Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair

NCT06042933 | Completed DMC

• 1 other identifier: N-96-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 :(

Conditions

Peptic Ulcer Perforation

Outcome Measures

Primary Outcomes (2)

• number of days of hospital stay

  number of days of hospital stay

  Up to 10 days

• days needed for frist Bowel motion

  number of days before frist bowel motion

  7 days

Secondary Outcomes (7)

• incidence of Post operative repair leak

  30 days

• severity of operative pain measured by Visual Analogue Scale (VAS)

  7 days

• INCIDENCE OF postoperative nausea and vomiting (PONAV)

  7 days

• incidence of Surgical site infection

  30 days

• incidence of Pulmonary complications

  30 days

Study Arms (2)

Group A

EXPERIMENTAL

early oral intake 6 hours postoperative.

Other: Post operative early oral feeding

Group B

ACTIVE COMPARATOR

delayed oral intake after 72 hours

Other: Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs

Interventions

Post operative early oral feeding OTHER

To start oral feeding 6 hours after perforated peptic ulcer repairs

Group A

Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs OTHER

To start oral feeding after 48 hours

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Peptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• mohammed elshwadfy

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of general surgery

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: September 21, 2023
• Study Start: March 2, 2023
• Primary Completion: October 25, 2024
• Study Completion: November 1, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

EG (1)