Anugel vs Gelatine Sponge Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Pain Reduction
研究概览
简要总结
Post-operational pain is the most common problem relating to haemorrhoidectomy. This study aims to evaluate the postoperative effects of Anugel a hydrogel impregnated multi component sponge vs gelatine sponge comparatively.
详细描述
The patients were placed in the lithotomy position. Haemorrhoids (piles) were later located through exploration. The piles were dissected using ligasure. After completing the dissection, bleeding was controlled and either Anugel or the gelatine sponge (SpongostanTM) is inserted in to the rectum as determined by patient allocation.
The patients were monitored post operation and 5 days following the surgery. Pain was measured using the VAS scale and use of pain medication was monitored.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Haemorrhoid (grade 3-4)
排除标准
- •Repeating cases, additional (non haemorrhoid related) complications
研究组 & 干预措施
Anugel
In this arm, after the surgery a hydrogel impregnated sponge will be placed in the rectum.
The patient is evaluated after the operation and the following day when the sponge is removed.
A hydrogel impregnated foam pad is applied on the surface of the wound the following 5 days.
The patient is evaluated on post op, on day 1 (usually before discharge) and day 5
The pain of the patients are evaluated according to the VAS scale and the use of analgesics and opioids is monitored.
干预措施: Anugel, Hydrogel sponge (Combination Product)
Sponge
Currently used treatment method i.e. insertion of gelatine sponge in to the rectum post operation.
The patient is evaluated on post op, on day 1 (usually before discharge) and day 5
The pain of the patients are evaluated according to the VAS scale and the use of analgesics and opioids is monitored.
干预措施: Gelatine Sponge (Combination Product)
结局指标
主要结局
Pain Reduction
时间窗: 5 days
Amount of pain patients feel post operation. Post surgery and on days 1 and 5 the pain felt by the patient will be measured according to the VAS scale, either in hospital or during hospital visit.
次要结局
- Use of analgesics(5 days)