Prospective Randomized Study for Vaginal Vault Prolapse After Hysterectomy: Comparison of a Vaginal and Laparoscopic Method With Validation of Translated Questionnaire for Symptoms and Quality of Life by Vaginal Prolapse.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- anatomical failure (Failure was defined clinically as Ba, C or Bp at the hymen or below, on maximum Valsalva maneuver.)
研究概览
简要总结
The study is carried out at the Sahlgrenska University Hospital and the patient population consists of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions are either vaginal sacrospinousfixation or laparoscopic sacrocolpopexy following randomization to one of the types of surgery. The primary outcome is anatomical failure based on clinical assessment. Failure is defined clinically, according to the Pelvic Organ Prolapse Quantification system, as Ba, C or Bp at the hymen or below on maximum Valsalva maneuver one and two years after the surgery. Secondary outcomes are evaluation of continence, sexual function and prolapse symptoms based on validated questionnaires 1, 2, 5 and 10 years after the surgery.
详细描述
The lifetime risk for pelvic floor surgery for prolapse is likely to be between 10% and 15%, and a large number of patients who previously underwent hysterectomy develop vaginal vault prolapse. There is some evidence that about 2% of all women after hysterectomy would require a surgery for vault prolapse. There are many different techniques used for correction of vault prolapse but the evidence for them is lacking and the use is guided mainly by tradition at the singe institution.
There is some evidence indicating that laparoscopic surgery can be superior to the vaginal approach. Symptoms of prolapse are significantly associated with avulsion injury in patients after hysterectomy.
Our aim is to compare, with a 1- and 2-years follow-up examination in patients with post-hysterectomy prolapse, the efficacy of two standard surgical procedures for vaginal vault prolapse: sacrospinous vaginal colpopexy (the Richter procedure) with native tissue vaginal repair (sacrospinous fixation, SSF) and laparoscopic colposacropexy with mesh.
This is a single-center, randomized controlled trial of two standard surgical procedures for vaginal vault prolapse routinely used at our institution.Both procedures are designed to treat vault prolapse, one with mesh implantation through laparoscopy and the other with vaginal repairs and apical fixation to the sacrospinous ligament, usually on the right.
All patients referred to our gynecological unit (Ob/Gyn Department of Sahlgrenska University Hospital in Gothenburg) because of symptomatic vault prolapse and fulfilling the inclusions criteria are asked to participate in the study. Eligible for inclusion are: post-hysterectomy patients with at least two-compartment prolapse (with affected apical/vault compartment, stage II or higher on the Pelvic Organ Prolapse Quantification system (POP-Q)), suffering from symptoms of prolapse, requesting pelvic floor reconstructive surgery, and diagnosed with a vault prolapse. Excluded are: patients with prolapse and uterus in place, those not requesting pelvic floor surgery, patients who do not understand Swedish or are not capable to fulfill follow up procedure.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •post-hysterectomy patients with at least two-compartment prolapse (with affected apical/vault compartment,
- •stage II or higher on the Pelvic Organ Prolapse Quantification system (POP-Q)),
- •suffering from symptoms of prolapse,
- •requesting pelvic floor reconstructive surgery, and
- •diagnosed with a vault prolapse.
排除标准
- •patients with prolapse and uterus in place,
- •those not requesting pelvic floor surgery,
- •patients who do not understand Swedish or are not capable to fulfill follow up procedure
结局指标
主要结局
anatomical failure (Failure was defined clinically as Ba, C or Bp at the hymen or below, on maximum Valsalva maneuver.)
时间窗: 1 year
The primary outcome measure was anatomical failure based on clinical assessment. Failure was defined clinically as Ba, C or Bp at the hymen or below, on maximum Valsalva maneuver.
次要结局
- prolapse symptoms(1 and 5 years)
- quality of life(1 and 5 years)
- continence status(1 and 5 years)
- sexual function(1 and 5 years)
研究者
Janusz Marcickiewicz
senior consultant
Sahlgrenska University Hospital, Sweden