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

Scott C. Mackenzie; Jacqueline Stephen; Linda Williams; Jane Daniels; John Norrie; Christian M. Becker; Dominic Byrne; Ying Cheong; T. Justin Clark; Kevin G. Cooper; Emma Cox; Ann M. Doust; Priscilla Fernandez; Jeremy Hawe; Tom Holland; Lone Hummelshoj; Louise J. Jackson; Kathleen King; Abha Maheshwari; Dan C. Martin; Lauren Sutherland; Jim Thornton; Katy Vincent; Sanjay Vyas; Andrew W. Horne; Lucy H.R. Whitaker

doi:10.1186/s13063-023-07386-x

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

Scott C. Mackenzie, Jacqueline Stephen, Linda Williams, Jane Daniels, John Norrie, Christian M. Becker, Dominic Byrne, Ying Cheong, T. Justin Clark, Kevin G. Cooper, Emma Cox, Ann M. Doust, Priscilla Fernandez, Jeremy Hawe, Tom Holland, Lone Hummelshoj, Louise J. Jackson, Kathleen King, Abha Maheshwari, Dan C. MartinLauren Sutherland, Jim Thornton, Katy Vincent, Sanjay Vyas, Andrew W. Horne, Lucy H.R. Whitaker^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

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.

Original language	English
Article number	425
Number of pages	15
Journal	Trials
Volume	24
Issue number	1
DOIs	https://doi.org/10.1186/s13063-023-07386-x
Publication status	Published - 22 Jun 2023
Externally published	Yes

Bibliographical note

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

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Mackenzie, S. C., Stephen, J., Williams, L., Daniels, J., Norrie, J., Becker, C. M., Byrne, D., Cheong, Y., Clark, T. J., Cooper, K. G., Cox, E., Doust, A. M., Fernandez, P., Hawe, J., Holland, T., Hummelshoj, L., Jackson, L. J., King, K., Maheshwari, A., ... Whitaker, L. 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), Article 425. https://doi.org/10.1186/s13063-023-07386-x

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. / Mackenzie, Scott C.; Stephen, Jacqueline; Williams, Linda et al.
In: Trials, Vol. 24, No. 1, 425, 22.06.2023.

Research output: Contribution to journal › Article › peer-review

Mackenzie, SC, Stephen, J, Williams, L, Daniels, J, Norrie, J, Becker, CM, Byrne, D, Cheong, Y, Clark, TJ, Cooper, KG, Cox, E, Doust, AM, Fernandez, P, Hawe, J, Holland, T, Hummelshoj, L, Jackson, LJ, King, K, Maheshwari, A, Martin, DC, Sutherland, L, Thornton, J, Vincent, K, Vyas, S, Horne, AW & Whitaker, LHR 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, vol. 24, no. 1, 425. https://doi.org/10.1186/s13063-023-07386-x

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title = "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",

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{\textquoteright} 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{\textquoteright} 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.",

keywords = "Endometriosis, Laparoscopy, Pelvic pain, Randomised controlled trial, Surgical ablation, Surgical excision",

author = "Mackenzie, {Scott C.} and Jacqueline Stephen and Linda Williams and Jane Daniels and John Norrie and Becker, {Christian M.} and Dominic Byrne and Ying Cheong and Clark, {T. Justin} and Cooper, {Kevin G.} and Emma Cox and Doust, {Ann M.} and Priscilla Fernandez and Jeremy Hawe and Tom Holland and Lone Hummelshoj and Jackson, {Louise J.} and Kathleen King and Abha Maheshwari and Martin, {Dan C.} and Lauren Sutherland and Jim Thornton and Katy Vincent and Sanjay Vyas and Horne, {Andrew W.} and Whitaker, {Lucy H.R.}",

note = "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: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = jun,

day = "22",

doi = "10.1186/s13063-023-07386-x",

language = "English",

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TY - JOUR

T1 - Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2)

T2 - protocol for a multi-centre randomised controlled trial

AU - Mackenzie, Scott C.

AU - Stephen, Jacqueline

AU - Williams, Linda

AU - Daniels, Jane

AU - Norrie, John

AU - Becker, Christian M.

AU - Byrne, Dominic

AU - Cheong, Ying

AU - Clark, T. Justin

AU - Cooper, Kevin G.

AU - Cox, Emma

AU - Doust, Ann M.

AU - Fernandez, Priscilla

AU - Hawe, Jeremy

AU - Holland, Tom

AU - Hummelshoj, Lone

AU - Jackson, Louise J.

AU - King, Kathleen

AU - Maheshwari, Abha

AU - Martin, Dan C.

AU - Sutherland, Lauren

AU - Thornton, Jim

AU - Vincent, Katy

AU - Vyas, Sanjay

AU - Horne, Andrew W.

AU - Whitaker, Lucy H.R.

N1 - 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).

PY - 2023/6/22

Y1 - 2023/6/22

N2 - 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.

AB - 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.

KW - Endometriosis

KW - Laparoscopy

KW - Pelvic pain

KW - Randomised controlled trial

KW - Surgical ablation

KW - Surgical excision

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ER -

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

Abstract

Bibliographical note

Keywords

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