Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Tata Memorial Hospital
This is a prospective, observational, non-interventional, non-randomized study involving the adult patients undergoing Whipple's procedure. Institutional ethics permission and written informed consent will be taken from the patient. The study duration will be for a period of 5 years, but the data of the first one year will be analysed and will presented as a thesis for MD (Anaesthesia). Administration of anaesthesia and reversal of neuromuscular blocking drugs will be carried as per the institutional routine practice and at the discretion of anaesthesiologist in charge. The study will include patients undergoing Whipple's procedure for pancreatic cancer, between age group of 18-75years, with ASA-PS I - III. Preoperative, intraoperative and outcome variables as defined according to the definitions established by the American college of surgeons National Surgeons Quality Improvement Program (NSQIP) will be recorded. A total of 11 preoperative, 14 intraoperative and 21 outcome variables will be collected (see Appendix). All the post operative outcome variables will be defined. Preoperative comorbid conditions will also be recorded. SAS will be calculated from three intraoperative variables (1) the estimated blood loss (EBL), (2) lowest heart rate (HR), and (3) lowest mean arterial pressure (MAP). For analysis, SAS will be classified as low (≤ 4 points), intermediate (5-6 points) and high (7-9 points). Complications including mortality will be assessed Upto 30 days postoperatively. The categorization of the complications as major and minor is consistent with NSQIP definition. Major complications include acute kidney injury, blood loss ≥ 2000ml, transfusion requiring ≥ 4 U packed blood cells within 72 hours of surgery, cardiac or respiratory arrest requiring cardiopulmonary resuscitation (CPR), coma for 24 hours or longer, deep venous thrombosis, septic shock, acute myocardial infarction, new onset arrhythmias, unplanned re-intubation, ventilator use for 48 hours or longer, pneumonia, pulmonary embolism, stroke, wound disruption, deep or organ space surgical site infection, sepsis, systemic inflammatory response syndrome, unplanned intensive care unit (ICU) admission, need for reoperation, anastomotic leak or fistula, vascular, ureteral or neural injuries, unplanned readmission \< 30 days of discharge, and death. The occurrence of major postoperative complications within 30 days of surgery represents primary outcome. Some of the patients do follow-up at day 30 to the OPD and those patients who don't follow-up at day 30 will be assessed and interviewed by telephone. If they are not able to follow-up on day 30, they will be contacted telephonically and interviewed for a period of 10-15 minutes, by a research nurse or a research doctor. Only mortality will be noted at day 30.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
