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

Active, not recruiting

• Conditions: Peritonitis; Ileus; Perforated Bowel; Acute Abdomen; Laparotomy
• Interventions: Other: Standardised protocol for the perioperative management in patients in need of an acute laparotomy

• Registration Number: NCT03549624
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-02-26
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1435

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention group	Standardised protocol for the perioperative management in patients in need of an acute laparotomy	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.

Primary Outcome Measures

Name	Time	Method
Short term mortality	30 days	30 days overall mortality following acute laparotomy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Surgery, NU-Hospital/NÄL; 🇸🇪 Trollhättan, Västra Götalandsregionen, Sweden