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Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms

A

Ataturk University

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Procedure: uterosacral ligaments plication operation.
Procedure: pectopexy operation

Study type

Interventional

Funder types

Other

Identifiers

NCT04508062
B.30.2.ATA.0.01.00/6

Details and patient eligibility

About

The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

Full description

In this study, the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

Enrollment

38 patients

Sex

Female

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with stage II-IV apical compartment defect according to the POP-Q classification

Exclusion criteria

  • having severe chronic disease that makes the operation dangerous
  • patients under 25 and patients over 75 years old

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

38 participants in 2 patient groups

pectopexy group
Active Comparator group
Description:
this group will only have pectopexy operation
Treatment:
Procedure: pectopexy operation
Pectopexy and uterosacral ligaments plication group
Active Comparator group
Description:
this group will have pectopexy operation with bilateral uterosacral ligaments plication
Treatment:
Procedure: uterosacral ligaments plication operation.
Procedure: pectopexy operation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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