External validation of surgical risk assessment tool(SORT) in predicting perioperative mortality in patients undergoing exploratory laparotomy surgery at an Indian tertiary care center and its possible feasibility in predicting postoperative morbidity.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity and independent t value of SORT as tool to look for its validation in Indian tertiary care center.
研究概览
简要总结
Single centre, Prospective, observational - longitudinal, Non-randomized. All the patients undergoing exploratory laparotomy participate in this study. This study will be conducted in Department of General Surgery, Department of Gastrointestinal surgery and Department of Surgical Oncology, Kasturba hospital, Manipal. The purpose of study is to externally validate- SORT(surgical outcome risk tool) in predicting post operative mortality in exploratory laparotomy based on following tool parameters – procedure code, operation severity, American Society of Anaesthesiologists’ physical status classification (ASA), clinical urgency, surgical site (thoracic, gastrointestinal or vascular surgery), cancer (active malignancy within the last 5 years) and age, all of which are available pre-operatively.
After patients have consented for this study, we will extract and included demographic data and clinical data.
We will also follow-up on, intra-op findings, postoperative clinicaland laboratory details during hospital stay on day-1, day-3, day-7, day 10 and day of discharge. If patient is discharged before 30 days post-op period, we’ll be following up via telephonic conversation on post-op 30th day regarding general condition of patient. We’ll define mortality as any patient death that occurring during the first 30 days or during the hospital stay if longer than 30 days. The predicted risk of mortality will be calculated using the SORT models.
And same scores will be used to check SORT’s very feasibility in predicting postoperative morbidity in patients undergoing same procedure.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •patients undergoing exploratory laparotomy in department of general surgery, Dept.
- •of GIS and Dept.
- •Surgical oncology.
- •Patients consenting to be part of study.
排除标准
- •Patients not willing to be part of study.
- •Patient lost to follow up.
结局指标
主要结局
Sensitivity, specificity and independent t value of SORT as tool to look for its validation in Indian tertiary care center.
时间窗: For each patient will be followed up on day- 1,3,7,10, 1month
次要结局
- Post-op morbidities will be looked for like- Surgical site infection, intra abdominal collection, paralytic ileus, enterocutenous fistula, atelectasis, urinary tract infection, abdominal wall dehiscience or incisional hernia(Each patient will be followed up on day-1,3,7,10,30th day to check on postoperative morbidity based on per abdominal findings, vital parameters like BP,pulse, spo02, drain tube collection, fluid input/output, ryles tube output.)
研究者
Dr Rohan Shashi Patil
KMC Manipal
