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Dietary Survey After Colorectal Surgery Within an Enhanced Recovery Program (DIETERP). (DIETERP)

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ClinicalTrials.gov Identifier: NCT03749668
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jean François Brichant, University of Liege

Study Description
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Brief 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

Condition or disease Intervention/treatment
Colorectal Surgery Calorie Deficiency Other: non applicable

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dietary Survey During the First Month After Colorectal Surgery Within an Enhanced Recovery Program
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : May 8, 2019
Actual Study Completion Date : May 8, 2019
Groups and Cohorts
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Intervention Details:
  • Other: non applicable
    no intervention in this observational study

Outcome Measures
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Primary Outcome Measures :
  1. calorie and protein intakes [ Time Frame: one month after hospital discharge ]
    Using a dietary survey postoperative intake of calories and protein will be assessed in patients scheduled for colorectal surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Any patient schedules for colorectal surgery with the ERP at CHU Liège (Belgium). Patients age must be greater than 18 years. There is no maximum limit of age.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749668


Locations
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Belgium
University Hospital
Liège, Belgium
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Jean-François Brichant, MD CHU Liege, Belgium
More Information
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Responsible Party: Jean François Brichant, Head of the Anesthesiology department, University of Liege
ClinicalTrials.gov Identifier: NCT03749668    
Other Study ID Numbers: 2018-270
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean François Brichant, University of Liege:
surgery: colorectal
enhanced recovery
caloric intake
protein intake