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NCT Number: NCT06570018

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.

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Key information

Conditions

Emergent Surgery Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Peptic Ulcer Perforation Perforated Peptic Ulcer Stomach Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post operative enhanced recovery elements

Procedure

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.

Primary outcomes

  1. Gastrointestinal functional recovery (first bowel movement)

    Time frame: Within the first 24 hours postoperative or more

    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

  2. Gastrointestinal functional recovery(first flatus passage)

    Time frame: Within the first 24 hours postoperative or more

    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

  3. Gastrointestinal functional recovery(first stool passage)

    Time frame: First stool passage within three days postoperative or more

    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

  4. postoperative complications

    Time frame: Immediately post operative up to thirty days postoperative

    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

  5. Legnth of hospital stay

    Time frame: seven days up to two weeks

    Hospitalization duration from admission up to discharge Mean score of days for two groups will be compared.

Secondary outcomes

  1. gastrointestinal quality of life

    Time frame: Before hospital dicharge and after thirty days postoperative

    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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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