Peptic Ulcer PerforationNCT06042933
Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair
A study testing Post operative early oral feeding and Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs in people with Peptic Ulcer Perforation, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate safety and benefits of early oral feeding compared to traditional delayed oral feeding in patients undergoing perforated peptic ulcer repairs. Study population \& Sample size :( Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Perforation
- What is being tested?
- Post operative early oral feeding and Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive patients, of age 18 years and above, who were
- presented to the emergency surgical team and were diagnosed with perforated duodenal ulcer by surgicalteam, were recruited and assessed for eligibility.
Who cannot join
- • Preoperative refractory septic shock on admission.
- Delayed presentation more than 24 hours.
- The presence of neuropsychiatric disease, pregnant and lactating women.
- Predisposing factors for impaired wound healing (e.g., currently using immunosuppressive agents, or chronic use of steroids), the presence of HIV.
- American society of anesthesiologists grade iii/iv, or had an alternative perioperative diagnosis.
- Intraoperatively, after randomization, patients were excluded based on the following criteria: perforated duodenal ulcer ≥20 mm, consistent with malignant ulcers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair: A Comparative Study in Egyptian Tertiary Health Care Center
This study aims to evaluate safety and benefits of early oral feeding compared to traditional delayed oral feeding in patients undergoing perforated peptic ulcer repairs. Study population \& Sample size :(
Read the detailed description
Study Design:
This study is a single-center, prospective, parallel arm, randomized controlled trial. Patients will be randomly assigned in 1:1 ratio to receive either delayed oral feeding or early oral feeding.
Methods:
Patients will be randomly assigned into two groups. Group A patients followed an early oral feeding protocol(12 hours), and Group B received delayed oral feeding (72 hours).
Outcome parameter :
The outcomes are incidence of postoperative complications including Postoperative repair leakage, Infection-related postoperative complications , Number of days of hospital stay and return of bowel function and Diet intolerance.
- Conditions
- Peptic Ulcer Perforation
- Being tested
- Post operative early oral feeding, Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs
- Medical subject headings
- Peptic Ulcer Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post operative early oral feedingOther
To start oral feeding 6 hours after perforated peptic ulcer repairs
Traditional delayed oral Feeding Post-perforated Peptic Ulcer RepairsOther
To start oral feeding after 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | early oral intake 6 hours postoperative. Receives: Other: Post operative early oral feeding |
| Group B | Active comparator | delayed oral intake after 72 hours Receives: Other: Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days of hospital stay
number of days of hospital stay
Measured: Up to 10 days
days needed for frist Bowel motion
number of days before frist bowel motion
Measured: 7 days
Secondary outcomes (7)
incidence of Post operative repair leak
number of Post operative repair leaks
Measured: 30 days
severity of operative pain measured by Visual Analogue Scale (VAS)
from 1 to 10 1 indicated minimum pain and 10 maximum pain
Measured: 7 days
INCIDENCE OF postoperative nausea and vomiting (PONAV)
number of cases with postoperative nausea and vomiting (PONAV)
Measured: 7 days
incidence of Surgical site infection
number of cases complicated with surgical site infection
Measured: 30 days
incidence of Pulmonary complications
number of cases complicated Pulmonary complications
Measured: 30 days
incidence of Ryle reinsertion
number of cases complicated Ryle reinsertion
Measured: 7 days
number of Readmission cases
number of cases complicated Readmission cases
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 Mar 2023
- Primary completion25 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer PerforationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Elshwadfy Nageeb, Cairo University
- Investigators
- mohammed elshwadfy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042933
- Sponsor's protocol ID
- N-96-2023
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair: A Comparative Study in Egyptian Tertiary Health Care Center
- ClinicalTrials.gov ID
- NCT06042933
- Acronym / sponsor ID
- N-96-2023
- Conditions
- Peptic Ulcer Perforation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 21 Sep 2023 (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.
This study aims to evaluate safety and benefits of early oral feeding compared to traditional delayed oral feeding in patients undergoing perforated peptic ulcer repairs. Study population \& Sample size :(
Detailed description
Study Design:
This study is a single-center, prospective, parallel arm, randomized controlled trial. Patients will be randomly assigned in 1:1 ratio to receive either delayed oral feeding or early oral feeding.
Methods:
Patients will be randomly assigned into two groups. Group A patients followed an early oral feeding protocol(12 hours), and Group B received delayed oral feeding (72 hours).
Outcome parameter :
The outcomes are incidence of postoperative complications including Postoperative repair leakage, Infection-related postoperative complications , Number of days of hospital stay and return of bowel function and Diet intolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Post operative early oral feedingearly oral intake 6 hours postoperative. |
| Group B | Active comparator | Other: Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairsdelayed oral intake after 72 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All consecutive patients, of age 18 years and above, who were
- presented to the emergency surgical team and were diagnosed with perforated duodenal ulcer by surgicalteam, were recruited and assessed for eligibility.
Key exclusion criteria (6 listed)
- • Preoperative refractory septic shock on admission.
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 |
|---|---|---|
| Post operative early oral feedingTo start oral feeding 6 hours after perforated peptic ulcer repairs | Other | Group A |
| Traditional delayed oral Feeding Post-perforated Peptic Ulcer RepairsTo start oral feeding after 48 hours | Other | Group B |
Primary outcome
number of days of hospital stay
Time frame: Up to 10 days
number of days of hospital stay
days needed for frist Bowel motion
Time frame: 7 days
number of days before frist bowel motion
7 secondary outcomes
incidence of Post operative repair leak
Time frame: 30 days
severity of operative pain measured by Visual Analogue Scale (VAS)
Time frame: 7 days
INCIDENCE OF postoperative nausea and vomiting (PONAV)
Time frame: 7 days
incidence of Surgical site infection
Time frame: 30 days
incidence of Pulmonary complications
Time frame: 30 days
incidence of Ryle reinsertion
Time frame: 7 days
number of Readmission cases
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
Related trials for Peptic Ulcer Perforation
Not yet recruiting
Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers
Perforated Peptic Ulcer, Peptic Ulcer Perforation
Not yet recruiting
Falciformopexy for Treatment Perforated Peptic Ulcer.
Perforated Peptic Ulcer
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. This study is not recruiting at the moment.
mohammed elshwadfy principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post operative early oral feeding and Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs in people with Peptic Ulcer Perforation, run by Cairo University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 29 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of days of hospital stay (time frame: Up to 10 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 29 Aug 2025.