Colorectal, Diet Habits, Post-operative Care, Surgery
Conditions
Keywords
diet after surgery, nutrition counseling
Brief summary
The goal of this pilot study is to assess the safety and feasibility of regular diet after surgical removal of the colon. The study will enroll patients preoperatively, prior to colon surgery, and will follow participants for up to 30 days. The study hypothesizes that simplifying nutritional recommendations is safe and may improve quality of life.
Detailed description
This pilot study aims to establish the safety of a return to a regular diet after surgery. Patients scheduled to undergo removal of a piece of their colon will be recruited before surgery and placed on a regular diet after surgery. Participants in this trial will be compared with previous patients who have undergone a similar surgery but were educated on and prescribed a low-fiber diet after surgery. Measures relating to morbidity and 30-day readmission rate will be collected prospectively. Surgical complications will also be collected. Participants will complete surveys about anxiety and quality of life at various time points in the study. The study will track the healthcare resources needed by participants during this study through a number of metrics, such as visits, phone calls, and messaging. The overarching goals of this study are to determine if resuming a regular diet after surgery is safe, if it impacts quality of life, and whether it increases how often patients need to engage with the healthcare system. The study will also explore associations with patient anxiety and strain on the care team in the form of communications related to diet.
Interventions
OTHERRegular Diet Post-Operatively
Participants will be advised to assume their regular diet post-operatively.
OTHERHistorical Cohort: Low-Fiber Diet
Patients who were educated on and prescribed a low-fiber diet postoperatively.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 years of age * Scheduled to undergo colorectal resection
Exclusion criteria
* Patients with bowel obstructions * Patients below the age of 18
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of 30-day readmissions | 30 Days post-operative |
| Surgery related morbidity | 30 Days Post-Operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants who complete the study (Feasibility) | 30 Days Post-Operatively | If more than \>70% subject complete the study, it will have been considered feasible. |
| Number of participants who drop out of the study | 30 Days Post-Operatively | Withdrawal by Post-Op Day 30 |
| Number of participants removed from the study due to clinical determination | 30 Days Post-Operatively | — |
Countries
United States
Contacts
CONTACTKM Clinical Research Specialist
CONTACTYasmeen Research Fellow
PRINCIPAL_INVESTIGATORMehraneh Jafari, MD
Weill Medical College of Cornell University
Outcome results
None listed