A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Duomed
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Procedural efficacy - Number of participants with (serious) adverse events
研究概览
简要总结
The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Female patients.
- •Patient ≥ 18 years of age at study entry.
- •Patient and investigator signed and dated the informed consent form prior to the index-procedure.
- •Patient with primary rectal prolapse (grades I to V according to the Oxford scale), rectocele and/or enterocele.
排除标准
- •Patient is unable / unwilling to provide informed consent.
- •Patient with recurrent rectal prolapse, rectocele and/or enterocele.
- •Patient is unable to comply with the study protocol or proposed follow-up visits.
- •Patient has a contra-indication for laparoscopic ventral mesh rectopexy.
结局指标
主要结局
Procedural efficacy - Number of participants with (serious) adverse events
时间窗: Follow-up 4: 36 months after the procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Procedural efficacy - Number of re-interventions
时间窗: Follow-up 4: 36 months after the procedure
Number of re-interventions
Procedural efficacy - Conversion rate to laparotomy during the index procedure
时间窗: During procedure
Number of conversions to laparotomy during the index procedure
Procedural efficacy - Number of post-operative recurrences
时间窗: Follow-up 4: 36 months after the procedure
Number of post-operative recurrences
次要结局
- Functional score - Obstructive Defecation Syndrome (ODS) score(Follow-up 4: 36 months after the procedure)
- Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)(Follow-up 4: 36 months after the procedure)
- Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS)(At baseline)
- Functional score - Cleveland Clinical Incontinence Score (CCIS)(Follow-up 4: 36 months after the procedure)
- Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)(Follow-up 4: 36 months after the procedure)
- Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS)(At baseline)
- Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)(Follow-up 4: 36 months after the procedure)