Real World Evaluation of the Effect of Gelsectan® in Low Anterior Resection Syndrome Patients: a Pilot Prospective Case-series Pilot Study (GeLAR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Low Anterior Resection Syndrome (LARS) score
研究概览
简要总结
Low Anterior Resection Syndrome (LARS) is an intestinal disorder affecting patients undergoing rectal resection for rectal cancer. A possible therapeutic option may be Gelsectan®, a class II device used in Irritable Bowel Syndrome (IBS). The aim of this study is to evaluate the efficacy of Gelsectan® in improving the symptoms of LARS.
详细描述
Low Anterior Resection Syndrome (LARS) affects almost 70% of patients after rectal resection for rectal cancer and is characterized by intestinal symptoms including urgency, fractioned defecation, and fecal incontinence. LARS is clinically diagnosed using the LARS score: a score higher than 21 indicates the presence of LARS and a score higher than 30 indicates severe LARS. The treatment opportunities for LARS are limited and failure rates are high. Gelsectan® is a class II device containing xyloglucans, xylo-oligosaccharides, pea proteins, and tannins from grape seeds extract, resulting effective in improving intestinal symptoms in patients with diarrheic Irritable Bowel Syndrome (IBS). Given the symptomatic similarities between LARS and IBS, Gelsectan® may represent a valid first line treatment for LARS patients.
The objective of this study is to provide preliminary data to determine whether the administration of Gelsectan® may ameliorate the symptoms of LARS.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than 18 years old.
- •Patients who underwent low rectal resection for rectal cancer and who closed the ileostomy at least three months before the screening visit.
- •Patients with a LARS score ≥21 and/or clinically relevant symptoms of urgency, increased stool frequency, or fecal incontinence.
- •Patients indicated to treatment with Gelsectan® according to the clinical judgment.
- •Oncological chemotherapy or radiotherapy completed at least four weeks before the screening visit.
- •Presence of a functional, intact anastomosis.
- •Female patients of childbearing potential must agree to use a reliable method of contraception.
排除标准
- •Known hypersensitivity to the investigational medicinal product (IMP).
- •Any condition that, in the opinion of the investigator, may interfere with the study procedures.
- •Significant anastomotic complications (e.g., strictures, fistula), which may impair the treatment efficacy.
- •Pregnant or breastfeeding women.
- •Inability to comply with the study procedures.
结局指标
主要结局
Low Anterior Resection Syndrome (LARS) score
时间窗: 28 days after treatment initiation
The median Low Anterior Resection Syndrome (LARS) score before and after the treatment with Gelsectan®. The Low Anterior Resection Syndrome (LARS) score ranges from 0 to 42, where 0 represent no LARS symtpoms and 42 represent major LARS symtpoms.
次要结局
- Stool incontinence(28 days after treatment initiation)
- Memorial Sloan Kettering Cancer Center Bowel Function Instrument (MSKCC-BFI) score(28 days after treatment initiation)
- Defecation fractioning(28 days after treatment initiation)
- Air incontinence(28 days after treatment initiation)
- Major Low Anterior Resection Syndrome (LARS) proportion(28 days after treatment initiation)
- Diarrhea(28 days after treatment initiation)
- Stool frequency(28 days after treatment initiation)
- Defecation urgency(28 days after treatment initiation)