Surgery Versus Laser Ablation of Anal Diseases in Inflammatory Bowel Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- pain score with visual analogue scale
研究概览
简要总结
This is a randomized comparative clinical trial carried out to compare between laser ablation and surgery in treating anal diseases in inflammatory bowel diseases patients and find out if one is superior to the other.
Inflammatory bowel diseases patients with anal problems were divided into 2 groups, one group had traditional surgery and the other had laser ablation for anal diseases and results were compared between the 2 groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with history of inflammatory bowel disease ( non specific colitis, crohn's disease, ulcerative colitis).
- •Patients who accidently discovered to have inflammatory bowel disease.
- •Age group between 18 to 60 years old
排除标准
- •Informed consent refusal.
- •Proved malignancy in inflammatory bowel disease patients
- •Patients less than 18 years old or more than 60 years old
- •Contraindications to general and spinal anesthesia
- •other types of colitis as ischemic colitis, pseudo-membranous colitis, infective colitis
结局指标
主要结局
pain score with visual analogue scale
时间窗: from the 1st day to 2 weeks postoperatively
pain score with visual analogue scale was studied between the 2 groups,minimum score is 0 which means painless and maximum score is 10 which means very painful
Healing time
时间窗: healing time was studies from the 1st day to 3 months after operation
time for complete healing after operation was studied between the 2 groups
Operation time
时间窗: Intraoperative (from skin incision to wound dressing.)
operation time in minutes was studied between the 2 groups
operative bleeding
时间窗: Intraoperative to 2 weeks after operation.
bleeding in cc was calculated between the 2 groups
post operative anal discharge
时间窗: from incision to 2 weeks after operation.
presence of post operative anal discharge was detected in the 2 groups
Return to work
时间窗: Return to work was assessed from one day to 2 months after surgery
Return to work after operation was studied between the 2 groups
patient satisfaction score
时间窗: from one day to 3 months after operation
patient satisfaction score among patients in the 2 groups was studied using customer satisfaction score, minimum score is 1 means very dissatisfied and maximum score is 10 means very satisfied
Fistula occurence
时间窗: from 2 weeks to 2 months after operation
fistula occurence studied between the 2 groups
Discharge from hospital
时间窗: from one day post operative to one week
hospital stay studied between the 2 groups
Recurrence
时间窗: detection of recurrence from 3 to 6 months after operation
recurrence between 2 groups was assessed
Stenosis
时间窗: stenosis was detected from wound healing to 6 months later
post operative stenosis between the 2 groups was studied
次要结局
- specific disease(diagnosis of diseases known 2 days before surgery from history)
- age(age of participants was recorded for one year duration of the study)
- sex(sex of participants was recorded for one year duration of the study)
研究者
Reham Zakaria Mohamed Ahmed
Principal Investigator
Zagazig University