Comparison of Pectopexy Operations With and Without Mesh Use After Laparoscopic Hysterectomy for Pelvic Organ Prolapse.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Apical descensus relapse rate
研究概览
简要总结
Genital apical prolapse refers to the descent of the vaginal apex, uterus, or cervix, and surgical treatment is required for adequate apical support. Laparoscopic pectopexy is a surgical method developed as an alternative to the gold standard, sacrocolpopexy, in the treatment of genital organ prolapse, especially for obese patients for whom dissection is difficult. The vaginal cuff is attached to the pectineal ligament with polypropylene mesh in the standard technique. The use of mesh is subject to serious restrictions due to complications such as mesh erosion. Surgical methods without using a mesh may be safer treatment options for patients with genital prolapse. This study aimed to compare the results of Laparoscopic Pectopexy surgery with and without the use of mesh material after hysterectomy.
详细描述
After ethics committee approval, patients with stage 2 and above pelvic organ prolapse according to the POP-Q staging system, who have completed their fertile period and do not want uterus preservation, will be included in the study. The stage of prolapse according to POP-Q and other gynecological examination findings will be recorded at the initial examination. Prolapse and its impact on the quality of life will be recorded preoperatively and 12 months postoperatively with the Prolapse Quality of Life Questionnaire (P-QOL). Patients will be called for examination 12 months after the operation. The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system is the main outcome of the study.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients older than 40 years and younger than 80 years old with symptomatic uterine prolapse
- •Patients who provided written consent for the surgical procedure
- •Patients who do not wish to preserve their uterus
排除标准
- •Patients who cannot obtain anesthesia approval for laparoscopic surgery
- •Patients who have a confirmed or suspected pregnancy
- •Patients who have abnormal uterine/cervical/vaginal bleeding
- •Patients with biopsy-confirmed endometrial hyperplasia or cervical dysplasia
- •Patients with pathology-confirmed genital cancer
- •Patients undergone chemotherapy or radiotherapy for any type of cancer
研究组 & 干预措施
Laparoscopic Pectopexy without mesh
In this group of patients, the Laparoscopic Pectopexy operation will be performed without the use of mesh material after hysterectomy. Not using mesh will be protective against possible erosion reactions that may develop in the postoperative period. Laparoscopic hysterectomy is performed using the standard procedure with a uterine manipulator; after sealing the uterine arteries, the vagina is cut at the level of the uterine manipulator cuff and sutured. The vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture.
干预措施: Meshless Laparoscopic Pectopexy (Procedure)
Laparoscopic Pectopexy with mesh
In this group of patients, the Laparoscopic Pectopexy operation will be performed using mesh material after hysterectomy. Laparoscopic hysterectomy is performed using the standard procedure with a uterine manipulator; after sealing the uterine arteries, the vagina is cut at the level of the uterine manipulator cuff and sutured. The vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh.
干预措施: Laparoscopic Pectopexy with mesh (Procedure)
结局指标
主要结局
Apical descensus relapse rate
时间窗: 12 months after surgery
The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
次要结局
- Prolapse Quality of Life (P-QOL)(Preoperative day and 12 months after surgery)
研究者
Şener Gezer
Şener Gezer, MD, Associate Prof., Principal Investigator, Kocaeli University, School of Medicine, Department of Obstetrics and Gynecology
Kocaeli University