Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol
Abstract Background Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be...
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| Format: | Article |
| Language: | English |
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BMC
2017-07-01
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| Series: | BMC Women's Health |
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| Online Access: | http://link.springer.com/article/10.1186/s12905-017-0402-2 |
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| author | Anne-Lotte W. M. Coolen Mèlanie N. van IJsselmuiden Anique M. J. van Oudheusden J. Veen Hugo W. F. van Eijndhoven Ben Willem J. Mol Jan Paul Roovers Marlies Y. Bongers |
| author_facet | Anne-Lotte W. M. Coolen Mèlanie N. van IJsselmuiden Anique M. J. van Oudheusden J. Veen Hugo W. F. van Eijndhoven Ben Willem J. Mol Jan Paul Roovers Marlies Y. Bongers |
| author_sort | Anne-Lotte W. M. Coolen |
| collection | DOAJ |
| description | Abstract Background Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic sacrocolpopexy as the treatment of vaginal vault prolapse. Methods We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included. Discussion The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse. Trial registration Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013. |
| first_indexed | 2024-12-16T17:30:58Z |
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| id | doaj.art-258b18be2eca4cb3bee9910a2e6feeb4 |
| institution | Directory Open Access Journal |
| issn | 1472-6874 |
| language | English |
| last_indexed | 2024-12-16T17:30:58Z |
| publishDate | 2017-07-01 |
| publisher | BMC |
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| series | BMC Women's Health |
| spelling | doaj.art-258b18be2eca4cb3bee9910a2e6feeb42022-12-21T22:22:56ZengBMCBMC Women's Health1472-68742017-07-011711810.1186/s12905-017-0402-2Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocolAnne-Lotte W. M. Coolen0Mèlanie N. van IJsselmuiden1Anique M. J. van Oudheusden2J. Veen3Hugo W. F. van Eijndhoven4Ben Willem J. Mol5Jan Paul Roovers6Marlies Y. Bongers7Department of Obstetrics and Gynaecology, Máxima Medical Centre VeldhovenDepartment of Gynaecology and Obstetrics, Isala ZwolleDepartment of Obstetrics and Gynaecology, Máxima Medical Centre VeldhovenDepartment of Obstetrics and Gynaecology, Máxima Medical Centre VeldhovenDepartment of Gynaecology and Obstetrics, Isala ZwolleDepartment of Gynaecology and Obstetrics, The Robinson Research Institute | School of Paediatrics and Reproductive Health, University of AdelaideDepartment of Gynaecology and Obstetrics, Academic Medical Centre AmsterdamDepartment of Obstetrics and Gynaecology, Máxima Medical Centre VeldhovenAbstract Background Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic sacrocolpopexy as the treatment of vaginal vault prolapse. Methods We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included. Discussion The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse. Trial registration Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013.http://link.springer.com/article/10.1186/s12905-017-0402-2Laparoscopic sacrocolpopexyLaparoscopic sacral colpopexyPelvic organ prolapseVaginal sacrospinous ligament fixationVaginal sacrospinous suspensionVault prolapse |
| spellingShingle | Anne-Lotte W. M. Coolen Mèlanie N. van IJsselmuiden Anique M. J. van Oudheusden J. Veen Hugo W. F. van Eijndhoven Ben Willem J. Mol Jan Paul Roovers Marlies Y. Bongers Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol BMC Women's Health Laparoscopic sacrocolpopexy Laparoscopic sacral colpopexy Pelvic organ prolapse Vaginal sacrospinous ligament fixation Vaginal sacrospinous suspension Vault prolapse |
| title | Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol |
| title_full | Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol |
| title_fullStr | Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol |
| title_full_unstemmed | Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol |
| title_short | Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol |
| title_sort | laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse a randomized controlled trial salto 2 trial study protocol |
| topic | Laparoscopic sacrocolpopexy Laparoscopic sacral colpopexy Pelvic organ prolapse Vaginal sacrospinous ligament fixation Vaginal sacrospinous suspension Vault prolapse |
| url | http://link.springer.com/article/10.1186/s12905-017-0402-2 |
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