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

NCT07488013 | Recruiting

• 1 other identifier: MD-148-2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Anastomosis

Keywords

colorectal anastomosis; ERAS protocol; Early feeding

Outcome Measures

Primary Outcomes (2)

• Duration of post-operative ileus

  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

  from the beginning of the post-operative period up to 30 days

Secondary Outcomes (1)

• Length of hospital stay

  up to 4 weeks

Study Arms (2)

Early regular feeding

EXPERIMENTAL

Early regular feeding will be initiated within the first 12 hours post-operatively.

Behavioral: regular diet

Conventional

ACTIVE COMPARATOR

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

Interventions

regular diet BEHAVIORAL

Regular diet will be initiated within the first 12 hours post-operatively

Early regular feeding

Clear fluids BEHAVIORAL

Clear fluids will be initiated post-operatively and then gradually updated to regular diet as the patient regains his normal motions

Conventional

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a single, primary large bowel anastomosis

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ayman Alayat: lead

Study Sites (1)

Kasr Alainy

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Tarek Salem Mabrouk

CONTACT

00201143307034; tareksalem2018011@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 23, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

EG (1)