Laparoscopic versus open abdominal sacral colpopexy for vaginal vault prolapse.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28743

Enrollment

Registered

2012-02-07

Start date

2007-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Vault Prolapse Sacral colpopexy Laparoscopis sacral colpopexy Abdominal sacral colpopexy Topprolaps Sacrocolpopexie Laparoscopische sacropexie Laparotomische sacropexie

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 vagi

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Disease specific quality of life.	—

Secondary

Measure	Time frame
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; 3. Costs; 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.	—

Measure

Time frame

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; 3. Costs; 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.

—

Contacts

Public ContactA.L.W.M. Coolen

Polikliniek gynaecologie, tav A.Coolen Postbus 7777

a.coolen@mmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)