Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations

NCT ID: NCT06341088

Last Updated: 2025-07-17

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-05

Study Completion Date

2025-02-05

Brief Summary

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The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.

Detailed Description

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The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.Computerized random number table will be used as randomization method. Patients who agree to participate in the study and fulfill the inclusion criteria will be evaluated on the effects of prolapse on quality of life and sexual function before and after the surgical procedures and their complaints and satisfaction will be questioned. Surgical success and complications will be evaluated. Changes in the level of prolapse will be evaluated.

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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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unilateral suture sacro-hysteropexy

patients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament.

Group Type ACTIVE_COMPARATOR

unilateral suture sacro-hysteropexy

Intervention Type PROCEDURE

patients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament.

bilateral suture sacro-hysteropexy

patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable sutures and bilaterally suspended to the anterior longitudinal ligament.

Group Type ACTIVE_COMPARATOR

bilateral suture sacro-hysteropexy

Intervention Type PROCEDURE

patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable suture and bilaterally suspended to the anterior longitudinal ligament.

Interventions

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unilateral suture sacro-hysteropexy

patients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament.

Intervention Type PROCEDURE

bilateral suture sacro-hysteropexy

patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable suture and bilaterally suspended to the anterior longitudinal ligament.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients between the ages of 18-60
2. No previous prolapse surgery
3. Not having a chronic disease
4. Having stage 3-4 prolapse

Exclusion Criteria

1. Outside the age range of 18-60 years
2. Previous prolapse surgery
3. Having early stage (1-2) prolapse
4. History of chronic disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Gamze Nur Cimilli Şenocak

associate 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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Atatürk University

Erzurum, Palandöken, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B.30.2.ATA.0.01.00/132

Identifier Type: -

Identifier Source: org_study_id

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