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

October 31, 2022 updated by: Mattias Prytz, Sahlgrenska University Hospital, Sweden
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1435

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västra Götalandsregionen
      • Trollhättan, Västra Götalandsregionen, Sweden, 46185
        • Department of Surgery, NU-Hospital/NÄL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients at the department of surgery at NÄL, with the need for an acute laparotomy.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention group

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:

  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.
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.
Control group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term mortality
Time Frame: 30 days
30 days overall mortality following acute laparotomy
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term mortality
Time Frame: 3 months
3-months overall mortality following acute laparotomy
3 months
Long term mortality
Time Frame: 12 months
12 months overall mortality following acute laparotomy
12 months
Hospital stay
Time Frame: 12 months
Length of hospital stay for survivors following acute laparotomy
12 months
Intesive care need
Time Frame: 12 months
The need for ICU-care following acute laparotomy
12 months
Intesive care need
Time Frame: 12 months
The need for readmission to the ICU following acute laparotomy
12 months
Surgical complications
Time Frame: 12 months
Surgical complications (according to the Clavien-Dindo score) following acute laparotomy
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

NU-Hospital Organization, Sweden

Investigators

  • Principal Investigator: Mattias Prytz, MD, PhD, Sahlgrenska University Hospital an NU Hospital Oranization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2018

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 6, 2023

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acute laparotomy NU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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