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SALTO

 

Laparoscopic versus open abdominal sacral colpopexy for vaginal vault prolapse.

A comparison of quality of life and costs.

 

Go to the Salto website.

 

Background

It has been estimated that one in nine women will undergo a hysterectomy during lifetime. Up to 10% of these women will subsequently need surgical repair for vaginal vault prolapse thereafter. Sacral colpopexy is a generally applied treatment, that can be performed both laparoscopically or by laparotomy. After the laparoscopic abdominal sacral colpopexy had been reported, this procedure has gained popularity. However, the literature regarding laparoscopic sacral colpopexy is only sparse and randomised trials are lacking. The laparoscopic route might have advantage compared to the open abdominal technique in terms of post operative recovery, hospital stay and quality of life.

 

Method

Design: A randomised controlled trial with a follow-up of 1 year. This trial will be multicentered. Participating centers are: Maxima Medical Center Veldhoven, University Hospital Amsterdam and Hospital Free University Amsterdam. Participating patients complete questionnaires before surgery  and at 3 and 12 months after surgery. All patients undergo prior to surgery pelvic examination according to the recommendations of the ICS (POP-Q) and urodynamic investigation (see also interventions). At one year after surgery pelvic examination is repeated. At this visits all the extra surgical procedures and hospital stay due to recurrent prolapse or stress and faeces incontinence will be documented, as well as an evaluation of the direct and indirect costs.

 

Inclusion

All hysterectomised patients with a vaginal vault prolapse are elegible for the study.

 

Exclusion

Contraindication for surgery.

 

Outcome

Primary outcome

Disease specific quality of life.

Secondary outcome

Patients subjective satisfaction.

General quality of life

Costs

Anatomical result

           

Coordination

Dr. M.Y. Bongers, Gynaecologist, Maxima Medisch Centrum, Veldhoven.