Investigation of the Effect of Horizontal and Vertical Vaginal Cuff Closure on Postoperative Total Vaginal Length in Patients Undergoing Vaginal Hysterectomy and Lateral Suspension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Pelvic Organ Prolapse Quantification (POP-Q) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Horizontal Vaginal Cuff Closure Technique (Procedure)
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.
干预措施: Vertical Vaginal Cuff Closure Technique (Procedure)
结局指标
主要结局
Pelvic Organ Prolapse Quantification (POP-Q) Score
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Serkan Kumbasar
Associate Professor
Gaziosmanpasa Research and Education Hospital