Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial (PERECARE TRIAL)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- WEXNER INCONTINENCE SCORE
研究概览
简要总结
Study Purpose:
This study aims to understand how pelvic floor rehabilitation (PFR) after low anterior resection (LAR) surgery for rectal cancer affects bowel control and quality of life compared to usual care.
Background:
Rectal cancer and its treatments can significantly impact patients' lives, often causing bowel issues like frequent bowel movements, urgency, and incontinence. These problems, known as low anterior resection syndrome (LARS), affect 70-90% of patients and can last for over two years. (1,2)
Current Knowledge:
Advances in treatments have improved survival rates and recovery. Despite improvements, many patients still experience bowel issues after surgery.
Past studies show PFR can help, but they have limitations like small sample sizes and varied methods. (3-5)
Need for the Study:
There is a need for a well-designed study to confirm the benefits of PFR and to identify which patients benefit the most.
Study Design:
This study is a randomized controlled trial that will:
- Compare PFR to usual care in patients after LAR surgery.
- Focus on bowel control and quality of life.
- Provide detailed insights to improve aftercare for rectal cancer patients.
详细描述
This study will investigate the effects of pelvic floor rehabilitation (PFR) on bowel function and quality of life in patients who have undergone low anterior resection (LAR) for rectal cancer. The study aims to provide a more comprehensive understanding of effective aftercare for these patients. Here are the key components of the study protocol:
Study Design
Type: Randomized controlled trial.
Participants: Patients who have undergone LAR for rectal cancer.
Interventions: Pelvic floor rehabilitation compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Adults aged 18 years or older.
- •Surgical Procedure: Have undergone Low Anterior Resection (LAR) for rectal cancer.
- •Cognitive Ability: Capable of understanding and completing the questionnaires effectively
排除标准
- •Medical History: History of proctitis, ulcerative colitis, or Crohn's disease.
- •Surgical Extent: Extensive resection (beyond Total Mesorectal Excision - TME) for
- •locally advanced (T4) tumors, patients undergoing APR.
- •Surgical Complications: History of anastomotic leakage.
- •Recent Physiotherapy: History of invasive physiotherapy within the past 6 months.
- •Mental or Physical Inabilities: Inability to undergo Pelvic Floor Rehabilitation due to mental or physical limitations
研究组 & 干预措施
Pelvic Floor Physiotherapy (PFR) group
Patients completing three months post-low anterior resection (LAR) for rectal cancer or six weeks post-diversion ileostomy closure following LAR will be recruited to Pelvic Floor Rehabilitation (PFR) group after randomization.
Intervention: Participants will undergo a structured pelvic floor physiotherapy program for three months.
The program includes:
Eight Personal Sessions: Each session lasts 45 minutes.
Frequency:
- Once a week for the first month (four sessions).
- Biweekly for the next two months (four sessions).
Home Exercises: Participants will be guided on pelvic floor exercises to be performed at home throughout the three months.
Usual Care: In addition to the pelvic floor rehabilitation, participants will receive the standard postoperative care for rectal cancer surgery.
干预措施: Pelvic Floor Physiotherapy (PFR) (Behavioral)
Conventional group
Patients completing three months post-low anterior resection (LAR) for rectal cancer or six weeks post-diversion ileostomy closure following LAR will be recruited to Conventional group after randomization.
Recruited subjects in the conventional group recieves usual care following low anterior resection such as fluid intake, fiber intake, diet, toilet posture, life style advice etc
干预措施: Conventional group (Behavioral)
结局指标
主要结局
WEXNER INCONTINENCE SCORE
时间窗: Baseline score 6 weeks post-low anterior resection (LAR) or 6 weeks post-ileostomy closure. Post-intervention scores at 3 months post-start of pelvic floor physiotherapy for PFR group and 18 weeks post-LAR or post-ileostomy closure.
The Wexner Incontinence Score assesses fecal incontinence severity using patient-reported symptoms. Scores range from 0 (no incontinence) to 20 (severe incontinence), with higher scores indicating worse outcomes. Patients evaluate bowel control, leakage frequency, and lifestyle impacts, providing crucial data for treatment evaluation and comparison in clinical trials.
次要结局
- Quality of life measure QORTC CR 29(Baseline score 6 weeks post-low anterior resection (LAR) or post-ileostomy closure. Post-intervention scores at 3 months post-start of pelvic floor physiotherapy for PFR group and 6 months post-LAR or 18 weeks post-ileostomy closure.)
- Low Anterior Resection Syndrome score (LARS)(Baseline score 6 weeks post-low anterior resection (LAR) or 6 weeks post-ileostomy closure. Post-intervention scores at 3 months post-start of pelvic floor physiotherapy for PFR group and 18weeks post-LAR or 18 weeks post-ileostomy closure.)