LaparotomySMASHNCT03549624
Standardized Perioperative Management of Patients Operated With Acute Abdominal Surgery in a High-risk Emergency Setting
An observational study of Laparotomy and Peritonitis, run by Sahlgrenska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparotomy, Peritonitis, Ileus
- What is being tested?
- Standardised protocol for the perioperative management in patients in need of an acute laparotomy
- How many people
- 1,435 participants
- Where
- 1 siteSweden
- Study dates
- 26 Feb 2018to 6 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients at the department of surgery at NÄL, with the need for an acute laparotomy.
Who may be able to join
- All patients with the need of an acute laparotomy at NÄL
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery, NU-Hospital/NÄL
Trollhättan, Västra Götalandsregionen, 46185
About this study
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.
Read the 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.
- Conditions
- Laparotomy, Peritonitis, Ileus, Perforated Bowel, Acute Abdomen
- Being tested
- Standardised protocol for the perioperative management in patients in need of an acute laparotomy
- Medical subject headings
- Peritonitis, Ileus, Intestinal Perforation, Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised protocol for the perioperative management in patients in need of an acute laparotomyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standardised protocol for the perioperative management in patients in need of an acute laparotomy | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Short term mortality
30 days overall mortality following acute laparotomy
Measured: 30 days
Secondary outcomes (6)
Long term mortality
3-months overall mortality following acute laparotomy
Measured: 3 months
Long term mortality
12 months overall mortality following acute laparotomy
Measured: 12 months
Hospital stay
Length of hospital stay for survivors following acute laparotomy
Measured: 12 months
Intesive care need
The need for ICU-care following acute laparotomy
Measured: 12 months
Intesive care need
The need for readmission to the ICU following acute laparotomy
Measured: 12 months
Surgical complications
Surgical complications (according to the Clavien-Dindo score) following acute laparotomy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start26 Feb 2018
- Primary completion1 Jun 2023 (estimated)
- Study completion6 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NU-Hospital Organization, Sweden
- Responsible party
- Principal investigator, Mattias Prytz, Sahlgrenska University Hospital
- Investigators
- Mattias Prytz, MD, PhD, Principal investigator, Sahlgrenska University Hospital an NU Hospital Oranization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549624
- Sponsor's protocol ID
- Acute laparotomy NU
- Acronym
- SMASH
- Status last verified
- Oct 2022
- First submitted
- 1 Mar 2018
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28112798Huddart 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.
PubMed 25384994Jansson 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.
PubMed 34380437
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Perioperative Management of Patients Operated With Acute Abdominal Surgery in a High-risk Emergency Setting
- ClinicalTrials.gov ID
- NCT03549624
- Acronym / sponsor ID
- SMASH / Acute laparotomy NU
- Conditions
- Laparotomy, Peritonitis, Ileus, Perforated Bowel, Acute Abdomen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,435 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- NU-Hospital Organization, Sweden
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 6 Sep 2023 (estimated)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: Standardised protocol for the perioperative management in patients in need of an acute laparotomyAll 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients at the department of surgery at NÄL, with the need for an acute laparotomy.
Key inclusion criteria (1 listed)
- All patients with the need of an acute laparotomy at NÄL
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardised protocol for the perioperative management in patients in need of an acute laparotomyA 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. | Other | Intervention group |
Primary outcome
Short term mortality
Time frame: 30 days
30 days overall mortality following acute laparotomy
6 secondary outcomes
Long term mortality
Time frame: 3 months
Long term mortality
Time frame: 12 months
Hospital stay
Time frame: 12 months
Intesive care need
Time frame: 12 months
Intesive care need
Time frame: 12 months
Surgical complications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Results publication: PubMed 28112798Tengberg 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.
- Results publication: PubMed 25384994Huddart 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.
- Derived from this study: PubMed 34380437Jansson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mattias Prytz, MD, PhD principal investigator
Sahlgrenska University Hospital an NU Hospital Oranization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparotomy and Peritonitis, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549624, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.