Comparison of Laparoscopic Pectopexy with the standard Laparoscopic Sacropexy for Apical Prolapse: An exploratory randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Average placement of mesh time
研究概览
简要总结
Sacrocolpopexy isconsidered to be the gold standard surgical treatment of vaginal vaultprolapse. Abdominal and laparoscopic approaches to sacrocolpopexy are feasible,but the laparoscopic sacrocolpopexy obviates the need of large abdominalincision, and associated with minimal tissue handling, less blood loss, lesspostoperative morbidity, less pain, shorter hospital stay. Laparoscopicsacrocolpopexy is preferred than open sacrocolpopexy for apical vaginal defectin hands of expertise.
The laparoscopicpectopexy is a newer alternative of sacropexy. It was first described in 2010by Noe KG et al , especially for obese women. In laparoscopic pectopexy,mesh is fixed at bilateral ilio-pectineal ligament and the apex of vaginalvault or anterior cervical wall. The mess follows the natural anatomicalstructure (round and broad ligament) to maintain the physiological axis withoutcrossing ureter or bowel; therefore, pelvic outlet does not shrink and it fixesthe weakness using lateral parts of the ilio-pectineal ligaments on both sides.In addition, the hypogastric vessels are also a safe distance from any danger.
The aim of the present study is to compare laparoscopicpectopexy with the standard laparoscopic sacropexy in women with symptomaticapical prolapse (POP-Q >stage II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women with symptomatic apical prolapse (uterovaginal prolapse or vaginal vault prolapse) of stage 2 or greater according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
- •2.Women who agree to participate in the trial and to comply with the protocol and give their written consent for the same.
- •3.Patients who are able to communicate by telephone and answer questions.
- •4.Adequate cardio respiratory, renal and liver functions and who will be fit to undergo surgery.
排除标准
- •Prior surgeries for vaginal prolapse correction
- •Active pelvic inflammatory disease
- •Current pregnancy
- •Any contraindications against one of the surgical methods applied in the study, hence making the randomization impossible (e.g. previously identified or strongly suspected massive adhesions between sigmoid colon and presacral peritoneum.
- •History of premalignant or malignant diseases of uterus, cervix or adnexa
- •Any contraindication for laparoscopic surgery
- •Patient unfit for anaesthesia 8.
结局指标
主要结局
Average placement of mesh time
时间窗: 1 year 6 month
次要结局
- operation time, blood loss, occurrence of major complications.(Hemoglobin decline, Pain (VAS score), duration of hospital stay, onset of bowel movements, episodes of constipation, urinary retention or urgency, de novo urinary incontinence (urge or stress urinary incontinence), urinary tract infections, occurrence of de novo anterior and lateral defect, de novo cystocele, de novo rectocele, dyspareunia, mesh erosion, relapse of apical prolapse and satisfaction rate.)