Regular Diet After Colorectal Surgery

Weill Cornell Medicine (WCM)

Status: Not yet enrolling

Conditions: Post-operative Care; Surgery; Colorectal; Diet Habits

Treatments: Other: Historical Cohort: Low-Fiber Diet; Other: Regular Diet Post-Operatively

Study type: Interventional

Funder types: Other

Identifiers

NCT07540845

25-08029170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Regular Diet

Experimental group

Treatment:

Other: Regular Diet Post-Operatively

Historical Control

Other group

Description:

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

Treatment:

Other: Historical Cohort: Low-Fiber Diet