Efficacia Della Fibra di Psyllium Versus Placebo Nella Gestione Dell'Alvo in Pazienti Sottoposti ad Intervento Chirurgico Per Ostruita Defecazione
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- residual constipation
研究概览
简要总结
This study aims to assess whether fiber intake, formerly recommended only before or instead of surgery, may play a role in improving postoperative progress and functional outcome after STARR for obstructed defecation, in terms of residual constipation, incontinence and defecation urgency.
详细描述
After obtaining written informed consent and collecting baseline scores (T0), each patient was randomly assigned to one of the two groups and began taking sachets containing Psyllium fiber 3.5 g / day for Active group (A) and inert compound for Placebo group (P).
Sachet content was assigned by software randomization, written on a list and sealed in an envelope, which was opened only after the study was completed.
Post-operative instructions for both groups included only analgesic therapy (Ketorolac 10 to 30 mg b.m. if needed). Patients were also asked to stop any former laxative and to continue on a normal diet.
Each patient was re-evaluated at 7 ± 3 (T1), 60 ± 5 (T2) and 180 ± 15 (T3) days after surgery (Table 2).
A fluoroscopic colpocystodefecography (with patient sitting upright) was obtained before surgery and between 60-180 days postoperatively in order to assess comparability of the two groups and exclude negative organic outcomes that could affect functional results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age over 18
- •Diagnosis of Obstructed Defecation Syndrome according to ODS and CCS Score
- •STARR performed when ODS score >10
- •STARR performed 48-72 hours before
排除标准
- •Puborectalis or sphincter dyssynergia, evaluated by defecography and / or anorectal manometry
- •Concomitant diseases (fissure, abscess, fistula, IBD, diverticular disease)
- •Prolapse of other pelvic floor organs
- •Proctological surgery before STARR
- •Pregnancy or breast-feeding
- •Ongoing treatment with oral anticoagulants or steroid therapy
- •Conditions that do not allow patients to understand the nature and the purpose of the study
研究组 & 干预措施
Placebo
3.5 g /day of inert compound for 180 days after STARR
干预措施: Placebo (Drug)
Psyllium fiber
3.5 g /day of pure Psyllium fiber for 180 days after STARR
干预措施: Psyllium fiber (Drug)
结局指标
主要结局
residual constipation
时间窗: 180 days after STARR
ODS score and CCS score
次要结局
- Post-operative pain(180 days after STARR)
- revertence to laxative use(180 days after STARR)
- change in fecal incontinence from baseline(180 days after STARR)
- post-operative defecation urgency(180 days after STARR)
研究者
Francesco Gabrielli
professore ordinario di chirurgia generale
University of Milano Bicocca