The New Transition Factors to Surgery of Duodenal Perforation

NCT06651008 | Completed

• 1 other identifier: Toho-retrospective study 1
• Study Type: observational
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Duodenum Ulcer Perforation

Keywords

conversion to surgery; conservative management,

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients of upper gastrointestinal perforation

You may not qualify if:

• DNR patients

Sponsors & Collaborators

• Toho University: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD, lecturer, head of upper gastrointestinal surgery group of toho ohashi hospital

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 21, 2024
• Study Start: January 1, 2012
• Primary Completion: July 30, 2023
• Study Completion: January 30, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: almost 1 year