An interventional study of sacrocolpopexy in Pelvic Organ Prolapse, sponsored by University Of Perugia. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by University Of Perugia · Not applicable, Interventional, and Treatment
The aim of the study is to perspectively compare the anatomical and functional outcomes of Pelvic Organ Prolapse (POP) repair after Laparoscopic or Robotic-assisted Colposacropexy.
Female pelvic floor disorders rank amongst the most common disorders affecting women and include conditions such as urinary incontinence and pelvic organ prolapse (POP). POP is estimated to affect 30% of women aged 50- 89 years, and the lifetime risk of requiring surgery is 11%. Open abdominal sacrocolpopexy is the established gold standard procedure and is indicated when there is prolapse of the anterior and/or apical vaginal wall compartments. Laparoscopic sacrocolpopexy (LSCP) has not been widely adopted as it demands skill and motivation and it is associated with a long learning curve. So the hypothesis is that robot-assisted laparoscopic approach for sacrocolpopexy (RALSCP) could be an alternative to a pure laparoscopic technique.
In the study design 62 patients will be randomly enrolled (31 in the laparoscopic arm and 31 in the robotic assisted one). The primary outcome will be the anatomic one, secondary outcomes will be functional in terms of storage or voiding dysfunctions, sexual dysfunctions, bowel dysfunctions, QoL, post operative complications.
For continuous variables will be used the Mann-Withney test, for categorical data will be used McNemar test and X2 test.
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's planned enrollment of 62 is below the median of 74 across 435 interventional studies indexed under Prolapse.
Browse Prolapse studies →University Of Perugia is the lead sponsor of 51 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The surgical technique will be the same between the two approaches, in this arm the approach will be laparoscopic
Procedure: sacrocolpopexy
The surgical technique will be the same between the two approaches, in this arm the approach will be robotic assisted
Procedure: sacrocolpopexy
Peritoneal incision from the sacral promontory to the Pouch of Douglas. After careful dissection of the inter-rectovaginal space, a two-piece Y-shaped polypropylene mesh was fixed posteriorly to the levator ani muscles using a absorbable suture. The midpoint of the mesh is anchored to the posterior wall of the vagina. The anterior portion of mesh was then introduced and fixed within the intervesico- vaginal space to the anterior/apical vaginal wall with a running suture. The tails of both meshes were fixed to the sacral promontory with a strong non-absorbable polypropylene suture. The peritoneal incision was re- approximated with a running absorbable suture
Anatomical outcome
POP \<2 according to POP-Q system
Time frame: 12 months
Intraoperative ando post operative complications
Clavien-Dindo classification of surgery complications
Time frame: during surgery and within 90 days after surgery
post operative pain
VAS score (Visual Analog Pain Scale)
Time frame: within 7 days after surgery
voiding and storage symptoms
fill in Urinary Distress Inventory short form (UDI-6) to assess urinary symptoms
Time frame: 2, 6, 12 months after surgery
sexual dysfunctions
fill in Female Sexual Function Index questionnaire (FSFI)
Time frame: 2, 6, 12 months after surgery
patient satisfaction
fill in Patient Global Impression of Improvement (PGI-I)
Time frame: 12 months after surgery
Quality of life
fill in Incontinence Impact Questionnaire-Short form (IIQ-7)
Time frame: 2, 6, 12 months
Plan to share: No
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Of Perugia