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

Peptic Ulcer Perforation Clinical Trial

Official title:

Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair: A Comparative Study in Egyptian Tertiary Health Care Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042933
• Other study ID #: N-96-2023
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: mohammed elshwadfy
• Phone: 00201025524630
• Email: m.elshwadfy1988[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 :(

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 1, 2023
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Perforation
• Ulcer

Intervention

Other:
• Post operative early oral feeding
To start oral feeding 6 hours after perforated peptic ulcer repairs
• Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs
To start oral feeding after 48 hours

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of days of hospital stay	number of days of hospital stay	Up to 10 days
Primary	days needed for frist Bowel motion	number of days before frist bowel motion	7 days
Secondary	incidence of Post operative repair leak	number of Post operative repair leaks	30 days
Secondary	severity of operative pain measured by Visual Analogue Scale (VAS)	from 1 to 10 1 indicated minimum pain and 10 maximum pain	7 days
Secondary	INCIDENCE OF postoperative nausea and vomiting (PONAV)	number of cases with postoperative nausea and vomiting (PONAV)	7 days
Secondary	incidence of Surgical site infection	number of cases complicated with surgical site infection	30 days
Secondary	incidence of Pulmonary complications	number of cases complicated Pulmonary complications	30 days
Secondary	incidence of Ryle reinsertion	number of cases complicated Ryle reinsertion	7 days
Secondary	number of Readmission cases	number of cases complicated Readmission cases	30 days