- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07540845
Regular Diet After Colorectal Surgery
Impact of Postoperative Regular Diet on Colorectal Outcomes and Patient Quality of Life
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: KM Clinical Research Specialist
- Phone Number: 646-962-2789
- Email: kmm4010@med.cornell.edu
Study Contact Backup
- Name: Yasmeen Research Fellow
- Phone Number: 646-962-2789
- Email: yub9013@med.cornell.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- Weill Cornell Medicine-Section of Colon and Rectal Surgery
-
Contact:
- KM Muktasid
- Phone Number: 6469622270
- Email: kmm4010@med.cornell.edu
-
Contact:
- Yasmeen Chahal, MD
- Phone Number: 6469622270
-
Principal Investigator:
- Mehraneh Jafari, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Regular Diet
|
Participants will be advised to assume their regular diet post-operatively.
|
|
Other: Historical Control
This comparator arm consists of information about the safety of patients treated in the past,
|
Patients who were educated on and prescribed a low-fiber diet postoperatively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of 30-day readmissions
Time Frame: 30 Days post-operative
|
30 Days post-operative
|
|
Surgery related morbidity
Time Frame: 30 Days Post-Operatively
|
30 Days Post-Operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of participants who complete the study (Feasibility)
Time Frame: 30 Days Post-Operatively
|
If more than >70% subject complete the study, it will have been considered feasible.
|
30 Days Post-Operatively
|
|
Number of participants who drop out of the study
Time Frame: 30 Days Post-Operatively
|
Withdrawal by Post-Op Day 30
|
30 Days Post-Operatively
|
|
Number of participants removed from the study due to clinical determination
Time Frame: 30 Days Post-Operatively
|
30 Days Post-Operatively
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mehraneh Jafari, MD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-08029170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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