|- candidate number||11096|
|- NTR Number||NTR3276|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-feb-2012|
|- Secondary IDs||0631 METC|
|- Public Title||Laparoscopic versus open abdominal sacral colpopexy for vaginal vault prolapse. |
|- Scientific Title||Laparoscopic versus open abdominal sacral colpopexy for vaginal vault prolapse. |
|- hypothesis||The wide variety of surgical treatments available for vaginal vault prolapse indicates the lack of consensus as to the optimal treatment. The three RCT comparing abdominal sacral colpopexy with vaginal sacrospinous fixation indicate an advantage for the abdominal technique. The laparoscopic technique has been described, but never compared in a RCT with an other technique. With the advantages of laparoscopic surgery in mind (shorted hospital stay, rapid recovery) a comparison of the abdominal sacral colpopexy and the laparoscopic sacral colpopexy is needed.|
|- Healt Condition(s) or Problem(s) studied||Pelvic organ prolapse, Laparoscopy, Abdominal surgery, Sacral colpopexy, Sacropexy, Topprolaps|
|- Inclusion criteria||All hysterectomised patients with a vaginal vault prolapse are elegible for the study. |
|- Exclusion criteria||Patients with a contraindication for a surgical intervention will be excluded. For example: patients in a bad physical condition, patients suffering from COPD etc.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2007|
|- planned closingdate||1-mei-2014|
|- Target number of participants||74|
|- Interventions||The surgical procedures that will be performed are:|
1. Laparoscopic sacral colpopexie;
2. Open abdominal sacral colpopexie.
Looking at the design of this surgical intervention, the main goal of sacrocolpopexy is to reconstitute an adequate, durable system of support and suspension vagina by replacing the impaired and/or detached native fascial tissue with a synthetic non-absorbable prosthesis.
Gynaecologists need to have performed at least twenty five procedures to exclude a learning curve. All centers will use the same mesh, the same sutures and the same technique to fix the mesh on the sacrum. This material will be used for both the interventions.
The laparoscopic sacral colpopexy will be performed with four trocards, one for the scoop and three side trocards. An anterior and a posterior mesh will be attached to the vaginal wall. Both meshes will be sutured to each other after which the posterior mesh will be fixed to the sacrum. The mesh will be peritonalized.
The open sacral colpopexy will be performed by a laparotomy. The procedure will be the same as with a closed procedure. An anterior and a posterior mesh will be attached to the vaginal wall. Both meshes will be sutured to each other after which the posterior mesh will be fixed to the sacrum. The mesh will be peritonealised.
|- Primary outcome||Disease specific quality of life.|
|- Secondary outcome||1. Patients subjective satisfaction. Satisfaction is scored on a five point scale 1 to 5. 1 is totally unsatisfied and five means very satisfied;|
2. General quality of life: At 3 and at 12 months after surgery this is measured using the SF-36;
4. Anatomical result: Pelvic examination according to the recommendations of the ICS will be performed in all patients at 6 weeks and one year after surgery.
|- Timepoints||1. Pre-operative: Medical history, questionnaire and physical examination using POP-Q classification;|
2. Peri-operative: (Post) procedure details;
3. Six week post-operative: Physical examination using POP-Q classification;
4. Six months post-operative: Questionnaire;
5. One year post-operative: Questionnaire and physical examination using POP-Q classification.
|- Trial web site||www.studies-obsgyn.nl/salto|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| A.L.W.M. Coolen|
|- CONTACT for SCIENTIFIC QUERIES|| A.L.W.M. Coolen|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|Maxima Medical Center|
|- Brief summary||SALTO is a multi centred randomized controlled trial of abdominal sacral colpopexy versus laparoscopic sacral colpopexy in patients with a vaginal vault prolapse. The primary outcome is disease specific quality of life. Secondary outcomes are general quality of life, satisfaction, anatomical results and costs. |
|- Main changes (audit trail)|
|- RECORD||7-feb-2012 - 29-apr-2017|