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Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

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ClinicalTrials.gov Identifier: NCT03445442
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:
The investigator aimed to compare various pelvic floor repairs in female aged from 70 to 80 years old, to see which procedure in terms of treatment-related complications of SCP, VMR and NTR by comparing the operative and functional outcomes in this patient population.

Condition or disease Intervention/treatment
Unrecognized Condition Procedure: SCP Procedure: NTR Procedure: VMR

Detailed Description:

Pelvic organ prolapse (POP) is a global health care issue that could have a significant impact on pelvic floor function and quality of life (QOL), while seldom having the potential to be life-threatening. Prevalence of POP increases with age. In women older than 80, 11% undergo a surgical procedure. The incidence of degenerative diseases and multiple co-morbidities increases with age, and advanced age is also associated with an increase in morbidity generally for gynecologic procedures. Furthermore, greater comorbidity beforehand can predispose patients to postoperative complications such as bleeding, hematoma, pain, infectious. As a result hospital stays are longer and the surgical results are compromised.

Surgical techniques should optimize functional results and minimize complications. In POP surgery, younger women are good candidates for sacrocolpopexy (SCP), because of the improved long term functional result, while women older than 80 may have a satisfactory outcome with fewer complication with a vaginal repair with mesh (VMR) or native tissue (NTR). The increasing prevalence of POP, and the increasing population of women aged 70-80 requires an evaluation of the appropriate surgical management since women in this age group may be candidates for all types of surgical repair.

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Study Type : Observational
Actual Enrollment : 214 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Different Surgical Techniques Used for Prolapse Repair in Elderly Patient
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 1, 2012
Actual Study Completion Date : April 5, 2017

Group/Cohort Intervention/treatment
Group 1
Sacrocolpopexy (SCP)
Procedure: SCP
Sacrocolpopexy (SCP) aims to secure the anterior vaginal wall, the uterus more or less the posterior vaginal wall using polypropylene prostheses and to secure them to the presacral ligament to restore the patient's anatomical features and improve pelvic symptoms

Group 2
Native tissue repair surgery (NTR)
Procedure: NTR
Native tissue repair surgery (NTR) consist of site-specific surgical repair of the existing defect (anterior and/or posterior) using non-absorbable sutures. Specifically, anterior and/or posterior colporrhaphy for cystocele and rectocele respectively after adequate hydrodissection of the vesicovaginal or rectovaginal space.

Group 3
Vaginal mesh repair surgery (VMR)
Procedure: VMR
Vaginal mesh repair surgery (VMR) is performed using a single-incision mesh system. A single vertical incision is made in the anterior and/or posterior vaginal wall. A full-thickness dissection is performed laterally and apically to the ischial spine.




Primary Outcome Measures :
  1. Post-operative complications [ Time Frame: 12 months follow-up ]
    All complications are recorded, corresponding to Clavien Dindo classification.


Secondary Outcome Measures :
  1. Anatomical success rate [ Time Frame: 12 months follow-up ]
    Assessed by recovery time and anatomical correction

  2. Surgical satisfaction [ Time Frame: 12 months follow-up ]
    Assessed by the validated Surgical Satisfaction Questionnaire (SSQ-8)



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Ages Eligible for Study:   70 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study cohort is selected from our institution. The study involves elderly females over 70 years old with advanced pelvic organ prolapse.
Criteria

Inclusion Criteria:

  • Patients with a pelvic organ prolapse
  • Patients aged between 70 and 80 years old
  • Patients with symptomatic anterior, apical and/or posterior compartment prolapse, stage 2 or greater

Exclusion Criteria:

  • Patients with a previous history of pelvic surgery for a cancer diagnosis are excluded
  • Patients with a surgical repair specific to the existing defect site (For group 2)
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03445442    
Other Study ID Numbers: URO-BASE02
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: CFU, Publication at the European Journal in February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nice:
Elderly
Native tissue repair
Pelvic Organ Prolapse
Sacrocolpopexy
Vaginal mesh repair
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical