Laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy for vaginal vault prolapse: long-term follow-up of a randomized controlled trial
Introduction and hypothesis The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP). Methods Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 7...
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| Veröffentlicht in: | International Urogynecology Journal 2023-01, Vol.34 (1), p.93-104 |
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| creator | van Oudheusden, Anique M. J. Eissing, Josephine Terink, Ivon M. Vink, Maarten D. H. van Kuijk, Sander M. J. Bongers, Marlies Y. Coolen, Anne-Lotte W. M. |
| description | Introduction and hypothesis
The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP).
Methods
Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC (
n
=37) or ASC (
n
=37). Primary outcome was disease-specific quality of life, measured with validated questionnaires. Secondary outcomes included anatomical outcome, composite outcome of success, complications, and retreatment.
Results
We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0–17; ASC: IQR 0–0) on the “genital prolapse” domain of the Urogenital Distress Inventory in both groups (
p
= 0.175). Anatomical outcomes were the same for both groups on all points of the POP-Q. The composite outcome of success for the apical compartment is 78.6% (
n
= 11) in the LSC group and 84.6% (
n
= 11) in the ASC group (
p
= 0.686). Mesh exposures occurred in 2 patients (12.5%) in the LSC group and 1 patient (7.7%) in the ASC group. There were 5 surgical reinterventions in both groups (LSC: 22.7%; ASC: 26.3%,
p
= 0.729).
Conclusions
At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages.
Trial registration
Dutch Trial Register NTR6330, 18 January 2017,
https://www.trialregister.nl/trial/5964 |
| doi_str_mv | 10.1007/s00192-022-05350-y |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9483545</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2715442747</sourcerecordid><originalsourceid>FETCH-LOGICAL-c474t-2adac7f1a599db35fb519fa2477a6de93c68f980d1cafa0102c7651f1254d77f3</originalsourceid><addsrcrecordid>eNp9kc2KFDEUhYMoTjv6Ai4k4MZN6c1fpeNCkME_aHCj63A7lbQ1pCplUtXaPoMPbXp6HHUWLkIC57vn3txDyGMGzxmAflEAmOEN8HqUUNAc7pAVk0I0Ari4S1ZghG6EbPkZeVDKJQBIUHCfnImWMc7WfEV-bnDCnIpLU-9oQZeTS3FKk_9-oHufy1Iobrs09CPG23pIme5xdyXtcYkznXKKOBX_ksY07prZ56FSMaZvzTLRFCjSjOPR7ofvqEvjXAtifc65x_iQ3AsYi390fZ-Tz2_ffLp432w-vvtw8XrTOKnl3HDs0OnAUBnTbYUKW8VMQC61xrbzRrh2HcwaOuYwIDDgTreKBcaV7LQO4py8OvlOy3bwnfN1DIx2yv2A-WAT9vZfZey_2F3aWyPXQklVDZ5dG-T0dfFltkNfnI8RR5-WYrlmSkqupa7o01voZVpy3diRaoVRZs2hUvxE1f2Wkn24GYaBPYZtT2HbGra9CtseatGTv79xU_I73QqIE1CqNO58_tP7P7a_ALpcup4</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2763959820</pqid></control><display><type>article</type><title>Laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy for vaginal vault prolapse: long-term follow-up of a randomized controlled trial</title><source>MEDLINE</source><source>SpringerNature Journals</source><creator>van Oudheusden, Anique M. J. ; Eissing, Josephine ; Terink, Ivon M. ; Vink, Maarten D. H. ; van Kuijk, Sander M. J. ; Bongers, Marlies Y. ; Coolen, Anne-Lotte W. M.</creator><creatorcontrib>van Oudheusden, Anique M. J. ; Eissing, Josephine ; Terink, Ivon M. ; Vink, Maarten D. H. ; van Kuijk, Sander M. J. ; Bongers, Marlies Y. ; Coolen, Anne-Lotte W. M.</creatorcontrib><description>Introduction and hypothesis
The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP).
Methods
Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC (
n
=37) or ASC (
n
=37). Primary outcome was disease-specific quality of life, measured with validated questionnaires. Secondary outcomes included anatomical outcome, composite outcome of success, complications, and retreatment.
Results
We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0–17; ASC: IQR 0–0) on the “genital prolapse” domain of the Urogenital Distress Inventory in both groups (
p
= 0.175). Anatomical outcomes were the same for both groups on all points of the POP-Q. The composite outcome of success for the apical compartment is 78.6% (
n
= 11) in the LSC group and 84.6% (
n
= 11) in the ASC group (
p
= 0.686). Mesh exposures occurred in 2 patients (12.5%) in the LSC group and 1 patient (7.7%) in the ASC group. There were 5 surgical reinterventions in both groups (LSC: 22.7%; ASC: 26.3%,
p
= 0.729).
Conclusions
At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages.
Trial registration
Dutch Trial Register NTR6330, 18 January 2017,
https://www.trialregister.nl/trial/5964</description><identifier>ISSN: 0937-3462</identifier><identifier>EISSN: 1433-3023</identifier><identifier>DOI: 10.1007/s00192-022-05350-y</identifier><identifier>PMID: 36112182</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Clinical trials ; Female ; Follow-Up Studies ; Gynecologic Surgical Procedures - methods ; Gynecology ; Humans ; Laparoscopy ; Laparoscopy - adverse effects ; Laparoscopy - methods ; Medicine ; Medicine & Public Health ; Original ; Original Article ; Pelvic Organ Prolapse - etiology ; Pelvic Organ Prolapse - surgery ; Quality of Life ; Surgical Mesh - adverse effects ; Treatment Outcome ; Urology ; Vagina</subject><ispartof>International Urogynecology Journal, 2023-01, Vol.34 (1), p.93-104</ispartof><rights>The Author(s) 2022</rights><rights>2022. The Author(s).</rights><rights>The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-2adac7f1a599db35fb519fa2477a6de93c68f980d1cafa0102c7651f1254d77f3</citedby><cites>FETCH-LOGICAL-c474t-2adac7f1a599db35fb519fa2477a6de93c68f980d1cafa0102c7651f1254d77f3</cites><orcidid>0000-0001-7984-9223</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00192-022-05350-y$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00192-022-05350-y$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36112182$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van Oudheusden, Anique M. J.</creatorcontrib><creatorcontrib>Eissing, Josephine</creatorcontrib><creatorcontrib>Terink, Ivon M.</creatorcontrib><creatorcontrib>Vink, Maarten D. H.</creatorcontrib><creatorcontrib>van Kuijk, Sander M. J.</creatorcontrib><creatorcontrib>Bongers, Marlies Y.</creatorcontrib><creatorcontrib>Coolen, Anne-Lotte W. M.</creatorcontrib><title>Laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy for vaginal vault prolapse: long-term follow-up of a randomized controlled trial</title><title>International Urogynecology Journal</title><addtitle>Int Urogynecol J</addtitle><addtitle>Int Urogynecol J</addtitle><description>Introduction and hypothesis
The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP).
Methods
Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC (
n
=37) or ASC (
n
=37). Primary outcome was disease-specific quality of life, measured with validated questionnaires. Secondary outcomes included anatomical outcome, composite outcome of success, complications, and retreatment.
Results
We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0–17; ASC: IQR 0–0) on the “genital prolapse” domain of the Urogenital Distress Inventory in both groups (
p
= 0.175). Anatomical outcomes were the same for both groups on all points of the POP-Q. The composite outcome of success for the apical compartment is 78.6% (
n
= 11) in the LSC group and 84.6% (
n
= 11) in the ASC group (
p
= 0.686). Mesh exposures occurred in 2 patients (12.5%) in the LSC group and 1 patient (7.7%) in the ASC group. There were 5 surgical reinterventions in both groups (LSC: 22.7%; ASC: 26.3%,
p
= 0.729).
Conclusions
At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages.
Trial registration
Dutch Trial Register NTR6330, 18 January 2017,
https://www.trialregister.nl/trial/5964</description><subject>Clinical trials</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gynecologic Surgical Procedures - methods</subject><subject>Gynecology</subject><subject>Humans</subject><subject>Laparoscopy</subject><subject>Laparoscopy - adverse effects</subject><subject>Laparoscopy - methods</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original</subject><subject>Original Article</subject><subject>Pelvic Organ Prolapse - etiology</subject><subject>Pelvic Organ Prolapse - surgery</subject><subject>Quality of Life</subject><subject>Surgical Mesh - adverse effects</subject><subject>Treatment Outcome</subject><subject>Urology</subject><subject>Vagina</subject><issn>0937-3462</issn><issn>1433-3023</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kc2KFDEUhYMoTjv6Ai4k4MZN6c1fpeNCkME_aHCj63A7lbQ1pCplUtXaPoMPbXp6HHUWLkIC57vn3txDyGMGzxmAflEAmOEN8HqUUNAc7pAVk0I0Ari4S1ZghG6EbPkZeVDKJQBIUHCfnImWMc7WfEV-bnDCnIpLU-9oQZeTS3FKk_9-oHufy1Iobrs09CPG23pIme5xdyXtcYkznXKKOBX_ksY07prZ56FSMaZvzTLRFCjSjOPR7ofvqEvjXAtifc65x_iQ3AsYi390fZ-Tz2_ffLp432w-vvtw8XrTOKnl3HDs0OnAUBnTbYUKW8VMQC61xrbzRrh2HcwaOuYwIDDgTreKBcaV7LQO4py8OvlOy3bwnfN1DIx2yv2A-WAT9vZfZey_2F3aWyPXQklVDZ5dG-T0dfFltkNfnI8RR5-WYrlmSkqupa7o01voZVpy3diRaoVRZs2hUvxE1f2Wkn24GYaBPYZtT2HbGra9CtseatGTv79xU_I73QqIE1CqNO58_tP7P7a_ALpcup4</recordid><startdate>20230101</startdate><enddate>20230101</enddate><creator>van Oudheusden, Anique M. J.</creator><creator>Eissing, Josephine</creator><creator>Terink, Ivon M.</creator><creator>Vink, Maarten D. H.</creator><creator>van Kuijk, Sander M. J.</creator><creator>Bongers, Marlies Y.</creator><creator>Coolen, Anne-Lotte W. M.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>C6C</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>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7984-9223</orcidid></search><sort><creationdate>20230101</creationdate><title>Laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy for vaginal vault prolapse: long-term follow-up of a randomized controlled trial</title><author>van Oudheusden, Anique M. J. ; Eissing, Josephine ; Terink, Ivon M. ; Vink, Maarten D. H. ; van Kuijk, Sander M. J. ; Bongers, Marlies Y. ; Coolen, Anne-Lotte W. M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-2adac7f1a599db35fb519fa2477a6de93c68f980d1cafa0102c7651f1254d77f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Clinical trials</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gynecologic Surgical Procedures - methods</topic><topic>Gynecology</topic><topic>Humans</topic><topic>Laparoscopy</topic><topic>Laparoscopy - adverse effects</topic><topic>Laparoscopy - methods</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original</topic><topic>Original Article</topic><topic>Pelvic Organ Prolapse - etiology</topic><topic>Pelvic Organ Prolapse - surgery</topic><topic>Quality of Life</topic><topic>Surgical Mesh - adverse effects</topic><topic>Treatment Outcome</topic><topic>Urology</topic><topic>Vagina</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>van Oudheusden, Anique M. J.</creatorcontrib><creatorcontrib>Eissing, Josephine</creatorcontrib><creatorcontrib>Terink, Ivon M.</creatorcontrib><creatorcontrib>Vink, Maarten D. H.</creatorcontrib><creatorcontrib>van Kuijk, Sander M. J.</creatorcontrib><creatorcontrib>Bongers, Marlies Y.</creatorcontrib><creatorcontrib>Coolen, Anne-Lotte W. M.</creatorcontrib><collection>Springer Nature OA Free Journals</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>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</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</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>International Urogynecology Journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>van Oudheusden, Anique M. J.</au><au>Eissing, Josephine</au><au>Terink, Ivon M.</au><au>Vink, Maarten D. H.</au><au>van Kuijk, Sander M. J.</au><au>Bongers, Marlies Y.</au><au>Coolen, Anne-Lotte W. M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy for vaginal vault prolapse: long-term follow-up of a randomized controlled trial</atitle><jtitle>International Urogynecology Journal</jtitle><stitle>Int Urogynecol J</stitle><addtitle>Int Urogynecol J</addtitle><date>2023-01-01</date><risdate>2023</risdate><volume>34</volume><issue>1</issue><spage>93</spage><epage>104</epage><pages>93-104</pages><issn>0937-3462</issn><eissn>1433-3023</eissn><abstract>Introduction and hypothesis
The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP).
Methods
Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC (
n
=37) or ASC (
n
=37). Primary outcome was disease-specific quality of life, measured with validated questionnaires. Secondary outcomes included anatomical outcome, composite outcome of success, complications, and retreatment.
Results
We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0–17; ASC: IQR 0–0) on the “genital prolapse” domain of the Urogenital Distress Inventory in both groups (
p
= 0.175). Anatomical outcomes were the same for both groups on all points of the POP-Q. The composite outcome of success for the apical compartment is 78.6% (
n
= 11) in the LSC group and 84.6% (
n
= 11) in the ASC group (
p
= 0.686). Mesh exposures occurred in 2 patients (12.5%) in the LSC group and 1 patient (7.7%) in the ASC group. There were 5 surgical reinterventions in both groups (LSC: 22.7%; ASC: 26.3%,
p
= 0.729).
Conclusions
At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages.
Trial registration
Dutch Trial Register NTR6330, 18 January 2017,
https://www.trialregister.nl/trial/5964</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>36112182</pmid><doi>10.1007/s00192-022-05350-y</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0001-7984-9223</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| source | MEDLINE; SpringerNature Journals |
| subjects | Clinical trials Female Follow-Up Studies Gynecologic Surgical Procedures - methods Gynecology Humans Laparoscopy Laparoscopy - adverse effects Laparoscopy - methods Medicine Medicine & Public Health Original Original Article Pelvic Organ Prolapse - etiology Pelvic Organ Prolapse - surgery Quality of Life Surgical Mesh - adverse effects Treatment Outcome Urology Vagina |
| title | Laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy for vaginal vault prolapse: long-term follow-up of a randomized controlled trial |
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