Short Term Outcome Following Post Operative Enhanced Recovery Implementation in Patients With Perforated Peptic Ulcer

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.

Study Overview

• Status: Completed
• Conditions: Perforated Peptic Ulcer; Emergent Surgery
• Intervention / Treatment: Procedure: Post operative enhanced recovery elements

Detailed Description

This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcomes.

Methods: Quasi- experimental research design was utilized. The study was conducted at Assiut University Hospital.

A purposive sample of thirty patients (study group) who received postoperative enhanced recovery after open surgical repair of perforated peptic ulcer compared with thirty patients (control group) who exposed to routine care.

patient assessment sheet and gastrointestinal quality of life index were the tools used for data collection.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Faculty of Nursing

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ranged from 18 to 65 years,
• Diagnosed with perforated peptic ulcer,
• Ulcer size less than 10 mm.
• Underwent emergent surgical intervention

Exclusion Criteria:

• Malignant ulcer.
• Other GIT diseases (corn's disease & ulcerative colitis)
• Pregnant women
• Psychiatric or neurological illness.
• Who refused to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced recovery group; who received postoperative enhanced recovery after open surgical repair for perforated peptic ulcer	Procedure: Post operative enhanced recovery elements; 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.
No Intervention: Control group; who exposed to standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
gastrointestinal quality of life	gastrointestinal quality of life was evaluated for all patients before discharge and after thirty days postoperative using Gastrointestinal quality of life index (Eypasch, 1993). It is a 36-item scale divided into five domains; GIT symptoms (10 items), physical (6 items), emotion (6 items), social (2 items) and disease specific (8 items) Cronbach's alpha was 0.89 Scoring: Each item is based on a 0-4 Likert scale with 0 being least desirable to 4 being the most desirable option. The total scores represent Gastrointestinal Quality of Life Index. It ranges from 0 to 144 with higher scores indicating a better quality of life	Before hospital dicharge and after thirty days postoperative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Mahmoud Ayoub, Ass. prof., Assiut University -Assiut city

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Duodenal Diseases; Ulcer; Peptic Ulcer; Peptic Ulcer Perforation
• Other Study ID Numbers: Enhanced recovery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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