Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy: Study Protocol for Suture Plication Method: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- subjective symptom improvement
研究概览
简要总结
The anterior vaginal wall is the segment most commonly affected by prolapse. Traditionally, anterior vaginal wall prolapse is repaired via anterior colporrhaphy (native tissue repair), which is known to have a high recurrence rate. Several factors like the suture plication method might affect the outcome of anterior colporrhaphy. The use of single button sutures for example might be associated with the high recurrence rate because the sutures might not be able to retain adequate strength. Nonetheless, no comparative data exist so far regarding the efficacy and safety of anterior colporrhaphy when analyzing the plication method of sutures (= comparison between continuous stiches versus simple interrupted stiches).
The objective of this study is to compare the of patients undergoing anterior colporrhaphy due to symptomatic POP - using either continuous stiches or simple interrupted stiches.
This is a randomized, single-center, superiority trial. Anterior colporrhaphy will be performed in a traditional standardized manner in accordance with the policy of our institution. After midline incision and preparation of vesicovaginal fascia, midline plication of the fibromuscular layer is performed. Patients are randomized either to the group receiving continuous sutures or to the group with simple interrupted stitches. The primary outcome of interest is subjective symptom improvement (evaluated by German version of the pelvic floor questionnaire) assessed at 6 and 12 months after surgery. Secondary outcome variables include anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy. Due to the power calculation, an estimated and planned number of participants is 40.
详细描述
This trial is a single-center, prospective, randomized trial conducted with the aim of determining the superiority of continuous sutures over simple interrupted stitches with regard to the primary outcome in POP patients undergoing anterior colporrhaphy. The study will be a single-blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject is assigned. However, all outcome assessors and the subjects will be blinded to the treatment assignment. Postoperative follow-up will take place after 4-6 weeks, 6 months and 12 months. Patients will undergo a standardized urogynecological examination that includes assessment of prolapse with POP-Q measurement. Furthermore subjective outcome will be assessed with standardized questionnaires - our study participants will receive the German version of the pelvic floor questionnaire.
Study setting
This study will be conducted at the urogynecologic outpatient clinic (Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University of Vienna). Enrolment, treatment and data collection will be standardized by all sites according to the approved study protocol.
Participants and recruitment
The study population will consist of women aged 18 years or older who are referred to our urogynecologic outpatient clinic due to symptomatic POP. Women with anterior vaginal wall prolapse and an indication for reconstructive pelvic floor surgery - including anterior colporrhaphy with native tissue repair - can be included in this trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Anterior vaginal wall prolapse beyond the hymen (POPQ point Ba >0) with a central defect.
- •Vaginal bulge symptoms
- •Reconstructive surgery via native tissue repair is indicated and planned.
排除标准
- •Recurrent anterior vaginal wall prolapse
- •Anterior vaginal wall prolaps with lateral defect
- •Reconstructive surgery using mesh or obliterative surgery is planned
- •Known pelvic malignancy
- •Current systemic glucocorticoid or immunosuppressant treatment
- •Subject is unable or unwilling to participate
结局指标
主要结局
subjective symptom improvement
时间窗: 12 months
differences in the German version of the pelvic floor questionnaire (12 months after the operation compared to preoperative score, ranging from a minimum of 0 (better outcome) to a maximum of 2.875 (worse outcome))
次要结局
- anatomical outcomes(12 months)
- pain killers(30 days)
- operation time(1 day)
- blood loss(1 day)
- rate of adverse events(12 months)
研究者
Christine Bekos
Principan Investigator
Medical University of Vienna