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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03749668
Other study ID # 2018-270
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2018
Est. completion date May 8, 2019

Study information

Verified date July 2019
Source University of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational study will quantify caloric-protein intake in 75 patients undergoing colorectal surgery within an enhanced recovery program at CHU Liège. A dietary survey will be performed preoperatively and repeated postoperatively via telephone calls on Day + 3, Day + 7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be correlated with the medical and surgical characteristics of the patients


Description:

For several years, we have been applying the concept of Enhanced Recovery Program (ERP) for colorectal surgery at CHU Liége (Belgium). Since October 2015, the University Hospital of Liège has been labelled as reference center for ERP after colorectal surgery by a French-speaking organization GRACE (French-speaking group for Enhanced Recovery after Surgery; www.grace-asso.fr). Despite the benefits for the patient and the economic benefits of such programs, some criticize ERP arguing that patients are asked to return home too early, while they have not recovered a satisfactory autonomy. Few studies have investigated the comfort and quality of home life of patients who have had ERP. We recently conducted a retrospective study to evaluate this quality of life. It turns out that patients report little postoperative pain, a sufficient degree of autonomy at home, and a high general satisfaction score (> 8.5 on a numerical scale of 0 to 10). However dietary and digestive difficulties were described by about one third of the patients questioned. [6] Others have also reported a caloric-protein deficit during the immediate postoperative period after colorectal surgery, up to the 7th day in some of their patients [7].

Aim of the study. The aim of this study is to assess caloric-protein intake up to one month after colorectal surgery within ERP.

General description. This observational study will quantify caloric-protein intake in 75 patients undergoing colorectal surgery according to an ERP at CHU Liège. A dietary survey will be performed preoperatively and repeated postoperatively via telephone calls on Day + 3, Day + 7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be correlated with the medical and surgical characteristics of the patients.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date May 8, 2019
Est. primary completion date May 8, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- any patient scheduled for colorectal surgery within an ERP at CHU Liège

Exclusion Criteria:

- unable to answer the survey (cognitive disorders, bad knowledge of the French language)

- closure of loop ileostomy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
non applicable
no intervention in this observational study

Locations

Country Name City State
Belgium University Hospital Liège

Sponsors (1)

Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary calorie and protein intakes Using a dietary survey postoperative intake of calories and protein will be assessed in patients scheduled for colorectal surgery one month after hospital discharge
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