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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Emergency
• Intervention / Treatment: Other: observational study

Detailed Description

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.

The first part of the study will take place in the first postoperative week, while the patient is in hospital. After consent we will ask both patient and relatives/caregivers questions concerning the preoperative course and the informed consent. We will ask for permission to call the patients for a followup (the second part of the study) 5-7 months after discharge and permission to contact their closest relative. The closest relative is chosen by the patient and will after consent be asked the same questions in the first postoperative week and after 6 months.

The second part of the study will be initiated with a letter with SF-36 and an additional questionnaire . The SF-36 will be returned by letter. We will contact the patients by telephone 2 weeks after sending the letter ask them the questions from the additional questinaire.

We will compare the results from the SF-36 with age-matched controls (Data from the Danish SF-36 Manual).

If the patient is not capable of answering the questionnaires, the primary reason is noted (e.g. suffering from dementia or didn't speak Danish, dead).

We will aim at a 6 month follow-up period after discharge allowing a range from 5-7 months. Data acquisition will be done in the fall 2014 until late 2015.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.).

Description

Inclusion Criteria:

• 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.).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
elderly >75 years; all patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy	Other: observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HRQoL	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional status	6 months after surgery

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Study Chair: Morten Bay-Nielsen, DMSc, Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Elderly; Emergency surgery; HRQoL
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2012-58-0004 (Danish Data Protection Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO