Cargando…
Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial
INTRODUCTION: Placebo-controlled surgical designs are recommended to ascertain treatment effects for elective surgeries when there is genuine doubt about the effectiveness of the surgery. Some elective surgeries for pain have been unable to show an effect beyond sham surgery, suggesting contribution...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9639085/ https://www.ncbi.nlm.nih.gov/pubmed/36328387 http://dx.doi.org/10.1136/bmjopen-2022-062808 |
_version_ | 1784825561153011712 |
---|---|
author | Marschall, Henrik Forman, Axel Lunde, Sigrid Juhl Kesmodel, Ulrik Schiøler Hansen, Karina Ejgaard Vase, Lene |
author_facet | Marschall, Henrik Forman, Axel Lunde, Sigrid Juhl Kesmodel, Ulrik Schiøler Hansen, Karina Ejgaard Vase, Lene |
author_sort | Marschall, Henrik |
collection | PubMed |
description | INTRODUCTION: Placebo-controlled surgical designs are recommended to ascertain treatment effects for elective surgeries when there is genuine doubt about the effectiveness of the surgery. Some elective surgeries for pain have been unable to show an effect beyond sham surgery, suggesting contributions from contextual factors. However, the nature of contextual factors in elective surgery is largely unexplored. Further, methodological difficulties in placebo-controlled surgical trials impact the ability to estimate the effectiveness of a surgical procedure. These include an overall lack of testing the success of blinding, absence of comparison to a no-surgery control group and dearth of test for neuropathic pain. For women with peritoneal endometriosis, there is uncertainty regarding the pain-relieving effect of surgery. Surgery may put patients at risk of complications such as postsurgical neuropathic pain, without guarantees of sufficient pelvic pain relief. The planned placebo-controlled trial aims to examine the effect of surgery on pelvic pain, widespread pain and neuropathic pain symptoms in women with peritoneal endometriosis, and to test the contribution of contextual factors to pain relief. METHODS AND ANALYSIS: One hundred women with peritoneal endometriosis will be randomised to either diagnostic laparoscopy with excision of endometrial tissue (active surgery), purely diagnostic laparoscopy (sham surgery) or delayed surgery (no-surgery control group). Outcomes include pelvic pain relief, widespread pain, neuropathic pain symptoms and quality of life. Contextual factors are also assessed. Assessments will be obtained at baseline and 1, 3 and 6 months postrandomisation. Mixed linear models will be used to compare groups over time on all outcome variables. ETHICS AND DISSEMINATION: The trial is approved by the Regional Ethics Committee in the Central Denmark Region (1-10-72-152-20). The trial is funded by a PhD scholarship from Aarhus University, and supported by a grant from ‘Helsefonden’ (20-B-0448). Findings will be published in international peer-reviewed journals and disseminated at international conferences. TRIAL REGISTRATION NUMBER: NCT05162794. |
format | Online Article Text |
id | pubmed-9639085 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-96390852022-11-08 Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial Marschall, Henrik Forman, Axel Lunde, Sigrid Juhl Kesmodel, Ulrik Schiøler Hansen, Karina Ejgaard Vase, Lene BMJ Open Surgery INTRODUCTION: Placebo-controlled surgical designs are recommended to ascertain treatment effects for elective surgeries when there is genuine doubt about the effectiveness of the surgery. Some elective surgeries for pain have been unable to show an effect beyond sham surgery, suggesting contributions from contextual factors. However, the nature of contextual factors in elective surgery is largely unexplored. Further, methodological difficulties in placebo-controlled surgical trials impact the ability to estimate the effectiveness of a surgical procedure. These include an overall lack of testing the success of blinding, absence of comparison to a no-surgery control group and dearth of test for neuropathic pain. For women with peritoneal endometriosis, there is uncertainty regarding the pain-relieving effect of surgery. Surgery may put patients at risk of complications such as postsurgical neuropathic pain, without guarantees of sufficient pelvic pain relief. The planned placebo-controlled trial aims to examine the effect of surgery on pelvic pain, widespread pain and neuropathic pain symptoms in women with peritoneal endometriosis, and to test the contribution of contextual factors to pain relief. METHODS AND ANALYSIS: One hundred women with peritoneal endometriosis will be randomised to either diagnostic laparoscopy with excision of endometrial tissue (active surgery), purely diagnostic laparoscopy (sham surgery) or delayed surgery (no-surgery control group). Outcomes include pelvic pain relief, widespread pain, neuropathic pain symptoms and quality of life. Contextual factors are also assessed. Assessments will be obtained at baseline and 1, 3 and 6 months postrandomisation. Mixed linear models will be used to compare groups over time on all outcome variables. ETHICS AND DISSEMINATION: The trial is approved by the Regional Ethics Committee in the Central Denmark Region (1-10-72-152-20). The trial is funded by a PhD scholarship from Aarhus University, and supported by a grant from ‘Helsefonden’ (20-B-0448). Findings will be published in international peer-reviewed journals and disseminated at international conferences. TRIAL REGISTRATION NUMBER: NCT05162794. BMJ Publishing Group 2022-11-03 /pmc/articles/PMC9639085/ /pubmed/36328387 http://dx.doi.org/10.1136/bmjopen-2022-062808 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Surgery Marschall, Henrik Forman, Axel Lunde, Sigrid Juhl Kesmodel, Ulrik Schiøler Hansen, Karina Ejgaard Vase, Lene Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial |
title | Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial |
title_full | Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial |
title_fullStr | Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial |
title_full_unstemmed | Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial |
title_short | Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial |
title_sort | is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial |
topic | Surgery |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9639085/ https://www.ncbi.nlm.nih.gov/pubmed/36328387 http://dx.doi.org/10.1136/bmjopen-2022-062808 |
work_keys_str_mv | AT marschallhenrik islaparoscopicexcisionforsuperficialperitonealendometriosishelpfulorharmfulprotocolforadoubleblindedrandomisedplacebocontrolledthreearmedsurgicaltrial AT formanaxel islaparoscopicexcisionforsuperficialperitonealendometriosishelpfulorharmfulprotocolforadoubleblindedrandomisedplacebocontrolledthreearmedsurgicaltrial AT lundesigridjuhl islaparoscopicexcisionforsuperficialperitonealendometriosishelpfulorharmfulprotocolforadoubleblindedrandomisedplacebocontrolledthreearmedsurgicaltrial AT kesmodelulrikschiøler islaparoscopicexcisionforsuperficialperitonealendometriosishelpfulorharmfulprotocolforadoubleblindedrandomisedplacebocontrolledthreearmedsurgicaltrial AT hansenkarinaejgaard islaparoscopicexcisionforsuperficialperitonealendometriosishelpfulorharmfulprotocolforadoubleblindedrandomisedplacebocontrolledthreearmedsurgicaltrial AT vaselene islaparoscopicexcisionforsuperficialperitonealendometriosishelpfulorharmfulprotocolforadoubleblindedrandomisedplacebocontrolledthreearmedsurgicaltrial |