NCT07540845

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Jan 2027

Study Start

First participant enrolled

April 1, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 14, 2026

Last Update Submit

April 21, 2026

Conditions

ColorectalDiet HabitsSurgeryPost-operative Care

Keywords

diet after surgerynutrition counseling

Outcome Measures

Primary Outcomes (2)

  • Number of 30-day readmissions

    30 Days post-operative

  • Surgery related morbidity

    30 Days Post-Operatively

Secondary Outcomes (3)

  • Percent of participants who complete the study (Feasibility)

    30 Days Post-Operatively

  • Number of participants who drop out of the study

    30 Days Post-Operatively

  • Number of participants removed from the study due to clinical determination

    30 Days Post-Operatively

Study Arms (2)

Regular Diet

EXPERIMENTAL
Other: Regular Diet Post-Operatively

Historical Control

OTHER

This comparator arm consists of information about the safety of patients treated in the past,

Other: Historical Cohort: Low-Fiber Diet

Interventions

Regular Diet Post-OperativelyOTHER

Participants will be advised to assume their regular diet post-operatively.

Regular Diet
Historical Cohort: Low-Fiber DietOTHER

Patients who were educated on and prescribed a low-fiber diet postoperatively.

Historical Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥ 18 years of age
  • Scheduled to undergo colorectal resection

You may not qualify if:

  • Patients with bowel obstructions
  • Patients below the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine-Section of Colon and Rectal Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Mehraneh Jafari, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KM Clinical Research Specialist

CONTACT

646-962-2789kmm4010@med.cornell.edu

Yasmeen Research Fellow

CONTACT

646-962-2789yub9013@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 20, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)