Research with human participants

Overview of medical research in the Netherlands

Laparoscopic sacrocolpopexy versus open abdominal sacrocolpopexy for vaginal vault prolapse: A long term follow-up on quality of life and anatomical result

No registrations found.

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Ethical review
Not applicable
Status
Pending
Health condition type
-
Study type
Observational non invasive

ID

NL-OMON22345

Source

Nationaal Trial Register

Brief title

SALTO: Long term follow-up

Health condition

sacrocolpopexy
sacral colpopexy
pelvic organ prolapse
vault prolapse
sacrocolpopexie
prolaps
vaginatopprolaps
verzakking

Sponsors and support

Primary sponsor :
Máxima Medical Centre, Veldhoven
Source(s) of monetary or material Support :
Máxima Medical Centre, Veldhoven. Prof.dr. M.Y. Bongers

Intervention

Outcome measures

Primary outcome

The primary objective of this follow-up study is to evaluate long term outcome in terms of disease specific quality of life of the patient population of the SALTO1 trial.

Secondary outcome

The secondary objective of this follow-up study is to evaluate long term outcome in terms of patient’s subjective satisfaction, general quality of life, sexual functioning, subjective and objective recurrence, type and number of re-interventions and mesh and suture erosion in the patient population of the SALTO1 trial.

Background summary

SALTO: long term follow-up is a follow-up trial of the SALTO study. Primary outcome is disease specific quality of life. Secondary outcome is patient’s subjective satisfaction, general quality of life, sexual functioning, subjective and objective recurrence, type and number of re-interventions and mesh and suture erosion.

Study objective

Based on our primary results we do not expect anatomical difference between the two groups. However, we expect to see more erosion as compared to 1 year of follow-up.

Study design

3-10 years postoperative:

- Questionnaire

- Physical examination using POP-Q classification

Intervention

Since this is a follow-up study, no interventions will be done.
Patiente are asked to fill out a questionnaire and to come to the out patient clinic once for a physical examination using POP-Q classification.

Public
Máxima Medisch Centrum, Locatie Veldhoven,
P.O. Box 7777
Marlies Bongers
De Run 4600
Veldhoven 5500 MB
The Netherlands
+31 (0)40 8888000
m.bongers@mmc.nl
Scientific
Máxima Medisch Centrum, Locatie Veldhoven,
P.O. Box 7777
Marlies Bongers
De Run 4600
Veldhoven 5500 MB
The Netherlands
+31 (0)40 8888000
m.bongers@mmc.nl

Inclusion criteria

- All patients from the original SALTO trial.

- Willing to participate

Exclusion criteria

- Died patients

- Unwilling to participate.

- Unable to visit the outpatient clinic.

Design

Study type :
Observational non invasive
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Pending
Start date (anticipated) :
Enrollment :
74
Type :
Anticipated

Not applicable
Application type :
Not applicable

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL5964
NTR-old NTR6330
Other 60618 : ABR

Summary results

Coolen A-LWM, van Oudheusden AMJ, Bongers MY, et al. A Comparison of Complications between Open Abdominal Sacrocolpopexy and Laparoscopic Sacrocolpopexy for the Treatment of Vault Prolapse. Obstetrics and Gynecology International. 2013;2013:528636. doi:10.1155/2013/528636.