Colorectal AnastomosisNCT07488013
The Impact of Early Regular Diet vs Conventional Clear Fluids Regimen on Colorectal Anastomosis
A study testing regular diet and Clear fluids in people with Colorectal Anastomosis, run by Ayman Alayat at 1 site in Egypt.
Trial 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. Food tolerance and return of normal bowel Habbits. 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Colorectal Anastomosis
- What is being tested?
- regular diet and Clear fluids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a single, primary large bowel anastomosis
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy
Cairo
Tarek Salem Mabrouk, 00201143307034, tareksalem2018011@gmail.com
About this study
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:
- Food tolerance and return of normal bowel Habbits.
- Rate of Anastomotic leakage
- Length of hospital stay
- Conditions
- Colorectal Anastomosis
- Being tested
- regular diet, Clear fluids
- Keywords
- colorectal anastomosis, ERAS protocol, Early feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular dietBehavioural
Regular diet will be initiated within the first 12 hours post-operatively
Clear fluidsBehavioural
Clear fluids will be initiated post-operatively and then gradually updated to regular diet as the patient regains his normal motions
| Study group | Role | What they receive |
|---|---|---|
| Early regular feeding | Experimental | Early regular feeding will be initiated within the first 12 hours post-operatively. Receives: 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 Receives: Behavioral: Clear fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of post-operative ileus
Duration till the passage of flatus and stool will be documented
Measured: from the beginning of the post-operative period up to 30 days
Rate of anastomotic leakage
Measured: from the beginning of the post-operative period up to 30 days
Secondary outcomes (1)
Length of hospital stay
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Jul 2025
- Primary completion31 Aug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AnastomosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayman Alayat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayman Alayat, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488013
- Sponsor's protocol ID
- MD-148-2025
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Regular Diet vs Conventional Clear Fluids Regimen on Colorectal Anastomosis
- ClinicalTrials.gov ID
- NCT07488013
- Acronym / sponsor ID
- MD-148-2025
- Conditions
- Colorectal Anastomosis
- Keywords
- colorectal anastomosis, ERAS protocol, Early feeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ayman AlayatUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Food tolerance and return of normal bowel Habbits.
- Rate of Anastomotic leakage
- Length of hospital stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early regular feeding | Experimental | Behavioral: regular dietEarly regular feeding will be initiated within the first 12 hours post-operatively. |
| Conventional | Active comparator | Behavioral: Clear fluidsClear fluids will be initiated within the first 12 hours post-operatively and then upgraded gradually as the patient regains normal bowel motions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with a single, primary large bowel anastomosis
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regular dietRegular diet will be initiated within the first 12 hours post-operatively | Behavioural | Early regular feeding |
| Clear fluidsClear fluids will be initiated post-operatively and then gradually updated to regular diet as the patient regains his normal motions | Behavioural | Conventional |
Primary outcome
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
Rate of anastomotic leakage
Time frame: from the beginning of the post-operative period up to 30 days
1 secondary outcome
Length of hospital stay
Time frame: up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regular diet and Clear fluids in people with Colorectal Anastomosis, run by Ayman Alayat at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarek Salem Mabrouk (00201143307034, tareksalem2018011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of post-operative ileus (time frame: from the beginning of the post-operative period up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.