NCT05051683: ppu

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

Completed NA Last updated 21 September 2021

What this trial tests

NA trial testing combined endoscopic & radiologic intervention for management of acute perforated peptic ulcer in Abdomen, Acute in 100 participants. Completed in 1 September 2021.

Timeline

30 December 2019

Primary endpoint
1 August 2021

1 September 2021

Quick facts

Lead sponsor	Zagazig University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	30 December 2019
Primary completion	1 August 2021
Estimated completion	1 September 2021
Sites	1 location across Egypt

Drugs / interventions tested

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

Conditions studied

• Abdomen, Acute — all drugs for Abdomen, Acute →

Sponsor

Zagazig University

Who can join

18 and older, any sex, with Abdomen, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Combined endoscopic and radiologic intervention for management of acute perforated peptic ulcer: a randomized controlled trial.
   Negm S, Mohamed H, Shafiq A, AbdelKader T, et al · · 2022 · cited 10× · PMID 35610657 · DOI 10.1186/s13017-022-00429-9
2. Combined Endoscopic & Radiologic Intervention For Management Of Acute Perforated Peptic Ulcer : A Randomized Controlled Trial
   Negm S, Mohamed H, Shafiq A, AbdelKader T, et al · · 2022 · DOI 10.21203/rs.3.rs-1304207/v1