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

NCT ID: NCT04508062

Last Updated: 2023-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-06

Study Completion Date

2022-03-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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pectopexy group

this group will only have pectopexy operation

Group Type ACTIVE_COMPARATOR

pectopexy operation

Intervention Type PROCEDURE

Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.

Pectopexy and uterosacral ligaments plication group

this group will have pectopexy operation with bilateral uterosacral ligaments plication

Group Type ACTIVE_COMPARATOR

pectopexy operation

Intervention Type PROCEDURE

Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.

uterosacral ligaments plication operation.

Intervention Type PROCEDURE

At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated.

Interventions

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pectopexy operation

Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.

Intervention Type PROCEDURE

uterosacral ligaments plication operation.

At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Gamze Nur Cimilli Şenocak

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gamze Nur Cimilli Senocak

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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Gamze Nur Cimilli Senocak

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B.30.2.ATA.0.01.00/6

Identifier Type: -

Identifier Source: org_study_id

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