Prolapse, VaginalvaginaNCT07067645
Post-Hysterectomy Vaginal Length: Horizontal vs. Vertical Closure
A study testing Horizontal Vaginal Cuff Closure Technique and Vertical Vaginal Cuff Closure Technique in people with Prolapse, Vaginal and Vaginal Vault Prolapse, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study aims to evaluate the impact of vaginal cuff closure orientation-horizontal versus vertical-on postoperative total vaginal length in patients undergoing vaginal hysterectomy combined with lateral suspension. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Prolapse, Vaginal, Vaginal Vault Prolapse
- What is being tested?
- Horizontal Vaginal Cuff Closure Technique and Vertical Vaginal Cuff Closure Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Mar 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 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases with vaginal hysterectomy and lateral suspension surgery due to stage 3-4 uterine prolapse Agree to participate in the study and sign the informed consent form
Who cannot join
- Cases that have previously undergone a different suspension surgery due to descent uteri (vaginal hysterectomy and sacrospinous ligament fixation surgery, vaginal hysterectomy and sacrocolopexy surgery, vaginal hysterectomy and high sacouterin plication surgery) Cases that have undergone vaginal hysterectomy due to malignancy Cases that have undergone radiotherapy due to malignancy (brachytherapy) Patients who are not suitable for surgical intervention due to severe vaginal atrophy.
- Patients who will not be able to comply with the follow-up process. Not accepting to participate in the study or not signing the informed consent form
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
Gaziosmanpaşa Training and Research Hospital
Istanbul
Serkan kumbasar, Assistant Professor, 5067873216, drserkankumbasar@hotmail.com
About this study
Official title: Investigation of the Effect of Horizontal and Vertical Vaginal Cuff Closure on Postoperative Total Vaginal Length in Patients Undergoing Vaginal Hysterectomy and Lateral Suspension
This prospective clinical study aims to evaluate the impact of vaginal cuff closure orientation-horizontal versus vertical-on postoperative total vaginal length in patients undergoing vaginal hysterectomy combined with lateral suspension. By comparing anatomical outcomes between the two closure techniques, the study seeks to determine which method better preserves vaginal length, potentially influencing surgical preferences and postoperative quality of life.
Read the detailed description
This prospective clinical study is designed to evaluate the effect of vaginal cuff closure orientation-horizontal versus vertical-on postoperative total vaginal length in patients undergoing vaginal hysterectomy with lateral suspension. Vaginal length is a significant factor in pelvic floor support, sexual function, and patient satisfaction after pelvic organ prolapse surgeries.
Eligible patients undergoing vaginal hysterectomy and lateral suspension for uterine prolapse will be randomly assigned to two groups based on the vaginal cuff closure technique: Group 1 (horizontal closure) and Group 2 (vertical closure). All surgeries will be performed by the same surgical team to minimize technique-related variability. Preoperative and postoperative total vaginal lengths will be measured via standardized pelvic examination and recorded.
Secondary outcomes will include patient-reported symptoms (e.g., sensation of vaginal shortening, sexual function), surgical duration, intraoperative complications, and early postoperative outcomes. The study aims to provide evidence-based guidance on optimal vaginal cuff closure technique in uterovaginal prolapse surgery, with an emphasis on preserving vaginal length and improving postoperative quality of life.
- Conditions
- Prolapse, Vaginal, Vaginal Vault Prolapse
- Being tested
- Horizontal Vaginal Cuff Closure Technique, Vertical Vaginal Cuff Closure Technique
- Keywords
- Vault suspension, vaginal length
- Medical subject headings
- Uterine Prolapse, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal Vaginal Cuff Closure TechniqueProcedure or surgery
In this arm, patients undergoing vaginal hysterectomy with lateral suspension will receive horizontal closure of the vaginal cuff. After removal of the uterus, the vaginal cuff is closed in a transverse (right-to-left) direction using standard absorbable sutures. The technique aims to maintain or optimize the anatomical axis and preserve vaginal length in the horizontal plane. The entire procedure is performed under general or regional anesthesia by an experienced surgical team.
Vertical Vaginal Cuff Closure TechniqueProcedure or surgery
In this arm, patients undergoing vaginal hysterectomy with lateral suspension will receive vertical closure of the vaginal cuff. After the uterus is removed, the vaginal cuff is closed in a cranio-caudal (top-to-bottom) orientation using absorbable sutures. This technique is hypothesized to better support apical structures and reduce tissue tension. Procedures are performed under general or regional anesthesia with standardized operative technique.
| Study group | Role | What they receive |
|---|---|---|
| Horizontal Vaginal Cuff Closure | Active comparator | Patients in this group will undergo vaginal hysterectomy with lateral suspension, followed by horizontal closure of the vaginal cuff using standard suturing technique. The effect on postoperative total vaginal length will be evaluated. Receives: Procedure: Horizontal Vaginal Cuff Closure Technique |
| Vertical Vaginal Cuff Closure | Active comparator | Patients in this group will undergo vaginal hysterectomy with lateral suspension, followed by vertical closure of the vaginal cuff using standard suturing technique. Postoperative vaginal length outcomes will be compared to those of the horizontal closure group. Receives: Procedure: Vertical Vaginal Cuff Closure Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification (POP-Q) Score
POP-Q scores will be used to assess anatomical outcomes of the pelvic support structures before and after surgery. Standardized POP-Q measurements (Aa, Ba, C, D, Ap, Bp, gh, pb, tvl) will be recorded preoperatively, 3 and 6 months postoperatively by blinded examiners. The primary focus will be on point C (vaginal apex) and total vaginal length (TVL) for comparison between groups.
Measured: Baseline, 3 and 6 months postoperatively
PISQ-12 Questionnaire Score
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) will be administered to sexually active patients preoperatively, 3 and 6 months postoperatively to assess sexual function and satisfaction. Changes in the total PISQ-12 score will be analyzed between the horizontal and vertical closure groups.
Measured: Baseline, 3 and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse, VaginalStudies 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
- Model description
- This is a prospective, randomized, parallel-assignment clinical study designed to compare two surgical techniques for vaginal cuff closure-horizontal versus vertical-performed during vaginal hysterectomy with lateral suspension for uterine prolapse. Patients will be randomly assigned to one of two intervention arms, with the aim of evaluating the impact of closure orientation on total postoperative vaginal length. The study will be conducted at a single center with standardized surgical and measurement protocols, and outcomes will be assessed by blinded evaluators
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Serkan Kumbasar, Gaziosmanpasa Research and Education Hospital
- Investigators
- yagmur acıyiyen, md, Principal investigator, Gaziosmanpasa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067645
- Sponsor's protocol ID
- gopvaginallength
- Acronym
- vagina
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Horizontal and Vertical Vaginal Cuff Closure on Postoperative Total Vaginal Length in Patients Undergoing Vaginal Hysterectomy and Lateral Suspension
- ClinicalTrials.gov ID
- NCT07067645
- Acronym / sponsor ID
- vagina / gopvaginallength
- Conditions
- Prolapse, Vaginal, Vaginal Vault Prolapse
- Keywords
- Vault suspension, vaginal length
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 16 Jul 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 prospective clinical study aims to evaluate the impact of vaginal cuff closure orientation-horizontal versus vertical-on postoperative total vaginal length in patients undergoing vaginal hysterectomy combined with lateral suspension. By comparing anatomical outcomes between the two closure techniques, the study seeks to determine which method better preserves vaginal length, potentially influencing surgical preferences and postoperative quality of life.
Detailed description
This prospective clinical study is designed to evaluate the effect of vaginal cuff closure orientation-horizontal versus vertical-on postoperative total vaginal length in patients undergoing vaginal hysterectomy with lateral suspension. Vaginal length is a significant factor in pelvic floor support, sexual function, and patient satisfaction after pelvic organ prolapse surgeries.
Eligible patients undergoing vaginal hysterectomy and lateral suspension for uterine prolapse will be randomly assigned to two groups based on the vaginal cuff closure technique: Group 1 (horizontal closure) and Group 2 (vertical closure). All surgeries will be performed by the same surgical team to minimize technique-related variability. Preoperative and postoperative total vaginal lengths will be measured via standardized pelvic examination and recorded.
Secondary outcomes will include patient-reported symptoms (e.g., sensation of vaginal shortening, sexual function), surgical duration, intraoperative complications, and early postoperative outcomes. The study aims to provide evidence-based guidance on optimal vaginal cuff closure technique in uterovaginal prolapse surgery, with an emphasis on preserving vaginal length and improving postoperative quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, parallel-assignment clinical study designed to compare two surgical techniques for vaginal cuff closure-horizontal versus vertical-performed during vaginal hysterectomy with lateral suspension for uterine prolapse. Patients will be randomly assigned to one of two intervention arms, with the aim of evaluating the impact of closure orientation on total postoperative vaginal length. The study will be conducted at a single center with standardized surgical and measurement protocols, and outcomes will be assessed by blinded evaluators
| Arm | Type | Receives |
|---|---|---|
| Horizontal Vaginal Cuff Closure | Active comparator | Procedure: Horizontal Vaginal Cuff Closure TechniquePatients in this group will undergo vaginal hysterectomy with lateral suspension, followed by horizontal closure of the vaginal cuff using standard suturing technique. The effect on postoperative total vaginal length will be evaluated. |
| Vertical Vaginal Cuff Closure | Active comparator | Procedure: Vertical Vaginal Cuff Closure TechniquePatients in this group will undergo vaginal hysterectomy with lateral suspension, followed by vertical closure of the vaginal cuff using standard suturing technique. Postoperative vaginal length outcomes will be compared to those of the horizontal closure group. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cases with vaginal hysterectomy and lateral suspension surgery due to stage 3-4 uterine prolapse Agree to participate in the study and sign the informed consent form
Key exclusion criteria (2 listed)
- Cases that have previously undergone a different suspension surgery due to descent uteri (vaginal hysterectomy and sacrospinous ligament fixation surgery, vaginal hysterectomy and sacrocolopexy surgery, vaginal hysterectomy and high sacouterin plication surgery) Cases that have undergone vaginal hysterectomy due to malignancy Cases that have undergone radiotherapy due to malignancy (brachytherapy) Patients who are not suitable for surgical intervention due to severe vaginal atrophy.
- Patients who will not be able to comply with the follow-up process. Not accepting to participate in the study or not signing the informed consent form
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 |
|---|---|---|
| Horizontal Vaginal Cuff Closure TechniqueIn this arm, patients undergoing vaginal hysterectomy with lateral suspension will receive horizontal closure of the vaginal cuff. After removal of the uterus, the vaginal cuff is closed in a transverse (right-to-left) direction using standard absorbable sutures. The technique aims to maintain or optimize the anatomical axis and preserve vaginal length in the horizontal plane. The entire procedure is performed under general or regional anesthesia by an experienced surgical team. | Procedure or surgery | Horizontal Vaginal Cuff Closure |
| Vertical Vaginal Cuff Closure TechniqueIn this arm, patients undergoing vaginal hysterectomy with lateral suspension will receive vertical closure of the vaginal cuff. After the uterus is removed, the vaginal cuff is closed in a cranio-caudal (top-to-bottom) orientation using absorbable sutures. This technique is hypothesized to better support apical structures and reduce tissue tension. Procedures are performed under general or regional anesthesia with standardized operative technique. | Procedure or surgery | Vertical Vaginal Cuff Closure |
Primary outcome
Pelvic Organ Prolapse Quantification (POP-Q) Score
Time frame: Baseline, 3 and 6 months postoperatively
POP-Q scores will be used to assess anatomical outcomes of the pelvic support structures before and after surgery. Standardized POP-Q measurements (Aa, Ba, C, D, Ap, Bp, gh, pb, tvl) will be recorded preoperatively, 3 and 6 months postoperatively by blinded examiners. The primary focus will be on point C (vaginal apex) and total vaginal length (TVL) for comparison between groups.
PISQ-12 Questionnaire Score
Time frame: Baseline, 3 and 6 months postoperatively
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) will be administered to sexually active patients preoperatively, 3 and 6 months postoperatively to assess sexual function and satisfaction. Changes in the total PISQ-12 score will be analyzed between the horizontal and vertical closure groups.
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 Jul 2025.
- Individual participant dataSharing planned: No
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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.
yagmur acıyiyen, md principal investigator
Gaziosmanpasa Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horizontal Vaginal Cuff Closure Technique and Vertical Vaginal Cuff Closure Technique in people with Prolapse, Vaginal and Vaginal Vault Prolapse, run by Gaziosmanpasa Research and Education 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 1 inclusion and 2 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 Jul 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 serkan kumbasar, md (+90 5067873216, drserkankumbasar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Organ Prolapse Quantification (POP-Q) Score (time frame: Baseline, 3 and 6 months postoperatively). The study lists 2 primary outcomes in all. 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 Jul 2025.