Sacrospinous Ligament Fixation and Lateral Suspension Operations

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04072588

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

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 transvaginal sacrospinous ligament fixation 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
Prolapse Cuff	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 [Patient Registry]

Actual Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Comparison of Transvaginal Sacrospinous Ligament Fixation and Lateral Suspension Operations in the Treatment of Vaginal Cuff Prolapse in Hysterectomized Patients

Actual Study Start Date :

Aug 24, 2019

Actual Primary Completion Date :

Aug 24, 2021

Anticipated Study Completion Date :

Aug 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Sacrospinous Ligament Fixation patients Patients who underwent Sacrospinous Ligament Fixation 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

Arm

Intervention/Treatment

Sacrospinous Ligament Fixation patients

Patients who underwent Sacrospinous Ligament Fixation 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

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
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 the risk of infection and recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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, Kanuni Sultan Suleyman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04072588

Other Study ID Numbers:

2019.04.110

First Posted:

Aug 28, 2019

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prolapse

Study Results

No Results Posted as of Oct 26, 2021