Clinical Trials Logo
  1. Home
  2. Prolapse
  3. NCT04072588
  4. Details
NCT04072588 Clinical Trial

Sacrospinous Ligament Fixation and Lateral Suspension Operations

Prolapse Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04072588
Other study ID # 2019.04.110
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 24, 2019
Est. completion date August 24, 2023

Study information
Verified date November 2022
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 80
Est. completion date August 24, 2023
Est. primary completion date August 24, 2021
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Kanuni Sultan Süleyman Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary recurrence 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		 1 years
Primary complications 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		 1 years
See also
  Status Clinical Trial Phase
Completed NCT03609229 - Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse N/A
Completed NCT04523298 - Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse N/A
Completed NCT04275089 - Early Feasibility Study of the Reia Vaginal Pessary N/A
Recruiting NCT01608568 - Affixing Polypropylene Mesh Using Barbed Suture (Quill™ SRS) During Robotic Assisted Laparoscopic Sacrocolpopexy N/A
Completed NCT01551992 - Affixing Polypropylene Mesh Using Barbed Suture (Quill™ Srs) During Laparoscopic Sacrocolpopexy Randomized Controlled Trial (Quill Lsc) N/A
Completed NCT03307824 - Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy N/A
Recruiting NCT04010292 - Enhancing Patient Recall in Urogynecologic Surgery N/A
Completed NCT03400007 - Clinical and Dynamic Floor MRI Evaluation Before and After Prolapse Surgery
Terminated NCT00099372 - Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
Recruiting NCT05964881 - PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy N/A
Completed NCT03890471 - Telephone Intervention to Increase Patient Preparedness and Satisfaction Trial (TIPPS): A Randomized Control Trial N/A
Recruiting NCT04440475 - Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy N/A
Active, not recruiting NCT04410393 - Sacrocolpopexy and Lateral Suspension Operations
Completed NCT03624764 - Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL) N/A
Completed NCT03820089 - Evaluation of TP US in Women With Prolapse
Completed NCT01779544 - Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention N/A
Completed NCT00271102 - Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder N/A
Completed NCT05474495 - Transversus Abdominis and Pelvic Floor Muscle Strengthening Exercise Program In Patients With Grade 1 Cystocele N/A
Withdrawn NCT00827645 - Uterine Artery Embolization and Pelvic Floor Symptoms
Completed NCT01805310 - Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy Phase 4