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

ConditionColorectal Anastomosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAyman Alayat

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a single, primary large bowel anastomosis

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • regular diet

    Behavioral

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

  • Clear fluids

    Behavioral

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Early regular feedingExperimental treatment 1 intervention
Group B: ConventionalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of post-operative ileus

Duration till the passage of flatus and stool will be documented

Time frame
from the beginning of the post-operative period up to 30 days
2

Rate of anastomotic leakage

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

Secondary outcomes

1

Length of hospital stay

Time frame
up to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ayman Alayat

Lead sponsor

Kasr El Aini Hospital

Sponsor institution

Source ClinicalTrials.gov
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