NCT06570018

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

August 20, 2024

Last Update Submit

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

EXPERIMENTAL

who received postoperative enhanced recovery after open surgical repair for perforated peptic ulcer

Procedure: Post operative enhanced recovery elements

Control group

NO INTERVENTION

who 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.

Enhanced recovery group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Peptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • Mahmoud Ayoub, Ass. prof.

    Assiut University -Assiut city

    PRINCIPAL INVESTIGATOR

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

Locations