## Protocol Section
### Identification Module
**NCT ID:** NCT06421064

**Acronym:** PUD

**Brief Title:** Clinical Profile and Outcome of Perforated PUD

**Official Title:** Clinical Profile and Surgical Treatment Outcome of Perforated Peptic Ulcer Disease in Public Hospitals of Eastern Ethiopia: a Prospective Multicenter Study.

#### Organization Study ID Info
**ID:** HURG-2020
#### Organization
**Class:** OTHER
**Full Name:** Haramaya Unversity
### Status Module
#### Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2021-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Badhaasaa

#### Responsible Party

**Investigator Affiliation:** Haramaya Unversity

**Investigator Full Name:** Badhaasaa

**Investigator Title:** Assistant professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Perforated peptic ulcer disease (PPUD) is series illness that need emergency intervention. Its overall clinical profile and treatment outcome was also not well studied in developing countries. Therefore the study was aimed to see the outcome of surgical intervention and associated factors.

The study was a retrospective observational study conducted using the medical records of patients operated on for perforated peptic ulcer disease at a multicenter, in eastern Ethiopia.

**Detailed Description:** This study was designed to investigate the clinical characteristics and treatment outcomes among adult patients presented to the study areas. Three teaching Hospitals and one Regional Hospital were chosen and data collection was effected for two years. One hundred seventy patients participated in this observational study.

### Conditions Module

**Conditions:**

- Diseases or Conditions

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 170

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** All patients were operated with slight difference but all had perforation repaired.

**Name:** Perforation repair

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** This is a dichotomous variable, either survived or deceased.

**Measure:** Survival outcome of perforated PUD

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* All adults with a diagnosis of perforated PUD managed at HU until discharged

Exclusion Criteria:

* Patients who were referred to other institutions before official discharge, Incomplete Medical record

**Healthy Volunteers:** True

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All surgical emergency admissions.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Harar

**Country:** Ethiopia

**Facility:** Haramaya University

**Zip:** 251

### IPD Sharing Statement Module

**Description:** Owned by the university

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M13348

- Name: Peptic Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M13350

- Name: Peptic Ulcer Perforation

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
