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

A

Ataturk University

Status

Enrolling

Conditions

Pelvic Organ Prolapse

Treatments

Procedure: unilateral suture sacro-hysteropexy
Procedure: bilateral suture sacro-hysteropexy

Study type

Interventional

Funder types

Other

Identifiers

NCT06341088
B.30.2.ATA.0.01.00/132

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

unilateral suture sacro-hysteropexy
Active Comparator group
Description:
patients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament.
Treatment:
Procedure: unilateral suture sacro-hysteropexy
bilateral suture sacro-hysteropexy
Active Comparator group
Description:
patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable sutures and bilaterally suspended to the anterior longitudinal ligament.
Treatment:
Procedure: bilateral suture sacro-hysteropexy

Trial contacts and locations

1

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Central trial contact

Gamze Nur Cimilli Senocak; Yakup Kumtepe

Data sourced from clinicaltrials.gov

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