Post-hysterectomy Vaginal Cuff Prolapse Repair
ConditionVaginal Cuff Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKanuni Sultan Suleyman Training and Research Hospital
About this trial
This study is a randomized controlled trial comparing two minimally invasive surgeries-laparoscopic lateral suspension and laparoscopic sacrocolporopexy-for women who develop vaginal cuff prolapse after hysterectomy. Vaginal cuff prolapse occurs when the top of the vagina loses support after the uterus is removed, which can cause discomfort, bulging, or urinary and bowel problems.
The goal of this study is to determine which surgical approach is safer, more effective, and improves quality of life for patients. Women enrolled in the trial will be randomly assigned to one of the two surgeries, and outcomes such as prolapse recurrence, complications, recovery time, and patient satisfaction will be carefully monitored.
By comparing these two techniques, this study aims to provide clear guidance for surgeons and patients to make informed decisions about the best surgical treatment for post-hysterectomy vaginal cuff prolapse.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Laparoscopic Lateral Suspension
Procedure/SurgeryParticipants in this arm will undergo laparoscopic lateral suspension for post-hysterectomy vaginal cuff prolapse. The procedure involves attaching a synthetic mesh from the vaginal cuff to the lateral abdominal wall to provide support and restore normal vaginal anatomy. Standard perioperative care, including anesthesia and postoperative pain management, will be provided.
Laparoscopic Sacrocolpopexy
Procedure/SurgeryParticipants in this arm will undergo laparoscopic sacrohysteropexy for post-hysterectomy vaginal cuff prolapse. The procedure involves suspending the vaginal cuff to the sacral promontory using a synthetic mesh, restoring vaginal support. Standard perioperative care, including anesthesia and postoperative pain management, will be provided.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Laparoscopic SacrocolpopexyActive comparator 1 intervention
Group B: Laparoscopic Lateral SuspensionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Anatomical Success (Point C of POP-Q System)
Vaginal cuff support measured objectively using POP-Q system, focusing on point C (position of the vaginal apex relative to the hymen). Success is defined as point C remaining above the hymen at follow-up by a blinded examiner.
Time frame
12 months post-surgerySecondary outcomes
1
Operative Time
Total duration of the surgery measured in minutes from incision to closure.
Time frame
During surgery2
Postoperative Hospital Stay
Length of hospital stay in days from surgery to discharge.
Time frame
From the day of surgery through hospital discharge (an expected average of 2 days)3
Postoperative Complications
Includes mesh exposure, infection, bleeding, urinary or bowel injury, and reoperation.
Time frame
Up to 12 months post-surgery4
Pelvic Floor Distress Inventory (PFDI-20)
Patient-reported measure of prolapse, urinary, and bowel symptoms. The PFDI-20 consists of 3 subscales: Pelvic Organ Prolapse Distress Inventory (POPDI-6) Colorectal-Anal Distress Inventory (CRADI-8) Urinary Distress Inventory (UDI-6) Each subscale is scored 0-100, and the total score is the sum of the three subscales (0-300). 0 = no pelvic floor-related distress at all. 300 = the maximum possible distress, meaning the respondent endorsed the highest level of bother on all 20 items.
Time frame
Preoperative and 12 months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Kanuni Sultan Suleyman Training and Research Hospital
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Sponsor institution
Source ClinicalTrials.gov