The New Transition Factors to Surgery of Duodenal Perforation

The New Factors That Lead to Conversion Surgery in Patients with Duodenal Perforation When Initial Conservative Therapy is Not Completed

In this study,investigators sought to identify new transition factors in the initial evaluation of cases requiring conversion to surgery for duodenal ulcer perforation.

This was a retrospective study performed at investigators' hospital between January 2012 and July 2023 with upper gastrointestinal perforation. 27 patients, who underwent conservative management for the duodenal ulcer perforation, were extracted. Investigators researched the transition rate to surgery and the following factors: 1. Patient background, 2. Time from onset to hospital visit, 3. Vital signs and inflammatory findings on arrival, 4. CT findings of duodenal ulcer perforation and degree / shape of liver coverage for the perforation, and the extent of ascites.

Study Overview

• Status: Completed
• Conditions: Duodenum Ulcer Perforation

• Study Type: Observational
• Enrollment (Actual): 74

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

This was a retrospective study performed at our hospital between January 2012 and July 2023 with upper gastrointestinal perforation, and included 74 patients admitted to our hospital.

Description

Inclusion Criteria:

• patients of upper gastrointestinal perforation

Exclusion Criteria:

• DNR patients

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Conservative treatment completed group; The groupthat completed the conservative treatment for dudenum perforation.
Conversion to surgery group; The group that needed conversion to surgery for duodenum perforation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of conversion to surgery from conservative management for duodenal ulcer perforation.	Th investigators reasearched the transition rate to surgery based on the following factors: 1. Patient background, 2. Time from onset to hospital visit, 3. Vital signs and inflammatory findings on arrival, 4. CT findings of duodenal ulcer perforation and degree / shape of liver coverage for the perforation, and the extent of ascites.	nearly within 3days

Collaborators and Investigators

• Sponsor: Toho University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: conversion to surgery; conservative management,
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Duodenal Ulcer
• Other Study ID Numbers: Toho-retrospective study 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Imaging findings etc of study patients will be provided in an anonymous form.
• IPD Sharing Time Frame: almost 1 year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No