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Standardized Perioperative Management of Patients Operated With Acute Abdominal Surgery in a High-risk Emergency Setting

Standardized Perioperative Management of Patients Operated With Acute Abdominal Surgery in a High-risk Emergency Setting

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03549624
Acronym
SMASH
Enrollment
1435
Registered
2018-06-08
Start date
2018-02-26
Completion date
2023-09-06
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Abdomen, Ileus, Laparotomy, Perforated Bowel, Peritonitis

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.

Interventions

OTHERStandardised 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.

Sponsors

NU-Hospital Organization, Sweden
CollaboratorOTHER
Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Short term mortality30 days30 days overall mortality following acute laparotomy

Secondary

MeasureTime frameDescription
Long term mortality3 months3-months overall mortality following acute laparotomy
Hospital stay12 monthsLength of hospital stay for survivors following acute laparotomy
Intesive care need12 monthsThe need for ICU-care following acute laparotomy
Surgical complications12 monthsSurgical complications (according to the Clavien-Dindo score) following acute laparotomy

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026