Clinical trial NCT03445442: Different Surgical Techniques Used for Prolapse Repair in Elderly Patient
Official title: Different Surgical Techniques Used for Prolapse Repair in Elderly Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unrecognized Condition
Keywords: Elderly
Native tissue repair
Pelvic Organ Prolapse
Sacrocolpopexy
Vaginal mesh repair
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 214
Sex: FEMALE
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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)

Primary outcomes:
measure: Post-operative complications
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Anatomical success rate
timeFrame: 12 months follow-up
measure: Surgical satisfaction
timeFrame: 12 months follow-up
Other outcomes:
Locations:
Study officials:
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