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

Peritonitis Clinical Trial

— SMASH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03549624
• Other study ID #: Acute laparotomy NU
• Status: Active, not recruiting
• Start date: February 26, 2018
• Est. completion date: September 6, 2023

Study information

• Verified date: October 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1435
• Est. completion date: September 6, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Abdomen, Acute
• Acute Abdomen
• Emergencies
• Ileus
• Intestinal Perforation
• Laparotomy
• Perforated Bowel
• Peritonitis

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Surgery, NU-Hospital/NÄL	Trollhättan	Västra Götalandsregionen

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	NU-Hospital Organization, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term mortality	30 days overall mortality following acute laparotomy	30 days
Secondary	Long term mortality	3-months overall mortality following acute laparotomy	3 months
Secondary	Long term mortality	12 months overall mortality following acute laparotomy	12 months
Secondary	Hospital stay	Length of hospital stay for survivors following acute laparotomy	12 months
Secondary	Intesive care need	The need for ICU-care following acute laparotomy	12 months
Secondary	Intesive care need	The need for readmission to the ICU following acute laparotomy	12 months
Secondary	Surgical complications	Surgical complications (according to the Clavien-Dindo score) following acute laparotomy	12 months