Vaginal Cuff ComplicationsNCT07174921
Post-hysterectomy Vaginal Cuff Prolapse Repair
A study testing Laparoscopic Lateral Suspension and Laparoscopic Sacrocolpopexy in people with Vaginal Cuff Complications, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Cuff Complications
- What is being tested?
- Laparoscopic Lateral Suspension and Laparoscopic Sacrocolpopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2025to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥18 years.
- History of hysterectomy (any approach: abdominal, vaginal, or laparoscopic).
- Symptomatic vaginal cuff prolapse (POP-Q stage ≥ II).
- Able to provide written informed consent.
- Willing and able to comply with study procedures and follow-up visits.
Who cannot join
- Prior sacrocolpopexy or lateral suspension surgery.
- Active pelvic infection or untreated malignancy.
- Severe cardiopulmonary or systemic disease that contraindicates laparoscopic surgery.
- Known allergy to mesh materials used in the procedures.
- Inability to complete patient-reported questionnaires due to cognitive or language barriers.
- Concurrent pelvic organ prolapse requiring additional surgical repair beyond vaginal cuff suspension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Basaksehir Cam and Sakura City Hospital
Istanbul, Istanbul, 34494
Ozan Karadeniz, 05333663003, dr.ozankrdnz@gmail.com
About this study
Official title: Laparoscopic Lateral Suspension Versus Laparoscopic Sacrocolpopexy for Post-Hysterectomy Vaginal Cuff Prolapse: A Randomized Controlled 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.
Read the detailed description
This study is a randomized controlled trial (RCT) designed to compare the outcomes of two minimally invasive surgical techniques-laparoscopic lateral suspension and laparoscopic sacrocolpopexy-for the treatment of vaginal cuff prolapse following hysterectomy. Vaginal cuff prolapse occurs when the top of the vagina loses its normal support after the uterus has been removed, leading to symptoms such as a sensation of vaginal bulging, pelvic pressure, urinary or bowel dysfunction, and discomfort during daily activities or sexual intercourse.
Eligible participants are women who have previously undergone hysterectomy and are experiencing symptomatic vaginal cuff prolapse. Participants will be randomly assigned to undergo either laparoscopic lateral suspension or laparoscopic sacrocolpopexy. Both procedures are performed using minimally invasive laparoscopic techniques, which typically result in smaller incisions, less pain, and faster recovery compared to traditional open surgery.
The study will assess multiple clinical and patient-reported outcomes, including:
Anatomical success: Prevention of prolapse recurrence at follow-up visits.
Functional outcomes: Improvement in urinary, bowel, and sexual function.
Complications: Intraoperative and postoperative adverse events.
Recovery metrics: Length of hospital stay, return to daily activities, and postoperative pain.
Patient satisfaction: Quality of life and overall satisfaction with the procedure.
By conducting this study, researchers aim to provide evidence-based guidance on which surgical approach offers better long-term outcomes, fewer complications, and higher patient satisfaction. The results of this trial may help clinicians make informed decisions and improve the care of women with post-hysterectomy vaginal cuff prolapse.
- Conditions
- Vaginal Cuff Complications
- Being tested
- Laparoscopic Lateral Suspension, Laparoscopic Sacrocolpopexy
- Keywords
- prolapse, vaginal cuff, lateral suspension, sacrocolpopexy
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Lateral SuspensionProcedure or surgery
Also called Lateral Suspension (Apical Suspension)
Participants 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 SacrocolpopexyProcedure or surgery
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Sacrocolpopexy | Active comparator | Not described Receives: Procedure: Laparoscopic Sacrocolpopexy |
| Laparoscopic Lateral Suspension | Experimental | Not described Receives: Procedure: Laparoscopic Lateral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-surgery
Secondary outcomes (6)
Operative Time
Total duration of the surgery measured in minutes from incision to closure.
Measured: During surgery
Postoperative Hospital Stay
Length of hospital stay in days from surgery to discharge.
Measured: From the day of surgery through hospital discharge (an expected average of 2 days)
Postoperative Complications
Includes mesh exposure, infection, bleeding, urinary or bowel injury, and reoperation.
Measured: Up to 12 months post-surgery
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.
Measured: Preoperative and 12 months post-surgery
Pelvic Floor Impact Questionnaire (PFIQ-7)
Patient-reported measure of the impact of pelvic floor disorders on daily activities, relationships, and quality of life.
The PFIQ-7 includes 3 subscales:
Urinary Impact Questionnaire (UIQ-7)
Colorectal-Anal Impact Questionnaire (CRAIQ-7)
Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7)
Each subscale contains items scored 0-3 ("not at all" to "quite a bit"), then converted to a 0-100 scale.
The three subscales are summed for a total score ranging from 0 to 300.
0 = no impact on quality of life.
300 = maximum impact across all domains (urinary, colorectal-anal, and prolapse).
Higher scores indicate worse quality-of-life impairment due to pelvic floor disorders.
Measured: Preoperative and 12 months post-surgery
Patient Global Impression (PGI) Scale
Patient-reported scale evaluating overall improvement or satisfaction with surgery, typically rated from 1 ("very much improved") to 7 ("very much worse").
Measured: Preoperative and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Cuff ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan Karadeniz, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174921
- Sponsor's protocol ID
- CSC Hospital
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Lateral Suspension Versus Laparoscopic Sacrocolpopexy for Post-Hysterectomy Vaginal Cuff Prolapse: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07174921
- Acronym / sponsor ID
- CSC Hospital
- Conditions
- Vaginal Cuff Complications
- Keywords
- prolapse, vaginal cuff, lateral suspension, sacrocolpopexy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized controlled trial (RCT) designed to compare the outcomes of two minimally invasive surgical techniques-laparoscopic lateral suspension and laparoscopic sacrocolpopexy-for the treatment of vaginal cuff prolapse following hysterectomy. Vaginal cuff prolapse occurs when the top of the vagina loses its normal support after the uterus has been removed, leading to symptoms such as a sensation of vaginal bulging, pelvic pressure, urinary or bowel dysfunction, and discomfort during daily activities or sexual intercourse.
Eligible participants are women who have previously undergone hysterectomy and are experiencing symptomatic vaginal cuff prolapse. Participants will be randomly assigned to undergo either laparoscopic lateral suspension or laparoscopic sacrocolpopexy. Both procedures are performed using minimally invasive laparoscopic techniques, which typically result in smaller incisions, less pain, and faster recovery compared to traditional open surgery.
The study will assess multiple clinical and patient-reported outcomes, including:
Anatomical success: Prevention of prolapse recurrence at follow-up visits.
Functional outcomes: Improvement in urinary, bowel, and sexual function.
Complications: Intraoperative and postoperative adverse events.
Recovery metrics: Length of hospital stay, return to daily activities, and postoperative pain.
Patient satisfaction: Quality of life and overall satisfaction with the procedure.
By conducting this study, researchers aim to provide evidence-based guidance on which surgical approach offers better long-term outcomes, fewer complications, and higher patient satisfaction. The results of this trial may help clinicians make informed decisions and improve the care of women with post-hysterectomy vaginal cuff prolapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Sacrocolpopexy | Active comparator | Procedure: Laparoscopic Sacrocolpopexy |
| Laparoscopic Lateral Suspension | Experimental | Procedure: Laparoscopic Lateral Suspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged ≥18 years.
- History of hysterectomy (any approach: abdominal, vaginal, or laparoscopic).
- Symptomatic vaginal cuff prolapse (POP-Q stage ≥ II).
- Able to provide written informed consent.
- Willing and able to comply with study procedures and follow-up visits.
Key exclusion criteria (6 listed)
- Prior sacrocolpopexy or lateral suspension surgery.
- Active pelvic infection or untreated malignancy.
- Severe cardiopulmonary or systemic disease that contraindicates laparoscopic surgery.
- Known allergy to mesh materials used in the procedures.
- Inability to complete patient-reported questionnaires due to cognitive or language barriers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Lateral SuspensionAlso: Lateral Suspension (Apical Suspension)Participants 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. | Procedure or surgery | Laparoscopic Lateral Suspension |
| Laparoscopic SacrocolpopexyParticipants 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. | Procedure or surgery | Laparoscopic Sacrocolpopexy |
Primary outcome
Anatomical Success (Point C of POP-Q System)
Time frame: 12 months post-surgery
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.
6 secondary outcomes
Operative Time
Time frame: During surgery
Postoperative Hospital Stay
Time frame: From the day of surgery through hospital discharge (an expected average of 2 days)
Postoperative Complications
Time frame: Up to 12 months post-surgery
Pelvic Floor Distress Inventory (PFDI-20)
Time frame: Preoperative and 12 months post-surgery
Pelvic Floor Impact Questionnaire (PFIQ-7)
Time frame: Preoperative and 12 months post-surgery
Patient Global Impression (PGI) Scale
Time frame: Preoperative and 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
Related trials for Vaginal Cuff Complications
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 1/2
Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy
Pain, Postoperative
Recruiting
Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)
Gynecologic Cancers, Vaginal Cuff Dehiscence
Recruiting
Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy
Postoperative Pain
Active, not recruitingPhase 1
Frontline Immunotherapy Combined With Radiation and Chemotherapy in High Risk Endometrial Cancer
Endometrial Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Lateral Suspension and Laparoscopic Sacrocolpopexy in people with Vaginal Cuff Complications, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ozan Karadeniz, MD (+905333663003, dr.ozankrdnz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical Success (Point C of POP-Q System) (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.