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Active, Not Recruiting

NCT Number: NCT04410393

Sacrocolpopexy and Lateral Suspension Operations

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vaginal cuff prolapse surgery

Procedure

Different surgical methods for the treatment of vaginal cuff prolapse in patients who have previously undergone hysterectomy for benign causes

Primary outcomes

  1. 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.

  2. 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.)

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jun 1, 2020
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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