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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
Sponsor:
Collaborator:
NU-Hospital Organization, Sweden
Information provided by (Responsible Party):
Mattias Prytz, Sahlgrenska University Hospital, Sweden

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.

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

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
Estimated Enrollment : 1450 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Short term mortality [ Time Frame: 30 days ]
    30 days overall mortality following acute laparotomy


Secondary Outcome Measures :
  1. Long term mortality [ Time Frame: 3 months ]
    3-months overall mortality following acute laparotomy

  2. Long term mortality [ Time Frame: 12 months ]
    12 months overall mortality following acute laparotomy

  3. Hospital stay [ Time Frame: 12 months ]
    Length of hospital stay for survivors following acute laparotomy

  4. Intesive care need [ Time Frame: 12 months ]
    The need for ICU-care following acute laparotomy

  5. Intesive care need [ Time Frame: 12 months ]
    The need for readmission to the ICU following acute laparotomy

  6. Surgical complications [ Time Frame: 12 months ]
    Surgical complications (according to the Clavien-Dindo score) following acute laparotomy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients at the department of surgery at NÄL, with the need for an acute laparotomy.
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)

Information from the National Library of Medicine

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


Contacts
Contact: Mattias Prytz, MD, PhD 010-435 35 23 ext +46 mattias.prytz@vgregion.se
Contact: Terje Timan Jansson, MD 010-435 14 38 ext +46 terje.jansson.timan@vgregion.se

Locations
Sweden
Department of Surgery, NU-Hospital/NÄL Recruiting
Trollhättan, Västra Götalandsregionen, Sweden, 46185
Contact: Mattias Prytz, MD, PhD    010-435 35 23 ext +46    mattias.prytz@vgregion.se   
Contact: Terje Timan Jansson, MD    010-435 14 38 ext +46    terje.jansson.timan@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
NU-Hospital Organization, Sweden
Investigators
Principal Investigator: Mattias Prytz, MD, PhD Sahlgrenska University Hospital an NU Hospital Oranization

Publications of Results:
Responsible Party: Mattias Prytz, MD, PhD. Head of Deperatment for Colorectal surgery, Department of Surgery, NU-Hospital Organization, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03549624     History of Changes
Other Study ID Numbers: Acute laparotomy NU
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Peritonitis
Abdomen, Acute
Intestinal Perforation
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Intestinal Diseases
Gastrointestinal Diseases