跳至主要内容
临床试验/CTRI/2021/10/037342
CTRI/2021/10/037342尚未招募不适用

Randomized study to compare the incidence of Surgical Site Infection in gunsight technique with conventional technique of stoma closure

NA1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
compare the rate of Surgical Site Infection between two groups, one receiving a gunsight skin incision and other conventional linear closure incision for stoma reversal.

研究概览

简要总结

Creation of the temporary intestinal stomas is an integral part of various emergency and elective surgical procedures1. Temporary diverting stoma such as loop ileostomy is commonly used in the colorectal cancer surgery, inflammatory bowel disease (ulcerative colitis) in order to reduce anastomotic complications2. Use of temporary stomas has been proven to be effective in cases of perforation peritonitis presenting with severe sepsis3, 4.

Stoma reversal (SR) is often considered by many surgeons to be a low morbidity operation. However, SR is associated with anastomotic leak, hernia formation, surgical site infections (SSIs), and nonsurgical complications, such as pneumonia, deep venous thrombosis, and urinary tract infection and a poor cosmetic outcome5,6. Surgical site infection is the most common complication associated with SR, and the reported incidence of SSI varies widely, from 2% to 40%7.

Various studies have evaluated several factors that may affect SSI rates following SR. In particular, different skin closure techniques have been studied with varying success in decreasing the rate of SSI8. Most studies report that primary closure (PC) is associated with the highest rate of SSI9. Several retrospective studies found that secondary closure (SC), delayed PC, and loose PC (LPC) are superior to primary closure10,11. Recently, various studies are being conducted on purse-string closure technique and it has been found effective in decreasing the rate of SSI as compared to other described techniques2, 11-13. Lim et al14 described the gunsight technique for stoma reversal and primary study suggested that the gunsight (GS) skin closure technique allows adequate surgical exposure, facilitates the creation of a small central hole, and provides a pleasant cosmetic scar. A multicenter, prospective, and randomized study was done by Han JG  and colleagues15 where they compared gunsight closure with the purse-string closure technique for SR and concluded that both the techniques are effective procedures, with a low incidence of wound infection but gunsight technique had the advantage of a shorter wound healing time and higher levels of patient satisfaction with regard to healing time. Another retrospective study on gunsight closure technique showed that GS technique can significantly decrease the rate of SSI when compared with the PC technique16. In this study we intent to compare the incidence of SSI in both the gunsight closure technique and the primary closure technique of stoma reversal.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Open Label

入排标准

年龄范围
14.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •1.All patients listed for elective stoma closure 2.Age ≥ 14 years 3.Giving informed consent.

排除标准

  • •1.Patients requiring laparotomy for stoma reversal 2.Patients having previous bogota closure scar mark 3.Patients having large para-stomal hernia requiring mesh repair 4.Co-existent psychiatric or neurological illness 5.Inability to answer the survey.

结局指标

主要结局

compare the rate of Surgical Site Infection between two groups, one receiving a gunsight skin incision and other conventional linear closure incision for stoma reversal.

时间窗: Post Operative day 3, day 5, day 7 and 3 months

次要结局

  • Secondary endpoint-(1.Time taken to complete healing)

研究者

发起方
NA
申办方类型
Other [not announced]

研究点 (1)

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