跳至主要内容
临床试验/CTRI/2024/05/066860
CTRI/2024/05/066860尚未招募2/3 期

Role of sodium hyaluronate and carboxy methylcellulose based bioresorbable membranes in decreasing intraabdominal adhesions

PGIMER1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
PGIMER
入组人数
22
试验地点
1
主要终点
To study the role of this bioresorbable membrane in reducing the severity of postoperative intraabdominal adhesions

研究概览

简要总结

Patient presenting to emergency or admitted in ward with any condition of intestines requiring a temporary stoma formation in which stoma reversal can be done in 6-8weeks post the stoma formation will be considered . In these patients a bioresorbable membrane would be placed beneath the stoma which will act as a barrier and reduce the formation of adhesions . Now during the stoma reversal surgery the adhesions formed would be noted and compared with the counterparts in which the membrane was not placed

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
12.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patient giving consent for the study who will undergo a temporary stoma formation in which stoma closure would be done in 6-8weeks.

排除标准

  • Permanent stoma formation.
  • Patient with prior history of abdominal TB and inflammatory bowel disease.
  • Patients in which stoma reversal is not possible in 6-8weeks.

结局指标

主要结局

To study the role of this bioresorbable membrane in reducing the severity of postoperative intraabdominal adhesions

时间窗: During 2nd surgery i.e 6-8 weeks post index surgery

次要结局

  • To study the decrease in operating time during surgery for stoma reversal(During 2nd surgery i.e 6-8weeks post index surgery)

研究者

发起方
PGIMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vinkle Panjoria

PGIMER , CHANDIGARH

研究点 (1)

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