Short Term Outcome Following Post Operative Enhanced Recovery Implementation in Patients With Perforated Peptic Ulcer
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcome. The current study anticipated better outcomes in the form of early functional recovery, reduced length of hospital stays, less thirty days post operative morbidity, and better gastrointestinal quality of life after implementing post operative enhanced recovery in patients with perforated peptic ulcer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2024
CompletedFirst Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 26, 2024
CompletedJanuary 29, 2025
January 1, 2025
10 months
August 20, 2024
January 27, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Gastrointestinal functional recovery (first bowel movement)
Tool; Patient assessment sheet * It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first bowel movement) through physical examination. * The mean score of time for two groups was compared
Within the first 24 hours postoperative or more
Gastrointestinal functional recovery(first flatus passage)
Tool; Patient assessment sheet * It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first flatus passage) through physical examination. the mean score of time for two groups was compared
Within the first 24 hours postoperative or more
Gastrointestinal functional recovery(first stool passage)
Tool; Patient assessment sheet \- It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first stool passage) postoperative.through health history. The mean score of time for two groups was compared
First stool passage within three days postoperative or more
postoperative complications
post operative complications included complications that occured within 30- days post operative. Every patient had been assessed for developing pneumonia, admission to critical care, abdominal collection, intra-abdominal abscess, suture leakage, omental patch leakage, septic shock, prolonged ileus, surgical site infection, urinary tract infection, deep venous thrombosis (DVT), and reoperation
Immediately post operative up to thirty days postoperative
Legnth of hospital stay
Hospitalization duration from admission up to discharge Mean score of days for two groups will be compared.
seven days up to two weeks
Secondary Outcomes (1)
gastrointestinal quality of life
Before hospital dicharge and after thirty days postoperative
Study Arms (2)
Enhanced recovery group
EXPERIMENTALwho received postoperative enhanced recovery after open surgical repair for perforated peptic ulcer
Control group
NO INTERVENTIONwho exposed to standard care
Interventions
According to the study group the researchers collaborated with surgeons, nurses, and anesthesiologists to implement post operative enhanced recovery protocol that defined clearly in the following elements Early nutrition, Early mobilization, Non-opioid analgesia. Early removal of abdominal drains and tubes throughout the patients' hospital stay up to their discharge.
Eligibility Criteria
You may qualify if:
- Age ranged from 18 to 65 years,
- Diagnosed with perforated peptic ulcer,
- Ulcer size less than 10 mm.
- Underwent emergent surgical intervention
You may not qualify if:
- Malignant ulcer.
- Other GIT diseases (corn's disease \& ulcerative colitis)
- Pregnant women
- Psychiatric or neurological illness.
- Who refused to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Nursing
Asyut, 71111, Egypt
Related Publications (1)
Desoky AA, Ayoub MT, Mostafa NM, Hashem EM, Mohammed MA. Short-term outcome following postoperative enhanced recovery implementation in patients with perforated peptic ulcer. Eur J Med Res. 2025 Apr 4;30(1):234. doi: 10.1186/s40001-025-02432-7.
PMID: 40186297DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud Ayoub, Ass. prof.
Assiut University -Assiut city
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant professor of Medical Surgical Nursing
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 26, 2024
Study Start
October 1, 2023
Primary Completion
July 15, 2024
Study Completion
August 15, 2024
Last Updated
January 29, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share