Post-Hysterectomy Vaginal Length: Horizontal vs. Vertical Closure

NCT ID: NCT07067645

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-03-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Horizontal Vaginal Cuff Closure

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.

Group Type: ACTIVE_COMPARATOR

Horizontal Vaginal Cuff Closure Technique

Intervention Type: 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.

Vertical Vaginal Cuff Closure

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.

Group Type: ACTIVE_COMPARATOR

Vertical Vaginal Cuff Closure Technique

Intervention Type: 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.

Interventions

Horizontal Vaginal Cuff Closure Technique

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.

Intervention Type: PROCEDURE

Vertical Vaginal Cuff Closure Technique

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Serkan Kumbasar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yagmur acıyiyen, md

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Training and Research Hospital

Locations

Gaziosmanpaşa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

serkan kumbasar, md

Role: CONTACT

drserkankumbasar@gmail.com

+90 5067873216

ecenur çelikoğlu, md

Role: CONTACT

ecenurcelikoglu14@gmail.com

+90 538 549 2848

Facility Contacts

Serkan kumbasar, Assistant Professor

Role: primary

drserkankumbasar@hotmail.com

5067873216

Other Identifiers

gopvaginallength

Identifier Type: -

Identifier Source: org_study_id