Combined Endoscopic & Radiologic Intervention For Management Of Acute Perforated Peptic Ulcer

NCT05051683 | Completed

• 1 other identifier: Zagazig General Surgery
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators included all patients who were developed acute perforated peptic ulcer manifestations and were admitted to our hospital between December 2019 to August 2021. The study was approved by the research and Ethics committee of our university and performed in accordance with the code of ethics of the world medical association (Declaration of Helsinki) for studies involving humans. A written informed consent was obtained from all participants. The sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , ratio of unexposed/exposed 1, percent of patients with successful management of acute perforated peptic ulcer by surgical intervention 90% and those with successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated sample size equal 100 patients divided into two equal groups. Group (1) included 50 patients managed by combined endoscopic \& radiologic intervention , group (2) included 50 patients managed by surgery.

Conditions

Abdomen, Acute

Keywords

perforated peptic ulcer

Outcome Measures

Primary Outcomes (1)

• incidence of complications after combined endoscopic & radiologic intervention

  incidence of complications after combined endoscopic \& radiologic intervention

  within one week after the endoscopy

Secondary Outcomes (1)

• incidence of mortality after combined endoscopic & radiologic intervention

  within one month after the endoscopy

Study Arms (2)

group (1)

ACTIVE COMPARATOR

combined endoscopic \& radiologic intervention for management of acute perforated peptic ulcer

Procedure: combined endoscopic & radiologic intervention for management of acute perforated peptic ulcer

group (2)

NO INTERVENTION

surgical management of acute perforated peptic ulcer

Interventions

combined endoscopic & radiologic intervention for management of acute perforated peptic ulcer PROCEDURE

endoscopic management using stent , clipping and sewing combined with radiologic interventional drainage was used. For duodenal ulcer only metallic stent was used due to narrow space while for gastric ulcer either stent , clipping and sewing were used due to capacious space.

group (1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patients with acute perforated peptic ulcer manifestations . \_ age over 18 years.

You may not qualify if:

• Patients presented with septic shock . \_ age below 18 years

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqua, 1185, Egypt

Location

Related Publications (1)

• Negm S, Mohamed H, Shafiq A, AbdelKader T, Ismail A, Yassin M, Mousa B, Abozaid M, Orban YA, Al Alawi M, Farag A. Combined endoscopic and radiologic intervention for management of acute perforated peptic ulcer: a randomized controlled trial. World J Emerg Surg. 2022 May 24;17(1):24. doi: 10.1186/s13017-022-00429-9.

  PMID: 35610657 DERIVED

MeSH Terms

Conditions

Abdomen, Acute; Peptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Said Mohamed Negm, MD

  ZAGAZIG UNIVERSITY HOSPITALS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of general surgery

Model Details: The investigators included all patients who were developed acute perforated peptic ulcer manifestations and were admitted to our hospital between December 2019 to August 2021. the calculated sample size equal 100 patients divided into two equal groups. Group (1) included 50 patients managed by combined endoscopic \& radiologic intervention , group (2) included 50 patients managed by surgery.

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: December 30, 2019
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)