Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Unrecognized Condition

Treatments

Procedure: VMR
Procedure: NTR
Procedure: SCP

Study type

Observational

Funder types

Other

Identifiers

NCT03445442
URO-BASE02

Details and patient eligibility

About

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.

Full 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.

Enrollment

214 patients

Sex

Female

Ages

70 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

214 participants in 3 patient groups

Group 1
Description:
Sacrocolpopexy (SCP)
Treatment:
Procedure: SCP
Group 2
Description:
Native tissue repair surgery (NTR)
Treatment:
Procedure: NTR
Group 3
Description:
Vaginal mesh repair surgery (VMR)
Treatment:
Procedure: VMR

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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