Clinical trial NCT03549624: Standardized Perioperative Management of Patients Operated With Acute Abdominal Surgery in a High-risk Emergency Setting
Official title: Standardized Perioperative Management of Patients Operated With Acute Abdominal Surgery in a High-risk Emergency Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laparotomy
Peritonitis
Ileus
Perforated Bowel
Acute Abdomen
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: NU-Hospital Organization, Sweden
First posted: 2018-06-08
Enrollment: 1435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients at the department of surgery at NÄL, with the need for an acute laparotomy.

Brief summary: The objective of the study is to handle patients with the need for an acute laparotomy according to a standardised perioperative protocol and to document the measurement as they are performed (i.e. adherence to the protocol) and to measure the outcome with regard to both short- (30 days) and long-term (3 and 12 months) mortality. Several secondary endpoints will be measured, such as: hospital stay, length of stay at an Intensive Care Unit (ICU), readmission to ICU and surgical complications according to the Clavien-Dindo score. These results will then be compared to published rates of mortality from the literature and to similar outcomes for a cohort of all patients operated at NÄL on the same indication the years prior to the project/study.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients with the need of an acute laparotomy at NÄL

Exclusion Criteria:

* Laparotomy planned in advance and without suspicion of an acute intraabdominal pathology.
* Abdominal wall hernias (with no suspicion of ileus or bowel ischemia)
* Appendectomy (Laparoskopically or open)
* Cholecystectomi (Laparoskopically or open)
* Acute thoracotomy
* Akute aortic surgery
* Planned second look-surgery (including change of open abdominal drapings/VAC)

Primary outcomes:
measure: Short term mortality
timeFrame: 30 days
Secondary outcomes:
measure: Long term mortality
timeFrame: 3 months
measure: Long term mortality
timeFrame: 12 months
measure: Hospital stay
timeFrame: 12 months
measure: Intesive care need
timeFrame: 12 months
measure: Intesive care need
timeFrame: 12 months
measure: Surgical complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Trollhättan
country: Sweden
facility: Department of Surgery, NU-Hospital/NÄL
state: Västra Götalandsregionen
Study officials:
affiliation: Sahlgrenska University Hospital an NU Hospital Oranization
name: Mattias Prytz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tengberg LT, Bay-Nielsen M, Bisgaard T, Cihoric M, Lauritsen ML, Foss NB; AHA study group. Multidisciplinary perioperative protocol in patients undergoing acute high-risk abdominal surgery. Br J Surg. 2017 Mar;104(4):463-471. doi: 10.1002/bjs.10427. Epub 2017 Jan 23.
citation: Huddart S, Peden CJ, Swart M, McCormick B, Dickinson M, Mohammed MA, Quiney N; ELPQuiC Collaborator Group; ELPQuiC Collaborator Group. Use of a pathway quality improvement care bundle to reduce mortality after emergency laparotomy. Br J Surg. 2015 Jan;102(1):57-66. doi: 10.1002/bjs.9658. Epub 2014 Nov 10.
citation: Jansson Timan T, Hagberg G, Sernert N, Karlsson O, Prytz M. Mortality following emergency laparotomy: a Swedish cohort study. BMC Surg. 2021 Aug 11;21(1):322. doi: 10.1186/s12893-021-01319-8.