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Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair

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ClinicalTrials.gov Identifier: NCT02852512
Recruitment Status : Unknown
Verified August 2016 by Elisabetta Costantini, University Of Perugia.
Recruitment status was:  Recruiting
First Posted : August 2, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Elisabetta Costantini, University Of Perugia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: sacrocolpopexy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perspective Randomized Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Laparoscopic sacrocolpopexy
The surgical technique will be the same between the two approaches, in this arm the approach will be laparoscopic
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

Active Comparator: Robotic assisted 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




Primary Outcome Measures :
  1. Anatomical outcome [ Time Frame: 12 months ]
    POP <2 according to POP-Q system


Secondary Outcome Measures :
  1. Intraoperative ando post operative complications [ Time Frame: during surgery and within 90 days after surgery ]
    Clavien-Dindo classification of surgery complications

  2. post operative pain [ Time Frame: within 7 days after surgery ]
    VAS score (Visual Analog Pain Scale)

  3. voiding and storage symptoms [ Time Frame: 2, 6, 12 months after surgery ]
    fill in Urinary Distress Inventory short form (UDI-6) to assess urinary symptoms

  4. sexual dysfunctions [ Time Frame: 2, 6, 12 months after surgery ]
    fill in Female Sexual Function Index questionnaire (FSFI)

  5. patient satisfaction [ Time Frame: 12 months after surgery ]
    fill in Patient Global Impression of Improvement (PGI-I)

  6. Quality of life [ Time Frame: 2, 6, 12 months ]
    fill in Incontinence Impact Questionnaire-Short form (IIQ-7)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic POP >2 stage according to POP Q system

Exclusion Criteria:

  • Obesity
  • Heart failure (NYHA III-IV)
  • High stage COPD (Chronic Obstructive Pulmonary Disease)
  • Patients who underwent more than 2 previous abdominal surgical procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852512


Contacts
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Contact: Elisabetta Costantini, MD +393393384370 elisabetta.costantini@unipg.it
Contact: Ester Illiano, MD +393283620614 ester.illiano@inwind.it

Locations
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Italy
Santa Maria della Misericordia Hospital- University of Perugia Recruiting
Perugia, Italy, 06100
Contact: Elisabetta Costantini, MD    +393393384370    elisabetta.costatini@unipg.it   
Contact: Ester Illiano, MD    +393283620614    ester.illiano@inwind.it   
Sponsors and Collaborators
University Of Perugia
Investigators
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Principal Investigator: Elisabetta Costantini, MD University Of Perugia
Publications of Results:
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Responsible Party: Elisabetta Costantini, associate professor, University Of Perugia
ClinicalTrials.gov Identifier: NCT02852512    
Other Study ID Numbers: LVR1
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Elisabetta Costantini, University Of Perugia:
Laparoscopic Sacrocolpopexy
Robotic Assisted Sacrocolpopexy
Pelvic Organ Prolapse
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical