Back to resultsEarly Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair
Primary Purpose
Peptic Ulcer Perforation
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Post operative early oral feeding
Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs
Sponsored by
About this trial
This is an interventional treatment trial for Peptic Ulcer Perforation
Eligibility Criteria
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.
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
early oral intake 6 hours postoperative.
delayed oral intake after 72 hours
Outcomes
Primary Outcome Measures
number of days of hospital stay
number of days of hospital stay
days needed for frist Bowel motion
number of days before frist bowel motion
Secondary Outcome Measures
incidence of Post operative repair leak
number of Post operative repair leaks
severity of operative pain measured by Visual Analogue Scale (VAS)
from 1 to 10 1 indicated minimum pain and 10 maximum pain
INCIDENCE OF postoperative nausea and vomiting (PONAV)
number of cases with postoperative nausea and vomiting (PONAV)
incidence of Surgical site infection
number of cases complicated with surgical site infection
incidence of Pulmonary complications
number of cases complicated Pulmonary complications
incidence of Ryle reinsertion
number of cases complicated Ryle reinsertion
number of Readmission cases
number of cases complicated Readmission cases
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06042933
Brief Title
Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair
Official Title
Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair: A Comparative Study in Egyptian Tertiary Health Care Center
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
October 25, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 :(
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Perforation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
early oral intake 6 hours postoperative.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
delayed oral intake after 72 hours
Intervention Type
Other
Intervention Name(s)
Post operative early oral feeding
Intervention Description
To start oral feeding 6 hours after perforated peptic ulcer repairs
Intervention Type
Other
Intervention Name(s)
Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs
Intervention Description
To start oral feeding after 48 hours
Primary Outcome Measure Information:
Title
number of days of hospital stay
Description
number of days of hospital stay
Time Frame
Up to 10 days
Title
days needed for frist Bowel motion
Description
number of days before frist bowel motion
Time Frame
7 days
Secondary Outcome Measure Information:
Title
incidence of Post operative repair leak
Description
number of Post operative repair leaks
Time Frame
30 days
Title
severity of operative pain measured by Visual Analogue Scale (VAS)
Description
from 1 to 10 1 indicated minimum pain and 10 maximum pain
Time Frame
7 days
Title
INCIDENCE OF postoperative nausea and vomiting (PONAV)
Description
number of cases with postoperative nausea and vomiting (PONAV)
Time Frame
7 days
Title
incidence of Surgical site infection
Description
number of cases complicated with surgical site infection
Time Frame
30 days
Title
incidence of Pulmonary complications
Description
number of cases complicated Pulmonary complications
Time Frame
30 days
Title
incidence of Ryle reinsertion
Description
number of cases complicated Ryle reinsertion
Time Frame
7 days
Title
number of Readmission cases
Description
number of cases complicated Readmission cases
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed elshwadfy
Phone
00201025524630
Email
m.elshwadfy1988@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed elansary
Phone
00201007267283
Email
ahmed_m_salah@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammed elshwadfy
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Taha, Professor
Phone
+20 120 173 0249
Email
kasralainyrec@kasralainy.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair
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