Sanjay
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Horne, Andrew W.
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Whitaker, Lucy H.R.
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Mackenzie, Scott C., Stephen, Jacqueline, Williams, Linda, Daniels, Jane, Norrie, John, Becker, Christian M., Byrne, Dominic, Cheong, Ying, Clark, T. Justin, Cooper, Kevin G, Cox, Emma, Doust, Ann M., Fernandez, Priscilla, Hawe, Jeremy, Holland, Tom, Hummelshoj, Lone, Jackson, Louise J., King, Kathleen, Maheshwari, Abha, Martin, Dan C., Sutherland, Lauren, Thornton, Jim, Vincent, Katy, Vyas, Sanjay, Horne, Andrew W. and Whitaker, Lucy H.R.
(2023)
Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial.
Trials, 24 (1), [425].
(doi:10.1186/s13063-023-07386-x).
Abstract
Background: endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain.
Methods: we plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons' preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants' preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at 12 months. Assuming a standard deviation of 22 points around the pain score, 90% power, 5% significance and 20% missing data, 400 participants are required to be randomised to detect an 8-point pain score difference.
Discussion: this trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE.
Trial registration: ISRCTN registry ISRCTN27244948. Registered 6 April 2021.
Text
s13063-023-07386-x
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More information
Accepted/In Press date: 18 May 2023
e-pub ahead of print date: 22 June 2023
Published date: 22 June 2023
Additional Information:
Funding Information:
We wish to acknowledge patient and public involvement group who contributed to trial design, development and delivery and the TSC and DMEC for their contribution to trial oversight. Medical Research Council (MRC) Centre grant to the Centre for Reproductive Health (CRH) (MR/N022556/1) is also gratefully acknowledged.
Funding Information:
CMB is the Chair of the ESHRE Endometriosis Guideline Group and a member of the NICE Endometriosis Guideline Group and a medical advisor to Endometriosis UK. DB was a member of the NICE endometriosis guideline group. YC was a member of ESHRE endometriosis guideline group. EC is an employee of Endometriosis UK. JH was a member of the NICE endometriosis guideline group. LH is the EPHect programme manager for the World Endometriosis Research Foundation and acts as an advisor for the Horizon 2020 funded FEMaLe project. KK is the former chair of the Endometriosis Association of Ireland. DCM is a retired gynaecologic surgeon; the volunteer Scientific and Medical Director of EndoFound (Endometriosis Foundation of America), a 501(c) (3) non-profit that funds research of endometriosis; an otherwise non-affiliated community member of the Institutional Review Board of the Virginia Commonwealth University; Professor Emeritus, the University of Tennessee Health Science Center; an unpaid medical advisor to SLBST Pharmaceuticals and Genomic Profiling LLC; and on the editorial board of five medical journals. KV is a Medical Advisor to Endometriosis UK. AWH is Trustee and Medical Advisor to Endometriosis UK. AWH was a member of the NICE and ESHRE Endometriosis Guideline Groups. LHRW is a member of the Early Career Board, World Endometriosis Society.
Funding Information:
We wish to acknowledge patient and public involvement group who contributed to trial design, development and delivery and the TSC and DMEC for their contribution to trial oversight. Medical Research Council (MRC) Centre grant to the Centre for Reproductive Health (CRH) (MR/N022556/1) is also gratefully acknowledged.
Funding Information:
This study is funded by the NIHR Health Technology Assessment programme (NIHR129801). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Publisher Copyright:
© 2023, The Author(s).
Keywords:
Endometriosis, Laparoscopy, Pelvic pain, Randomised controlled trial, Surgical ablation, Surgical excision
Identifiers
Local EPrints ID: 478661
URI: http://eprints.soton.ac.uk/id/eprint/478661
ISSN: 1745-6215
PURE UUID: dd30b769-b23c-4fb8-8efd-876c48cc1d7e
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Date deposited: 06 Jul 2023 16:50
Last modified: 15 Aug 2024 01:41
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Contributors
Author:
Scott C. Mackenzie
Author:
Jacqueline Stephen
Author:
Linda Williams
Author:
Jane Daniels
Author:
John Norrie
Author:
Christian M. Becker
Author:
Dominic Byrne
Author:
T. Justin Clark
Author:
Kevin G Cooper
Author:
Emma Cox
Author:
Ann M. Doust
Author:
Priscilla Fernandez
Author:
Jeremy Hawe
Author:
Tom Holland
Author:
Lone Hummelshoj
Author:
Louise J. Jackson
Author:
Kathleen King
Author:
Abha Maheshwari
Author:
Dan C. Martin
Author:
Lauren Sutherland
Author:
Jim Thornton
Author:
Katy Vincent
Author:
Sanjay Vyas
Author:
Andrew W. Horne
Author:
Lucy H.R. Whitaker
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