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Postoperative Care clinical trials

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NCT ID: NCT01799369 Completed - Postoperative Care Clinical Trials

Surgical Apgar Score in Clinical Practice: a Pilot Study

SAS
Start date: April 2011
Phase: N/A
Study type: Interventional

Background Surgeons lack a routine, objective evaluation of patient condition after surgery. We currently rely on subjective assessment of available patient data. The current scoring methods such as Acute Physiology and Chronic Health Evaluation and Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity are complex and cumbersome and have therefore not been adopted into routine practice. The Surgical Apgar Score (SAS) is a simple score on a scale of 0 to 10 calculated from 3 parameters collected during the operation: lowest heart rate, lowest blood pressure, estimated blood loss (Regenbogen et al., Arch Surg 2009). Previous validation studies have shown a good correlation between the score and incidence of major complications or death occurring within 30 days. For example, 75% patients with a score of 0-2 had major complications, whereas it was only 5% in those with a score of 9-10. To date, the SAS has never been clinically applied and tested in a trial. We believe that routine use of the SAS will lead to a reduction in major complications and deaths after surgery. We also believe that it will lead to a reduction in the severity of the complications. This is based on our theory that the SAS eliminates the guesswork. Using this score will add objectivity and clarity to clinical decisions that are presently based on clinical instinct or 'gut feeling'. The score will more clearly highlight those patients who are at an increased risk of developing complications or dying and will flag them up for increased monitoring, a higher index of clinical suspicion and a lower threshold for early management of problems. Primary Aim The primary aim of the pilot is to strengthen the design and assess the feasibility of the main study on the SAS. We aim to recruit 100 patients in each group, 200 in total. The primary aim of the main study will be to establish if clinical application of the SAS leads to a reduction in 30-day post-operative morbidity and mortality. Study Design The design of this pilot is the same as what the main trial will eventually be: a multicentre single-blind randomised controlled trial (RCT). Current data suggests the overall expected major complication or death rate in our target population would be 21%. The sample size of the future RCT is therefore estimated to be 986 each group to detect a 5% reduction in complications (Significance 0.05%, Power 80%). Outcomes Our primary outcome will be major complications or death within 30 days of operation. Our secondary outcomes (all within 30 days of operation) will be minor complications, primary and secondary critical care admissions and length of stay, duration of therapeutic antibiotics, number of additional operations under general anaesthetic to treat complications, and overall length of stay.

NCT ID: NCT01549353 Completed - Postoperative Care Clinical Trials

Gum Chewing After Gynecologic Laparoscopy

Start date: July 2011
Phase: N/A
Study type: Interventional

Gum chewing has been reported to stimulate bowel motility after open surgery, such as cesarean section and other abdominal surgeries. In general, after laparoscopic surgery problems with reduced bowel motility are not as common as after open surgery. In this study the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel motility after gynecologic laparoscopic surgery. Further the investigators study patient satisfaction and potential side effects of postoperative gum chewing.

NCT ID: NCT01191528 Completed - Postoperative Care Clinical Trials

The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index (IPI)

Start date: August 2010
Phase: N/A
Study type: Observational

To compare two ways to test breathing after surgery in acute care setting. One method tests oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is breathed out.

NCT ID: NCT01084070 Completed - Postoperative Care Clinical Trials

Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Start date: March 2010
Phase: Phase 3
Study type: Interventional

The traditional postoperative care after abdominal surgery included the need of nasogastric tube, fasting until resumed bowel function and progressive reinstitution of oral intake from liquid to solid diet. Recent studies have shown no benefits of this traditional management over early oral feeding. Nevertheless, the researches in emergency surgery are scarce.

NCT ID: NCT00938210 Completed - Fatigue Clinical Trials

Rehabilitation Following Laparoscopic Colonic Surgery

Start date: May 2009
Phase: N/A
Study type: Interventional

The standard procedure for treating colonic cancer is changing from open surgery to laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass and have a reduction in physical function, but the investigators do not know if this is also the case following laparoscopic surgery. This study examines how fatigue, quality of life, physical function, and body composition changes following laparoscopic colonic surgery. Patients are examined preoperatively and postoperative day 10 and 30.

NCT ID: NCT00134407 Completed - Postoperative Care Clinical Trials

Postoperative Oral Intake Trial

Start date: February 2001
Phase: Phase 1
Study type: Interventional

Complete fasting until resumed bowel function after upper abdominal surgery is not beneficial. Enteral feeding has been claimed to be the preferred way of delivering nutritional support postoperatively. Increasing evidence suggests that letting patients eat ("voluntary oral feeding" or "oral intake at will") from the day after the operation is safe. No prospective randomised trial has been undertaken to compare these two regimens. In this study, the investigators will randomise 444 patients, subject to major upper abdominal surgery, into receiving either continuous enteral feeding by needle catheter jejunostomy until resumed bowel function, or to oral intake at will from postoperative day 1. The main endpoints are the incidence rate of major complications and death, as well as a Quality of Life assessment. Null-Hypothesis: Routine postoperative feeding by needle catheter jejunostomy after major, upper abdominal surgery has no clinically relevant advantages over early oral intake at will.