Regular Diet After Colorectal Surgery

Impact of Postoperative Regular Diet on Colorectal Outcomes and Patient Quality of Life

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.

Study Overview

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

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine-Section of Colon and Rectal Surgery
        • Contact:
        • Contact:
          • Yasmeen Chahal, MD
          • Phone Number: 6469622270
        • Principal Investigator:
          • Mehraneh Jafari, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mehraneh Jafari, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-08029170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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