Post-Hysterectomy Vaginal Length: Horizontal vs. Vertical Closure

NCT07067645 | Recruiting

• 1 other identifier: gopvaginallength
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prolapse, Vaginal; Vaginal Vault Prolapse

Keywords

Vault suspension; vaginal length

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 3 and 6 months postoperatively

Study Arms (2)

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.

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.

Procedure: Vertical Vaginal Cuff Closure Technique

Interventions

Horizontal Vaginal Cuff Closure Technique PROCEDURE

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.

Horizontal Vaginal Cuff Closure

Vertical Vaginal Cuff Closure Technique PROCEDURE

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.

Vertical Vaginal Cuff Closure

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Uterine Prolapse; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• yagmur acıyiyen, md

  Gaziosmanpasa Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

serkan kumbasar, md

CONTACT

+90 5067873216; drserkankumbasar@gmail.com

ecenur çelikoğlu, md

CONTACT

+90 538 549 2848; ecenurcelikoglu14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 16, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)