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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03549624
Other study ID # Acute laparotomy NU
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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