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

NCT03549624 | Unknown

• 1 other identifier: Acute laparotomy NU
• Study Type: observational
• Target: 1,435
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparotomy; Peritonitis; Ileus; Perforated Bowel; Acute Abdomen

Outcome Measures

Primary Outcomes (1)

• Short term mortality

  30 days overall mortality following acute laparotomy

  30 days

Secondary Outcomes (6)

• Long term mortality

  3 months

• Long term mortality

  12 months

• Hospital stay

  12 months

• Intesive care need

  12 months

• Intesive care need

  12 months

Study Arms (2)

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

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

Interventions

Standardised protocol for the perioperative management in patients in need of an acute laparotomy OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• All patients with the need of an acute laparotomy at NÄL

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• NU-Hospital Organization, Sweden: collaborator

Study Sites (1)

Department of Surgery, NU-Hospital/NÄL

Trollhättan, Västra Götalandsregionen, 46185, Sweden

Location

Related Publications (3)

• 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.

  PMID: 28112798 RESULT

• 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(1):57-66. doi: 10.1002/bjs.9658. Epub 2014 Nov 10.

  PMID: 25384994 RESULT

• Jansson 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.

  PMID: 34380437 DERIVED

MeSH Terms

Conditions

Peritonitis; Ileus; Intestinal Perforation; Abdomen, Acute

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Mattias Prytz, MD, PhD

  Sahlgrenska University Hospital an NU Hospital Oranization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Head of Deperatment for Colorectal surgery, Department of Surgery, NU-Hospital Organization

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: June 8, 2018
• Study Start: February 26, 2018
• Primary Completion: June 1, 2023
• Study Completion: September 6, 2023
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)