SUperiority of Perineoplasty as concomitant surgical procedure during Pelvic Organ prolapse Repair: a comparative cohort Trial (SUPPORT)
Recruiting
- Conditions
- prolapse10029903
- Registration Number
- NL-OMON51797
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 288
Inclusion Criteria
Patients >18 years indicated for vaginal POP surgery
Inlcusion criteria:
1. Female patient> 18 years of age
2. Complaints of pelvic organ prolapse
3. Indication for vaginal native tissue prolapse surgery (level I and/or level
II repair)
4.Genital hiatus (GH) according to POP-Q staging of >=4 cm and <=7 cm
Exclusion Criteria
1. Unable to understand the Dutch language
2. Pregnancy at baseline or intendancy to become pregnant during the study
period
3. Patients with previous surgery for POP (previous mid urethral sling
operation for stress urinary incontinence not excluded)
4. Unwilling to participate in the study and/or incapable of giving informed
consent
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Outcome: Surgical success, which is a composite outcome defined as<br /><br>meeting the 3 following conditions: [1] *much improved* or *improved* in<br /><br>response to the patient global impression of improvement questionnaire, [2] no<br /><br>re-intervention performed in the same compartment within the first 12 months<br /><br>after index surgery, [3] no stage 2 or more POP in the operated compartment<br /><br>Secondary outcomes: Morbidity: complications and re-interventions due to<br /><br>complications</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes: Morbidity: complications and re-interventions due to<br /><br>complications, pain. Effectiveness: disease specific and general quality of<br /><br>life. Anatomical outcomes. Societal costs.</p><br>