We hypothesize that in the mayority of patients there will not be any difference in experienced pain between baseline and follow-up after RVMR.
ID
Bron
Verkorte titel
Aandoening
Rectal prolapse, pelvic organ prolapse
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The difference in pain intensity in the lower back, the lower abdomen and/or the pelvic floor before and six months after RVMR.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We hypothesize that in the mayority of patients there will not be any difference in experienced pain between baseline and follow-up after RVMR.
Onderzoeksopzet
baseline, 6 weeks, 3 months, 6 months
Onderzoeksproduct en/of interventie
Robot-assisted laparoscopic ventral mesh rectopexy (RVMR)
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
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