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Clinical Trials/NCT04410393
NCT04410393
Active, not recruiting
Not Applicable

Comparison of the Sacrocolpopexy Operation and Lateral Suspension Operations Performed in the Treatment of Vaginal Cuff Prolapse in Patients With Hysterectomized Patients

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country80 target enrollmentJune 1, 2020
ConditionsProlapseCuff

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prolapse
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Enrollment
80
Locations
1
Primary Endpoint
complications
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is sacrocolpopexy and the other is lateral suspension. the investigators want to compare the results of patients undergoing these two operations. Thus, the difference between surgical methods will be investigated.

Detailed Description

Patients with symptomatic vaginal cuff prolapse will be operated; There will be two kinds of operation. After the operations, the patients will be followed up, a questionnaire will be applied to the postoperative patients and some questions will be asked. Pelvic examinations will also be performed and they will be evaluated for recurrence and complication. At the end of the study, the data of both groups will be compared and their superiority to each other will be shown.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
June 1, 2026
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pınar Kadirogulları

Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator

Kanuni Sultan Suleyman Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients who had previously undergone hysterectomy for benign causes
  • Patients with symptomatic vaginal cuff prolapse during hysterectomy follow-up
  • And for this, patients scheduled for operation

Exclusion Criteria

  • Patients with chronic diseases or medications that interfere with the operation
  • Patients with oncology operated for malignant cause
  • Non-localized patients with vaginal cuff prolapse

Outcomes

Primary Outcomes

complications

Time Frame: 1 years

Patients will be followed up for 1 year after the operation and will be evaluated for complications at 1, 6 and 12 months. bleeding ( bleeding rate will be specified in milliliters ) the risk of infection (According to the findings, there is an infection with / without infection.)

recurrence

Time Frame: 1 years

Patients will be followed up for 1 year after surgery and will be evaluated for recurrence at 1, 6 and 12 months. degree of uterine desensus cystocele and rectocele degree to be examined Recurrence rate will be defined by pelvic examination according to POP-Q scoring.

Study Sites (1)

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