Biological OviTex versus synthetic graft in robotic prolapse surgery: a multicentre, phase II-III, partially randomized patient preference trial
- Conditions
- intussusceptionRectal prolapse10017998
- Registration Number
- NL-OMON54397
- Lead Sponsor
- Meander Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 184
Inclusion Criteria
Indication for ventral mesh rectopexy with or without sacrocolpopexy
Informed consent for OviTex or Polypropylene
Age of 18 years or older
Able to complete questionnaires and outpatient visits
Exclusion Criteria
Mental incompetence
Allergy to ovine rumen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Study parameters/endpoints<br /><br>Main study parameter/endpoint phase II<br /><br>- Post-operative morbidity measured by reoperations, reinterventions,<br /><br>re-admissions, serious adverse events, Clavien Dindo classification and CTS<br /><br>classification.<br /><br>- The rate of rectal prolapse recurrence and complications (complaints,<br /><br>physical examination, addition research, re-operation and readmission).<br /><br><br /><br>Main study parameter/endpoint phase III<br /><br>Constipation, incontinence and urogenital functioning (questionnaire, validated<br /><br>scoring system: Fecal Incontinence Severity Index (FISI), Altomare obstructive<br /><br>defecation score (ODS)) and Pelvic Floor Distress Inventory-20 (PFDI-20).</p><br>
- Secondary Outcome Measures
Name Time Method