An observational study in Unrecognized Condition, sponsored by Centre Hospitalier Universitaire de Nice. Completed. Open to female participants aged 70 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-22.
Sponsored by Centre Hospitalier Universitaire de Nice · Observational
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.
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.
The study cohort is selected from our institution. The study involves elderly females over 70 years old with advanced pelvic organ prolapse.
Exclusion Criteria:
Sacrocolpopexy (SCP)
Procedure: SCP
Native tissue repair surgery (NTR)
Procedure: NTR
Vaginal mesh repair surgery (VMR)
Procedure: VMR
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
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.
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.
Post-operative complications
All complications are recorded, corresponding to Clavien Dindo classification.
Time frame: 12 months follow-up
Anatomical success rate
Assessed by recovery time and anatomical correction
Time frame: 12 months follow-up
Surgical satisfaction
Assessed by the validated Surgical Satisfaction Questionnaire (SSQ-8)
Time frame: 12 months follow-up
No study locations are listed for this record.
Plan to share: No — CFU, Publication at the European Journal in February 2018
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice