Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

NCT04293653 | Completed

• 1 other identifier: REK7110
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

In the ProPEL study the effect of a protocol designed for elderly patients about to undergo emergency abdominal surgery will be investigated. The protocol addresses issues of both frailty and ceiling-of -care decisions.

Conditions

Frailty; Surgery--Complications; Outcome, Fatal; Frail Elderly Syndrome; Post-Op Complication; Gastro-Intestinal Disorder

Outcome Measures

Primary Outcomes (1)

• Composite score of 30-day mortality and postoperative complications

  Composite score will be calculated using the Comprehensive Complication Index ranging from 0 points (uneventful postoperative recovery) to 100 points (postoperative death). One investigator will review the patient's medical record postoperatively to investigate if any medical complication has occurred. Complications are defined according to the EPCO definitions and graded according to the Clavien-Dindo classification system.

  Up to 30 days after the performance of emergency abdominal surgery

Secondary Outcomes (11)

• Postoperative complications

  up to 90 days after date of emergency surgery

• Frequency of post-operative delirium

  up to 30 days after emergency surgery

• Length of stay in hospital after EAS

  up to 90 days after emergency surgery

• Patients' Level of independency as measured by the Barthel Activity of Daily Living Index before surgery and one year after surgery

  Patients will be assessed with the BArthel ADL-index when admitted to hospital and again one year after emergency abdominal surgery.

• Level of care at discharge from hospital and one year after EAS

  1 year after EAS.

Other Outcomes (1)

• 3-year survival

  Time (days) from end of index surgery and up to 3 years after EAS.

Study Arms (1)

Care bundle

EXPERIMENTAL

Patients above 75 years where emergency surgery is indicated, deemed fit for surgery, will be included in a perioperative care-bundle. While waiting for surgery, patients will be monitored and optimized if their condition deteriorates. Antibiotics will be administered if indicated. Surgery will be delivered within 2h to 72h, depending on the suspected abdominal pathology and the patient's clinical condition.

Other: Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy

Interventions

Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy OTHER

See above section

Care bundle

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• \- Patients above 75 years with clinical suspicion of abdominal condition requiring surgery

You may not qualify if:

• Surgery for incarcerated hernia without laparotomy
• Appendectomy without laparotomy
• Palliative surgery for already known inoperable gastrointestinal tumor
• Palliation without surgical treatment
• Vascular surgery

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Frailty; Postoperative Complications; Digestive System Diseases

Interventions

Clinical Protocols; Laparoscopy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ib Jammer, MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A care-bundle developed for patients above 75 years undergoing emergency abdominal surgery will be investigated, and the results will be compared to a group of historical controls operated at Haukeland University Hospital in 2016-2017, using 30-day mortality as the primary outcome.

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: March 3, 2020
• Study Start: January 21, 2020
• Primary Completion: June 30, 2021
• Study Completion: October 2, 2024
• Last Updated: October 4, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)