The Impact of Early Regular Diet vs Conventional Clear Fluids Regimen on Colorectal Anastomosis

March 17, 2026 updated by: Ayman Alayat

The goal of this clinical trial is to compare the effect of early regular feeding protocol vs conventional clear fluids regimen as per ERAS protocols in patients undergoing colorectal anastomosis. The main questions it aims to answer are:

  1. Food tolerance and return of normal bowel Habbits.
  2. Rate of Anastomotic leakage
  3. Length of hospital stay

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

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 Locations

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a single, primary large bowel anastomosis

Exclusion Criteria:

  • Patients with large bowel anastomosis and proximal diversion.
  • Patients with severe systemic illnesses or comorbidities that may impact surgical outcomes or dietary tolerance (e.g., severe heart failure, renal failure, liver failure).
  • Patients who require post-operative intensive care unit (ICU) admission or mechanical ventilation
  • Patients with pre-existing conditions that may affect gastrointestinal function or nutrient absorption (e.g., Crohn's disease, malabsorption syndromes).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early regular feeding
Early regular feeding will be initiated within the first 12 hours post-operatively.
Behavioral: regular diet
Regular diet will be initiated within the first 12 hours post-operatively
Active Comparator: Conventional
Clear fluids will be initiated within the first 12 hours post-operatively and then upgraded gradually as the patient regains normal bowel motions
Behavioral: Clear fluids
Clear fluids will be initiated post-operatively and then gradually updated to regular diet as the patient regains his normal motions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of post-operative ileus
Time Frame: from the beginning of the post-operative period up to 30 days
Duration till the passage of flatus and stool will be documented
from the beginning of the post-operative period up to 30 days
Rate of anastomotic leakage
Time Frame: from the beginning of the post-operative period up to 30 days
from the beginning of the post-operative period up to 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: up to 4 weeks
up to 4 weeks

Collaborators and Investigators

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

Sponsor

Ayman Alayat

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)

July 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-148-2025

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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