VMR-related pai
Recruiting
- Conditions
- Rectal prolapse, pelvic organ prolapse
- Registration Number
- NL-OMON26985
- Lead Sponsor
- Meander Medical Center, Amersfoort, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Age = 18 years.
-Indication for ventral mesh rectopexy (VMR) set by the treating physician in accordance to the current guidelines on rectal prolapse.
-Counselled for therapeutic options and given informed consent for robot-assisted VMR (RVMR) or RVMR combined with sacrocolpopexy.
-Written informed consent for observational data collection.
Exclusion Criteria
-Mentally incompetent patients (unable to fulfil questionnaires).
-A medical history of pelvic radiation therapy.
-Scheduled for a redo-rectopexy.
-A medical history of previously implanted pelvic floor meshes.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in pain intensity in the lower back, the lower abdomen and/or the pelvic floor before and six months after RVMR.
- Secondary Outcome Measures
Name Time Method -To assess differences in quality of pain.<br>-To assess the impact of pain on daily activities. <br>-To investigate if the following parameters are associated with the development of pain after VMR:<br>oThe position of the tackers intended on the promontory and the development of new-onset (or worsened) chronic pain in the lower back.<br>oConcomitant sacrocolpopexy<br>oPresent complaints of OD<br>oBMI <br>oComorbidities <br>oOther chronic pain <br>oEmotional functioning