Standardised Perioperative Management of Patients Operated With Acute Abdominal Surgery (SMASH)
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|ClinicalTrials.gov Identifier: NCT03549624|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
|Condition or disease||Intervention/treatment|
|Laparotomy Peritonitis Ileus Perforated Bowel Acute Abdomen||Other: Standardised protocol for the perioperative management in patients in need of an acute laparotomy|
200-250 acute laparotomies are performed annually at NÄL. The operations are performed for a number of reasons, where operation due to ileus; with- or without bowel strangulation; operation for acute peritonitis due to different kinds of stomach- or bowel perforation and re-operations for complications to elective surgery are the most common. A common trait for all these patients is that they are all susceptible to negative effect on organ functions on virtually all organ systems due to the underlying condition/disease for which they are being operated. This impact on organ functions include negative effects on circulation (cardiovascular system), respiration, renal function, hepatic function, coagulation and central nervous system. Sepsis is common and causes/contributes to the impaired organ functions. Multi Organ Failure (MOF) is sometimes present both pre- and postoperatively. Hence these patients are critically ill, and the outcome with regard to morbidity is severe and mortality rates are high with numbers between 14% to 90% in different populations with different age and comorbidity.
Standard care for these patients in a Swedish setting is a rapid anesthesiological assessment of the patient, preoperative resuscitation - if deemed necessary - followed by surgical intervention. Postoperative care and monitoring dependent on local facilities/routines and individual assessment of the patient and the patients postoperative needs by the surgeon and anaesthetist together.
Recent studies from the United Kingdom indicate that at more standardised protocol with emphasis on six different measures have the possibility to improve postoperative outcome with regard to short term (30 days) mortality. The measures at hand are not new nor untried but the combination of measures including the shortened time to surgery are shown to be beneficial for the patients. The measures are: 1. early so called NEWS-monitoring (measuring of standard physiological parameters); 2. Early start of antibiotics; 3. Rapid (within 6 hours) start of operation; 4. Goal-directed fluid therapy; 5. Intensified post-operative monitoring; 6. The presence of both surgical and anesthesiological specialists in the early care of the patients.
This kind of standardised perioperative protocols has not yet been implemented in Swedish health-care.
|Study Type :||Observational|
|Estimated Enrollment :||1450 participants|
|Official Title:||Standardised Perioperative Management of Patients Operated With Acute Abdominal Surgery in a High-risk Emergency Setting|
|Actual Study Start Date :||February 26, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2022|
All adult (>18y) patients with the need of an acute laparotomy (within 6 hours) at NÄL.
Patients will be treated with an perioperative regime/protocol consisting of:
Other: Standardised protocol for the perioperative management in patients in need of an acute laparotomy
A standardised protocol for the perioperative management of patients including early start of antibiotics and swift surgical intervention as well as an emphasis on repeated monitoring of physiological parameters pre- and post-operatively.
All patients operated with an acute laparotomy at NÄL the years prior to the study will be retrospectively collected using the hospitals operation management database (Orbit©). Medical data will be collected from the patients' medical charts and outcome data (i.e. mortality, length of hospital stay, surgical complications, ICU-management etc.) will be registered
- Short term mortality [ Time Frame: 30 days ]30 days overall mortality following acute laparotomy
- Long term mortality [ Time Frame: 3 months ]3-months overall mortality following acute laparotomy
- Long term mortality [ Time Frame: 12 months ]12 months overall mortality following acute laparotomy
- Hospital stay [ Time Frame: 12 months ]Length of hospital stay for survivors following acute laparotomy
- Intesive care need [ Time Frame: 12 months ]The need for ICU-care following acute laparotomy
- Intesive care need [ Time Frame: 12 months ]The need for readmission to the ICU following acute laparotomy
- Surgical complications [ Time Frame: 12 months ]Surgical complications (according to the Clavien-Dindo score) following acute laparotomy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549624
|Contact: Mattias Prytz, MD, PhD||010-435 35 23 ext +firstname.lastname@example.org|
|Contact: Terje Timan Jansson, MD||010-435 14 38 ext +email@example.com|
|Department of Surgery, NU-Hospital/NÄL||Recruiting|
|Trollhättan, Västra Götalandsregionen, Sweden, 46185|
|Contact: Mattias Prytz, MD, PhD 010-435 35 23 ext +46 firstname.lastname@example.org|
|Contact: Terje Timan Jansson, MD 010-435 14 38 ext +46 email@example.com|
|Principal Investigator:||Mattias Prytz, MD, PhD||Sahlgrenska University Hospital an NU Hospital Oranization|