No registrations found.
ID
Source
Brief title
Health condition
Rectal prolapse, pelvic organ prolapse
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
- 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
Background summary
A proportion of the patients treated with (robot-assisted) ventral mesh rectopexy ((R)VMR) complain of postoperative chronic pain in the lower back, the lower abdomen and/or the pelvic floor. The number of patients that suffers from these symptoms however is still unknown. VMR related pain could in theory be caused by tacking the mesh to the promontory, by inserting a foreign body (mesh) into the human body or by unintended effects of the surgery itself. However, a certain number of patients also experiences pain or discomfort before surgery, possibly due to mechanical stress of the prolapsing tissues or due to OD. How preoperative pain defers from pain after VMR has never been properly monitored. The objective of this study is to investigate and compare the prevalence of pain and its characteristics before and after VMR.
Study objective
We hypothesize that in the mayority of patients there will not be any difference in experienced pain between baseline and follow-up after RVMR.
Study design
baseline, 6 weeks, 3 months, 6 months
Intervention
Robot-assisted laparoscopic ventral mesh rectopexy (RVMR)
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7806 |
| Other | MEC-U (verklaard als niet-WMO plichtig) : R19.008 |