COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Surgical Site infection
研究概览
简要总结
The study will be carried out in Surgical Unit-III, Lahore General Hospital, Lahore for one year . . Patients undergoing surgery for Ileostomy will be randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay.
详细描述
The study will be carried out in Surgical Unit-III, Lahore General Hospital. It will be a randomized control trial. Patients undergoing surgery for Ileostomy were randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow-up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay. The data will be statistically analyzed by using SPSS v23.0.t test (independent sample) used for the comparison of hospital stay mean. Chi-square will also used for the comparison of the frequencies of SSI. Data were stratified for gender and age. A p-value ≤0.05 will be considered as significant.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •included in the study
- •Patients of both gender
- •Patients ages between 25-70
- •Patients undergoing surgery for having ileostomy for benign disease of intestine (as per operational definitions).
排除标准
- •Following patients were excluded
- •Patients with pre-existing stomal site wound infection
- •Reversal of stoma through laparatomy
- •Post-operative anastomotic leak
- •Ureamic patients
- •Patients on chemotherapy and radiations
研究组 & 干预措施
Group B : conventional primary closure
allileostomies are reversed with conventional method
Group A: Purse string closure
the ileostomy reversal circular incision used with stitches of continuous and non-absorbable. The wound of skin was closed by using (Proline No. 1) that leaving 0.5 cm defect on middle in the skin.
干预措施: Purse string closure of Ileostomy (Procedure)
结局指标
主要结局
Surgical Site infection
时间窗: 14th post operative day
surgical site infection was graded according to southampton score grade IV and V
次要结局
未报告次要终点
研究者
Dr Anum Arif
Anum Arif
Combined Military Hospital, Pakistan