Vaginal Adventitia Reserved and Anatomical Implant Technique of Transvaginal Mesh Procedure for Pelvic Organ Prolapse: 13-year Surgical Results With 589 Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 589
- 试验地点
- 1
- 主要终点
- Female Sexual Function Index (FSFI) scores
研究概览
简要总结
After obtaining an institutional ethics approval (#2021833), the investigators retrospectively reviewed patients with Pelvic organ prolapse (POP) who underwent Transvaginal Mesh (TVM) in their hospital during June 2008 and December 2020. The goal of this observational study is to introduce the Vaginal Adventitia Reserved and Anatomical Implant Technique in Transvaginal mesh surgery, and to report long term efficacy and safety results of this technique. The main questions it aims to answer are:
- How to reduce the potential risk of mesh-related complications when performing TVM?
- How effective is the use of the Vaginal Adventitia Reserved and Anatomical Implant Technique when performing TVM? Participants will be asked to fill the Pelvic Floor Distress Inventory (PFDI-20) at final follow-up, and the Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications.
详细描述
Patients and materials The investigators retrospective reviewed consecutive patients with stage II to IV Pelvic organ prolapse (POP) who underwent Transvaginal Mesh (TVM) at their center from June 2008 to December 2020. The Vaginal Adventitia Reserved and Anatomical Implant Technique was performed on all patients. Informed consent was obtained from all included patients. Approval was obtained from the institutional ethics committee of our hospital (West China Hospital, Sichuan University).
The pre-cut mesh kits including Gynecare Prolift® (Ethicon, Sommerville, NJ, USA), Perigee (AMS, Minnetonka, MN, USA), and Gynecare Prosima® (Ethicon, Sommerville, NJ, USA) and self-cut mesh Gynemesh (Ethicon, Sommerville, NJ, USA) were applied for transvaginal mesh repair in this study. Surgery was performed by an experienced surgeon (Dr. HS), utilizing the vaginal adventitia reserved and anatomical implant technique.
Outcome measures The effect of operation was assessed using both objective and subjective measures. The objective assessment (anatomic assessment) of success was that the nadir of prolapse never reached the point 0 (the level of hymen). The subjective assessment of success was the absence of prolapse symptoms. Chinese version of the Pelvic Floor Distress Inventory (PFDI-20) was also utilized for assessing the outcomes. Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications.
Data analysis Statistical analysis was performed via the commercially available statistical package (SPSS) 22.0 for Windows (SPSS, Chicago, IL, USA). Categorical variables were represented using frequency and percentages and compared using the chi-square test. Continuous variables in accord with normal distribution were described using means and standard deviations (SDs) and analyzed using the Student's t-test. Statistical significance was defined at P < 0.05.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >18 yr
- •Clinical diagnosis of pelvic organ prolapse
- •Pelvic organ prolapse-quantification (POP-Q) > II stage
- •Patients underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique
排除标准
- •Patients who refused to participate in the study.
结局指标
主要结局
Female Sexual Function Index (FSFI) scores
时间窗: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
FSFI was used to assess the sexual function, which was a validated questionnaire comprised of 19 items. FSFI's total score ranged from 2 to 36; the higher the score, the severer the sexual dysfunction.
complication
时间窗: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications
Pelvic Organ Prolapse-Quantification (POP-Q) scores
时间窗: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
The POP-Q system was used to assess the pelvic organ prolapse
Pelvic Floor Distress Inventory (PFDI-20) scores
时间窗: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
The PFDI-20 was used to assess pelvic floor symptoms and associated bother and has 3 subscales: the pelvic organ prolapse distress inventory (POPDI)(0-300); the colorectal-anal distress inventory (CRADI)(0-400); and the urinary distress inventory (UDI)(0-300). Higher scores indicted greater symptom bother.
次要结局
未报告次要终点