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Lateral Suspension Versus Sacral Colpopexy POP (LLS vs SCP)

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ClinicalTrials.gov Identifier: NCT03644628
Recruitment Status : Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Nikolaus Veit-Rubin, Medical University of Vienna

Brief Summary:
The aim of the study will be to compare the SCP and LLS in the management of apical prolapse at 6 weeks, 6 months, 1 year and yearly up to 2 years with the null hypothesis being that no significant differences existed between the two surgical procedures.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Laparoscopic Lateral Suspension Versus Laparoscopic Sacral Colpopexy for Anterior and Apical Prolapse: an International Multicentric Randomized Trial
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sacropexy group (SCP)
Anterior and apical repair with laparoscopic sacropexy
Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse
Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy

Experimental: Lateral suspension group (LLS)
Anterior and apical repair with laparoscopic lateral suspension
Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse
Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy




Primary Outcome Measures :
  1. Subjective cure rate of prolapse [ Time Frame: at 12 months postoperatively ]
    Provided by the patient's feeling of the "Absence of a bulge in the vagina"

  2. Objective success [ Time Frame: at 12 months postoperatively ]
    Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total


Secondary Outcome Measures :
  1. Patient global satisfaction [ Time Frame: 1, 6, 12, 24 and 60 months ]
    This will be assessed using a Visual Analogue Scale for Global Satisfaction (10=very satisfies, 0=entirely dissatisfied)

  2. Prolapse-related Quality of life [ Time Frame: 1, 6, 12, 24 and 60 months ]

    This will be assessed using a validated questionnaire (Prolapse Quality of Life questionnaire P-QoL) The questionnaire contains 9 domains. Each answer of the patient will have values that range between 1 to 4 or 1 to 5 for the 1st question only). (1 very good 4/5 very poor). There is no overall score. A symptomatic woman might have only one domain impaired and another one might have all domains impaired. We consider both of them symptomatic but in different or same aspects of quality of life. To differentiate different domains, it is important for the decision of our surgery (we will be careful in shortening and narrowing a vagina of a woman who had only a preoperative high (impaired) Personal relationships domain score and other domains in the normal range).

    This will also help us in the follow up visits.


  3. Perioperative complications [ Time Frame: perioperatively ]

    This will be assessed using the Clavien-Dindo Scale. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.

    Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.


  4. Sexual function [ Time Frame: 1, 6, 12, 24 and 60 months ]

    This will be assessed using a validated questionnaire (Prolapse/Incontinence Sexual Questionnaire-IUGA revised PISQ-IR) The PISQ-IR is a validated evaluation tool which can be used clinically as well as in research for assessment of female sexual function (FSF), in women with female pelvic floor disorders. The resultant scale is composed of six sub-scales in sexually active (SA) women and four in women who are not sexually active (NSA).

    For women who are SA, it contains 21 items covering six domains: arousal/orgasm, partner related, condition specific, global quality rating, condition impact, and desire. For women who are not SA, it contains 12 items covering four domains: condition specific, partner related, global quality, and condition impact. Each domain receives a separate score


  5. Patient satisfaction related to improvement of condition [ Time Frame: 1, 6, 12, 24 and 60 months ]
    This will be assessed using the Patient Global Impression Scale of Improvement (PGI-I) (6=very much improved condition, 1=condition worsened)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse (uterovaginal or vault prolapse)
  • Women with or without anterior compartment prolapse (point Ba -1 or more pelvic organ prolapse quantification POP-Q)
  • Women without significant posterior compartment prolapse (point Bp -1 or more pelvic organ prolapse quantification POP-Q)

Exclusion Criteria:

  • Women not eligible for surgery for medical or anesthesiological reasons
  • Inability to comprehend questionnaires
  • Inability to give informed consent
  • Inability to return for review
  • Prior laparoscopic prolapse repair
  • Prior vaginal mesh prolapse procedure
  • Vaginal length less than 6 cm.

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): NCT03644628


Contacts
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Contact: Nikolaus Veit-Rubin, MD, MBA +436645007424 nikolaus.veitrubin@gmail.com

Sponsors and Collaborators
Medical University of Vienna
Publications:

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Responsible Party: Nikolaus Veit-Rubin, Senior resident Urogynecology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03644628    
Other Study ID Numbers: LLS RCT 08/18
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical