Sacrocolpopexy and Lateral Suspension Operations

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04410393
Collaborator
(none)
80
1
24
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: vaginal cuff prolapse surgery

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of the Sacrocolpopexy Operation and Lateral Suspension Operations Performed in the Treatment of Vaginal Cuff Prolapse in Patients With Hysterectomized Patients
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
sacrocolpopexy patients

Patients who underwent sacrocolpopexy for the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes

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

lateral suspension surgery patients

Patients who underwent lateral suspension surgery for vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes

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

Outcome Measures

Primary Outcome Measures

  1. recurrence [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 [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.)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kanuni Sultan Süleyman Training and Research Hospital Istanbul Turkey 33404

Sponsors and Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pınar Kadirogulları, Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04410393
Other Study ID Numbers:
  • ATADEK- 2020/06
First Posted:
Jun 1, 2020
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pınar Kadirogulları, Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2021