HALON—hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol)
IntroductionNatural orifice transluminal endoscopic surgery (NOTES) uses natural body orifices to access the cavities of the human body to perform surgery. NOTES limits the magnitude of surgical trauma and has the potential to reduce postoperative pain. This is the first randomised study in women bo...
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| Veröffentlicht in: | BMJ open 2016-08, Vol.6 (8), p.e011546-e011546 |
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| creator | Baekelandt, Jan De Mulder, Peter A Le Roy, Ilse Mathieu, Chantal Laenen, Annouschka Enzlin, Paul Weyers, Steven Mol, Ben WJ Bosteels, Jan JA |
| description | IntroductionNatural orifice transluminal endoscopic surgery (NOTES) uses natural body orifices to access the cavities of the human body to perform surgery. NOTES limits the magnitude of surgical trauma and has the potential to reduce postoperative pain. This is the first randomised study in women bound to undergo hysterectomy for benign gynaecological disease comparing NOTES with classical laparoscopy.Methods and analysisAll women aged 18–70 years, regardless of parity, consulting at our practice with an indication for hysterectomy due to benign gynaecological disease will be eligible. After stratification according to uterine size on clinical examination, participants will be randomised to be treated by laparoscopy or by transvaginal NOTES. Participants will be evaluated on day 0, days 1–7 and at 3 and 6 months. The following data will be collected: the proportion of women successfully treated by removing the uterus by the intended approach as randomised; the proportion of women admitted to the inpatient hospital; postoperative pain scores measured twice daily by the women from day 1 to 7; the total amount of analgesics used from day 1 to 7; readmission during the first 6 weeks; presence and intensity of dyspareunia and sexual well-being at baseline, 3 and 6 months (Short Sexual Functioning Scale (SSFS) scale); duration of surgery; postoperative infection or other surgical complications; direct and indirect costs incurred up to 6 weeks following surgery. The primary outcome will be the proportion of women successfully treated by the intended technique; all other outcomes are secondary.Ethics and disseminationThe study was approved on 1 December 2015 by the Ethics Committee of the Imelda Hospital, Bonheiden, Belgium. The first patient was randomised on 17 December 2015. The last participant randomised should be treated before 30 November 2017. The results will be presented in peer-reviewed journals and at scientific meetings within 4 years after starting recruitment.Trial registration numberNCT02631837; Pre-results. |
| doi_str_mv | 10.1136/bmjopen-2016-011546 |
| format | Article |
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NOTES limits the magnitude of surgical trauma and has the potential to reduce postoperative pain. This is the first randomised study in women bound to undergo hysterectomy for benign gynaecological disease comparing NOTES with classical laparoscopy.Methods and analysisAll women aged 18–70 years, regardless of parity, consulting at our practice with an indication for hysterectomy due to benign gynaecological disease will be eligible. After stratification according to uterine size on clinical examination, participants will be randomised to be treated by laparoscopy or by transvaginal NOTES. Participants will be evaluated on day 0, days 1–7 and at 3 and 6 months. The following data will be collected: the proportion of women successfully treated by removing the uterus by the intended approach as randomised; the proportion of women admitted to the inpatient hospital; postoperative pain scores measured twice daily by the women from day 1 to 7; the total amount of analgesics used from day 1 to 7; readmission during the first 6 weeks; presence and intensity of dyspareunia and sexual well-being at baseline, 3 and 6 months (Short Sexual Functioning Scale (SSFS) scale); duration of surgery; postoperative infection or other surgical complications; direct and indirect costs incurred up to 6 weeks following surgery. The primary outcome will be the proportion of women successfully treated by the intended technique; all other outcomes are secondary.Ethics and disseminationThe study was approved on 1 December 2015 by the Ethics Committee of the Imelda Hospital, Bonheiden, Belgium. The first patient was randomised on 17 December 2015. The last participant randomised should be treated before 30 November 2017. The results will be presented in peer-reviewed journals and at scientific meetings within 4 years after starting recruitment.Trial registration numberNCT02631837; Pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2016-011546</identifier><identifier>PMID: 27519922</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Abdomen ; Adolescent ; Adult ; Aged ; Analgesics - therapeutic use ; Belgium ; Bladder ; Cervix ; Dyspareunia - epidemiology ; Endoscopy ; Female ; Health Care Costs ; Hospitalization - statistics & numerical data ; Hospitals ; Humans ; Hysterectomy ; Hysterectomy - economics ; Hysterectomy - methods ; Laparoscopy ; Laparoscopy - economics ; Laparoscopy - methods ; Middle Aged ; Natural Orifice Endoscopic Surgery - economics ; Natural Orifice Endoscopic Surgery - methods ; Obstetrics and Gynaecology ; Pain, Postoperative - drug therapy ; Postoperative Complications - epidemiology ; Pregnancy ; Surgery ; Uterine Diseases - surgery ; Uterus ; Vagina ; Womens health ; Young Adult</subject><ispartof>BMJ open, 2016-08, Vol.6 (8), p.e011546-e011546</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2016 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 and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b500t-e1e741746096e782c654a1c38048aa1514f493427f2bedf7a1d9715d2a7766f23</citedby><cites>FETCH-LOGICAL-b500t-e1e741746096e782c654a1c38048aa1514f493427f2bedf7a1d9715d2a7766f23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmjopen.bmj.com/content/6/8/e011546.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmjopen.bmj.com/content/6/8/e011546.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27549,27550,27924,27925,53791,53793,77601,77632</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27519922$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Baekelandt, Jan</creatorcontrib><creatorcontrib>De Mulder, Peter A</creatorcontrib><creatorcontrib>Le Roy, Ilse</creatorcontrib><creatorcontrib>Mathieu, Chantal</creatorcontrib><creatorcontrib>Laenen, Annouschka</creatorcontrib><creatorcontrib>Enzlin, Paul</creatorcontrib><creatorcontrib>Weyers, Steven</creatorcontrib><creatorcontrib>Mol, Ben WJ</creatorcontrib><creatorcontrib>Bosteels, Jan JA</creatorcontrib><title>HALON—hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol)</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionNatural orifice transluminal endoscopic surgery (NOTES) uses natural body orifices to access the cavities of the human body to perform surgery. NOTES limits the magnitude of surgical trauma and has the potential to reduce postoperative pain. This is the first randomised study in women bound to undergo hysterectomy for benign gynaecological disease comparing NOTES with classical laparoscopy.Methods and analysisAll women aged 18–70 years, regardless of parity, consulting at our practice with an indication for hysterectomy due to benign gynaecological disease will be eligible. After stratification according to uterine size on clinical examination, participants will be randomised to be treated by laparoscopy or by transvaginal NOTES. Participants will be evaluated on day 0, days 1–7 and at 3 and 6 months. The following data will be collected: the proportion of women successfully treated by removing the uterus by the intended approach as randomised; the proportion of women admitted to the inpatient hospital; postoperative pain scores measured twice daily by the women from day 1 to 7; the total amount of analgesics used from day 1 to 7; readmission during the first 6 weeks; presence and intensity of dyspareunia and sexual well-being at baseline, 3 and 6 months (Short Sexual Functioning Scale (SSFS) scale); duration of surgery; postoperative infection or other surgical complications; direct and indirect costs incurred up to 6 weeks following surgery. The primary outcome will be the proportion of women successfully treated by the intended technique; all other outcomes are secondary.Ethics and disseminationThe study was approved on 1 December 2015 by the Ethics Committee of the Imelda Hospital, Bonheiden, Belgium. The first patient was randomised on 17 December 2015. The last participant randomised should be treated before 30 November 2017. The results will be presented in peer-reviewed journals and at scientific meetings within 4 years after starting recruitment.Trial registration numberNCT02631837; Pre-results.</description><subject>Abdomen</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Analgesics - therapeutic use</subject><subject>Belgium</subject><subject>Bladder</subject><subject>Cervix</subject><subject>Dyspareunia - epidemiology</subject><subject>Endoscopy</subject><subject>Female</subject><subject>Health Care Costs</subject><subject>Hospitalization - statistics & numerical data</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hysterectomy</subject><subject>Hysterectomy - economics</subject><subject>Hysterectomy - methods</subject><subject>Laparoscopy</subject><subject>Laparoscopy - economics</subject><subject>Laparoscopy - methods</subject><subject>Middle Aged</subject><subject>Natural Orifice Endoscopic Surgery - economics</subject><subject>Natural Orifice Endoscopic Surgery - methods</subject><subject>Obstetrics and Gynaecology</subject><subject>Pain, Postoperative - drug therapy</subject><subject>Postoperative Complications - epidemiology</subject><subject>Pregnancy</subject><subject>Surgery</subject><subject>Uterine Diseases - surgery</subject><subject>Uterus</subject><subject>Vagina</subject><subject>Womens health</subject><subject>Young Adult</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkc1u1TAQhS1ERau2T4CELLEpixSP45-EBVJVAUW6ajewthzHaXPlxMF2kLLjIeAFeRJ8m0tVWNUbj-zvHM3MQeglkHOAUrxthq2f7FhQAqIgAJyJZ-iIEsYKQTh__qg-RKcxbkk-jNec0xfokEoOdU3pEfp1dbG5uf794-fdEpMN1iQ_LLhZcAp6jLpp_dCP2mGnJx18NH5asA941GkO-dmHvuuNXWk3r6wd23uyNzjO4daG5R3WOBM7s2hbbPyYgnculyn0WXEW09wueAo-eePdmxN00GkX7en-PkZfP374cnlVbG4-fb682BQNJyQVFqxkIJkgtbCyokZwpsGUFWGV1sCBdawuGZUdbWzbSQ1tLYG3VEspREfLY_R-9Z3mZrCtsbkv7dQU-kGHRXndq39_xv5O3frvitUVr6s6G5ztDYL_NtuYVJ7QWOf0aP0cFVRAGStpuUNf_4du_Rzyvu4poELmmTJVrpTJ247Bdg_NAFG75NU-ebVLXq3JZ9Wrx3M8aP7mnIHzFcjqJzn-AdBCvs0</recordid><startdate>20160812</startdate><enddate>20160812</enddate><creator>Baekelandt, Jan</creator><creator>De Mulder, Peter A</creator><creator>Le Roy, Ilse</creator><creator>Mathieu, Chantal</creator><creator>Laenen, Annouschka</creator><creator>Enzlin, Paul</creator><creator>Weyers, Steven</creator><creator>Mol, Ben WJ</creator><creator>Bosteels, Jan JA</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20160812</creationdate><title>HALON—hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol)</title><author>Baekelandt, Jan ; De Mulder, Peter A ; Le Roy, Ilse ; Mathieu, Chantal ; Laenen, Annouschka ; Enzlin, Paul ; Weyers, Steven ; Mol, Ben WJ ; Bosteels, Jan JA</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b500t-e1e741746096e782c654a1c38048aa1514f493427f2bedf7a1d9715d2a7766f23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Abdomen</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Analgesics - therapeutic use</topic><topic>Belgium</topic><topic>Bladder</topic><topic>Cervix</topic><topic>Dyspareunia - epidemiology</topic><topic>Endoscopy</topic><topic>Female</topic><topic>Health Care Costs</topic><topic>Hospitalization - statistics & numerical data</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hysterectomy</topic><topic>Hysterectomy - economics</topic><topic>Hysterectomy - methods</topic><topic>Laparoscopy</topic><topic>Laparoscopy - economics</topic><topic>Laparoscopy - methods</topic><topic>Middle Aged</topic><topic>Natural Orifice Endoscopic Surgery - economics</topic><topic>Natural Orifice Endoscopic Surgery - methods</topic><topic>Obstetrics and Gynaecology</topic><topic>Pain, Postoperative - drug therapy</topic><topic>Postoperative Complications - epidemiology</topic><topic>Pregnancy</topic><topic>Surgery</topic><topic>Uterine Diseases - surgery</topic><topic>Uterus</topic><topic>Vagina</topic><topic>Womens health</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Baekelandt, Jan</creatorcontrib><creatorcontrib>De Mulder, Peter A</creatorcontrib><creatorcontrib>Le Roy, Ilse</creatorcontrib><creatorcontrib>Mathieu, Chantal</creatorcontrib><creatorcontrib>Laenen, Annouschka</creatorcontrib><creatorcontrib>Enzlin, Paul</creatorcontrib><creatorcontrib>Weyers, Steven</creatorcontrib><creatorcontrib>Mol, Ben WJ</creatorcontrib><creatorcontrib>Bosteels, Jan JA</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Baekelandt, Jan</au><au>De Mulder, Peter A</au><au>Le Roy, Ilse</au><au>Mathieu, Chantal</au><au>Laenen, Annouschka</au><au>Enzlin, Paul</au><au>Weyers, Steven</au><au>Mol, Ben WJ</au><au>Bosteels, Jan JA</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>HALON—hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol)</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2016-08-12</date><risdate>2016</risdate><volume>6</volume><issue>8</issue><spage>e011546</spage><epage>e011546</epage><pages>e011546-e011546</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionNatural orifice transluminal endoscopic surgery (NOTES) uses natural body orifices to access the cavities of the human body to perform surgery. NOTES limits the magnitude of surgical trauma and has the potential to reduce postoperative pain. This is the first randomised study in women bound to undergo hysterectomy for benign gynaecological disease comparing NOTES with classical laparoscopy.Methods and analysisAll women aged 18–70 years, regardless of parity, consulting at our practice with an indication for hysterectomy due to benign gynaecological disease will be eligible. After stratification according to uterine size on clinical examination, participants will be randomised to be treated by laparoscopy or by transvaginal NOTES. Participants will be evaluated on day 0, days 1–7 and at 3 and 6 months. The following data will be collected: the proportion of women successfully treated by removing the uterus by the intended approach as randomised; the proportion of women admitted to the inpatient hospital; postoperative pain scores measured twice daily by the women from day 1 to 7; the total amount of analgesics used from day 1 to 7; readmission during the first 6 weeks; presence and intensity of dyspareunia and sexual well-being at baseline, 3 and 6 months (Short Sexual Functioning Scale (SSFS) scale); duration of surgery; postoperative infection or other surgical complications; direct and indirect costs incurred up to 6 weeks following surgery. The primary outcome will be the proportion of women successfully treated by the intended technique; all other outcomes are secondary.Ethics and disseminationThe study was approved on 1 December 2015 by the Ethics Committee of the Imelda Hospital, Bonheiden, Belgium. The first patient was randomised on 17 December 2015. The last participant randomised should be treated before 30 November 2017. The results will be presented in peer-reviewed journals and at scientific meetings within 4 years after starting recruitment.Trial registration numberNCT02631837; Pre-results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>27519922</pmid><doi>10.1136/bmjopen-2016-011546</doi><oa>free_for_read</oa></addata></record> |
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| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; PubMed Central Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Abdomen Adolescent Adult Aged Analgesics - therapeutic use Belgium Bladder Cervix Dyspareunia - epidemiology Endoscopy Female Health Care Costs Hospitalization - statistics & numerical data Hospitals Humans Hysterectomy Hysterectomy - economics Hysterectomy - methods Laparoscopy Laparoscopy - economics Laparoscopy - methods Middle Aged Natural Orifice Endoscopic Surgery - economics Natural Orifice Endoscopic Surgery - methods Obstetrics and Gynaecology Pain, Postoperative - drug therapy Postoperative Complications - epidemiology Pregnancy Surgery Uterine Diseases - surgery Uterus Vagina Womens health Young Adult |
| title | HALON—hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol) |
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