Rectal prolapse, pelvic organ prolapse
Conditions
Interventions
Robot-assisted laparoscopic ventral mesh rectopexy (RVMR)
Sponsors
Meander Medical Center, Amersfoort, The Netherlands
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in pain intensity in the lower back, the lower abdomen and/or the pelvic floor before and six months after RVMR. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess differences in quality of pain. - To assess the impact of pain on daily activities. - To investigate if the following parameters are associated with the development of pain after VMR: o The position of the tackers intended on the promontory and the development of new-onset (or worsened) chronic pain in the lower back. o Concomitant sacrocolpopexy o Present complaints of OD o BMI o Comorbidities o Other chronic pain o Emotional functioning | — |
Contacts
Public ContactEmma van der Schans
Meander Medisch Centrum
Outcome results
None listed