Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative)
研究概览
简要总结
Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.
One of the treatment options available is to repair the anterior wall surgically. The goals of surgery are to return the anatomy to its usual position, ensuring that all the pelvic floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair would also be long lasting.
Two surgical options are routinely performed in Calgary for repair of an anterior compartment prolapse. One option involves fixing the organs back in place using sutures. The other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The investigators do not know which of these two options is the best surgical procedure. Both may have different advantages that would result in better results. This study is designed to try and find out if one of these procedures is better, and if a larger study may be needed.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who require surgical correction for anterior compartment prolapse. (Concomitant surgery is permitted.)
- •Point Ba of 0 or greater: that is a positive Ba, indicating that the prolapse is beyond the introitus, not within the vagina.
- •Patient must consent to participate in the study.
排除标准
- •Having an obliterative procedure (Lefort procedure or colpocleisis).
- •Allergy to graft material.
- •Immunocompromised.
- •Previous anterior compartment repair.
- •Are unable to understand English.
- •Will be unavailable for follow-up.
研究组 & 干预措施
SIS Mesh (Cook Medical)
Anterior prolapse repair will be reinforced using SIS mesh
干预措施: SIS mesh (Cook Medical) (Device)
SIS Mesh (Cook Medical)
Anterior prolapse repair will be reinforced using SIS mesh
干预措施: Anterior prolapse repair (Procedure)
No-mesh
Anterior prolapse repair with no mesh reinforcement
干预措施: Anterior prolapse repair (Procedure)
结局指标
主要结局
Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative)
时间窗: 12 months postoperatively
次要结局
- Change in point Ba (on POP-Q) from baseline(12 months postoperatively)
- Pelvic Organ Prolapse Quantification(POP-Q) stage(12 months postoperatively)
- Change in POP-Q stage from baseline(12 months postoperatively)
- Postoperative complications(12 months postoperatively)
- Pelvic Floor Distress Inventory short form-20 (PFDI-20)(12 months postoperatively)
- Pelvic Floor Impact Questionnaire short form-7 (PFIQ-7)(12 months postoperatively)
- Sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)(12 months postoperatively)
- Surgical complications(Up to 6 weeks postoperatively)
- Satisfaction with surgical outcome(12 months postoperatively)
研究者
Dr. Sue Ross
Adjunct Professor
University of Calgary