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Recruiting NCT07540845

Regular Diet After Colorectal Surgery

No phase Interventional Colorectal Diet Habits Surgery Post-operative Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Regular Diet Post-Operatively, Historical Cohort: Low-Fiber Diet.
Who it may be relevant to
Registry conditions: Colorectal, Diet Habits, Surgery, Post-operative Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Regular Diet Post-Operatively
    Participants will be advised to assume their regular diet post-operatively.
  • Other Historical Cohort: Low-Fiber Diet
    Patients who were educated on and prescribed a low-fiber diet postoperatively.

Primary outcome measures

  • Number of 30-day readmissions [Time frame: 30 Days post-operative]
  • Surgery related morbidity [Time frame: 30 Days Post-Operatively]
Secondary outcome measures (3)
  • Percent of participants who complete the study (Feasibility) [Time frame: 30 Days Post-Operatively]
  • Number of participants who drop out of the study [Time frame: 30 Days Post-Operatively]
  • Number of participants removed from the study due to clinical determination [Time frame: 30 Days Post-Operatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Weill Cornell Medicine-Section of Colon and Rectal Surgery — New York

Identifiers

NCT: NCT07540845 · 25-08029170

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗