Is Life Worth Living After Major Emergency GI Surgery? Patient Reported Outcome in Elderly Emergency Surgery Patients

NCT02377687 | Completed

• 1 other identifier: 2012-58-0004
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

To study the impact of emergency high risk GI surgery on HRQOL in elderly patients, seventy-five years or above and to explore the patients' experience with the informed consent process and the status 6 months after surgery.

Conditions

Emergency; Surgery

Keywords

Emergency surgery; HRQoL; Elderly

Outcome Measures

Primary Outcomes (1)

• HRQoL

  6 months after surgery

Secondary Outcomes (1)

• Functional status

  6 months after surgery

Study Arms (1)

elderly >75 years

all patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy

Other: observational study

Interventions

observational study OTHER

elderly >75 years

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will identify all patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy between the 1st of November 2014 and the 30st of April 2015. We will also include reoperations after elective surgery (major bleeding, anastomotic leakage etc.) and endoscopic procedures converted during the intervention (upper GI-bleeding, unsuccessful stenting of obstructing colorectal cancer etc.).

You may qualify if:

• patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy between the 1st of November 2014 and the 30st of April 2015. We will also include reoperations after elective surgery (major bleeding, anastomotic leakage etc.) and endoscopic procedures converted during the intervention (upper GI-bleeding, unsuccessful stenting of obstructing colorectal cancer etc.).

You may not qualify if:

• appendectomies, negative laparoscopy/laparotomy, laparoscopic cholecystectomy, acute hernias without strangulation, sub-acute internal hernia after Roux-en-Y gastric bypass surgery, sub-acute IBD-surgery and sub-acute Colorectal Cancer-surgery. Sub-acute is defined as planned in less than 48 hours.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Emergencies

Interventions

Observation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Morten Bay-Nielsen, DMSc

  Hvidovre University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 3, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)