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Cross-sectional study to assess the prevalence of vaginal vault prolapse after laparoscopic hysterectomy as a long-term complication.

Pelvic Organ Prolapse after laparoscopic Uterus extirpation: Postoperative long-term complication?

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20485
Enrollment
900
Registered
2016-11-09
Start date
2017-02-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

pelvic organ prolapse, vaginal vault prolapse, prolapse after hysterectomy bekkenbodemklachten, prolapsklachten na hysterectomie

Interventions

- Questionnaire: PFDI-20 (pelvic floor distress inventory), validated in Dutch population. This questionnaire entails questions on pelvic floor problems and/or discomfort within the last three months.

Sponsors

Afdeling Gynaecologie Maxima Medisch Centrum, Veldhoven
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Women with laparoscopic or vaginal hysterectomy between 1996-2004 - Hysterectomy for benign indication - Women who are still alive and mobile - Women who are aged under 80 years - Women who understand the Dutch language

Exclusion criteria

Exclusion criteria: - Subtotal or abdominal hysterectomy - Hysterectomy for malignant disease - Women who have passed away - Women who are aged 80 years or older - Women who do not understand the Dutch language

Design outcomes

Primary

MeasureTime frame
- Incidence of anatomic vault prolapse ¡Ý stage II - Incidence of symptomatic vault prolapse (¡Ý stage II + sensation of a bulge) - Incidence of asymptomatic and treated vault prolapse (conservative and surgical) Same for prolapse in anterior and posterior compartment

Secondary

MeasureTime frame
- Incidence of conservative treatment for POP: pelvic floor exercise, vaginal pessary - Incidence of POP surgery: pelvic floor repair (anterior repair, posterior repair, vaginal vault lift by sacrospinous fixation or sacral colpopexy. - POP symptoms using PFDI-20 questionnaire (Pelvic Floor Distress Inventory) - POP-Q values

Contacts

Public ContactJoggem Veen

Maxima Medisch Centrum

popup@mmc.nl / j.veen@mmc.nl040-888 8380

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)