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

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 :(

Study Overview

• Status: Recruiting
• Conditions: Peptic Ulcer Perforation
• Intervention / Treatment: Other: Post operative early oral feeding; Other: Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohammed elshwadfy; Phone Number: 00201025524630; Email: m.elshwadfy1988@gmail.com
• Study Contact Backup: Name: ahmed elansary; Phone Number: 00201007267283; Email: ahmed_m_salah@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Recruiting
    • Cairo University
    • Contact: Ahmed Taha, Professor; Phone Number: +20 120 173 0249; Email: kasralainyrec@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; early oral intake 6 hours postoperative.	Other: Post operative early oral feeding; To start oral feeding 6 hours after perforated peptic ulcer repairs
Active Comparator: Group B; delayed oral intake after 72 hours	Other: Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs; To start oral feeding after 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of Post operative repair leak	number of Post operative repair leaks	30 days
severity of operative pain measured by Visual Analogue Scale (VAS)	from 1 to 10 1 indicated minimum pain and 10 maximum pain	7 days
INCIDENCE OF postoperative nausea and vomiting (PONAV)	number of cases with postoperative nausea and vomiting (PONAV)	7 days
incidence of Surgical site infection	number of cases complicated with surgical site infection	30 days
incidence of Pulmonary complications	number of cases complicated Pulmonary complications	30 days
incidence of Ryle reinsertion	number of cases complicated Ryle reinsertion	7 days
number of Readmission cases	number of cases complicated Readmission cases	30 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohammed ElShwadfy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Estimated): October 25, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Ulcer; Peptic Ulcer; Peptic Ulcer Perforation
• Other Study ID Numbers: N-96-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No