Research with human participants

Overview of medical research in the Netherlands

Laparoscopic sacrocolpopexy using bone anchor fixation in cases of vaginal vault prolapse.

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON26956

Source

NTR

Health condition

prolapse
incontinence

Sponsors and support

Primary sponsor :
Performer: Sint Franciscus Gasthuis, Rotterdam, The Netherlands.
Source(s) of monetary or material Support :
No funding

Intervention

Outcome measures

Primary outcome

Succesfull reduction of prolaps:

1. Anatomically, classification with POP-Q system;

2. In terms of patient satisfaction with validated questionnaires (Urogenital Distress Inventory (UDI), Incontinence Impact Questionnaire (IIQ) and the Defecatory Distress Inventory (DDI))11.

Secondary outcome

Urodynamic parameters and lower urinary tract symptoms.

Background summary

Application of the laparoscopic bone anchor inserter in laparoscopic sacrocolpopexy is an easy and safe procedure that provides firm fixation and excellent anatomical results. The present observational study adresses long term results and patient satisfaction and includes sequential urodynamic assessment.

Study objective

N/A

Study design

1. A minimal follow up of 6 months;

2. Urodynamic evaluation scheduled 3-6 months after surgery.

Intervention

Laparoscopic sacrocolpopexy with use of titanium bone anchor and polypropylene mesh.

Public
Department of Obstetrics and Gynecology<br>
Sint Franciscus Gasthuis<br>
Kleiweg 500
R.M.F. Weiden, van der
Rotterdam 3045 PM
The Netherlands
+31 (0)10 4616161
r.vanderweiden@sfg.nl
Scientific
Department of Obstetrics and Gynecology<br>
Sint Franciscus Gasthuis<br>
Kleiweg 500
R.M.F. Weiden, van der
Rotterdam 3045 PM
The Netherlands
+31 (0)10 4616161
r.vanderweiden@sfg.nl

Inclusion criteria

Patients with vaginal vault prolapse after a previous hysterectomy.

Exclusion criteria

1. Preceding rectosigmoid resection;

2. Extensive intraabdominal and/or pelvic adhesions.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Non controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
50
Type :
Actual

Positive opinion
Date :
Application type :
First submission

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 NL2711
NTR-old NTR2849
Other TWOR Protocol : 20004/57
ISRCTN ISRCTN wordt niet meer aangevraagd.

Summary results

Van der Weiden RMF, Withagen MIJ, Bergkamp ABM, Mannaerts GHH. A new device for bone anchor fixation in laparoscopic sacrocolpopexy. The Franciscan laparoscic bone anchor inserter. Surg Endosc 2005; 19: 594-597.