- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05051683
Combined Endoscopic & Radiologic Intervention For Management Of Acute Perforated Peptic Ulcer (ppu)
Combined Endoscopic & Radiologic Intervention For Management Of Acute Perforated Peptic Ulcer : A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed 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. Any patients with acute perforated peptic ulcer manifestations and age over 18 years were included. Patients presented with septic shock and age below 18 years were excluded.
Perioperative measures:
In this prospective randomized controlled trial , all patients were subjected to the followings: patients were selected by randomization method , Full history taking , Complete physical examination , laboratory investigations ( complete blood picture , liver and kidney functions , coagulation profile ) , radiological investigations ( chest x- ray erect , abdominal & pelvic u/s ).
Surgical techniques :
Traditional surgical exploration and Graham omental patch repair with abdominal lavage either open or laparoscopy was done for group (2). For group (1) 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.
Metallic stent:
Upper GI endoscopy ( Model GIF - 2TH180; Olympus , Tokyo, Japan) was done , allowing through it stent placement. The endoscopy was passed beyond the site of perforation , a guide wire was passed through the endoscopy into the proximal part of the jejunum and a partially covered duodenal stent ( Hanaro, MI-tech Korea) was advanced and released over the wire ( Jagwire ; Boston Scientific , Marlborough , M , USA) to cover the perforation site. Attention was taken to place the oral part of the stent above the pylorus and the covered part of the stent at site of perforation.
At same time of stent placement a radiologic interventional team worked and drainage was done & 2 intra-peritoneal tube drains were inserted one was placed sub-hepatic another was placed in the pelvis.
During postoperative day one a methylene blue test was done . and blue color was observed in the drain.
Stent was removed 3 weeks later and site of perforation was observed . if there was any sings of remaining perforation a new stent was placed for another 3 weeks.
Endoscopic clips:
Clips are used to approximate the tissue surrounding the defect to effect closure. Standard clips should be deployed perpendicular to the long axis of the defect. If needed, multiple clips can be placed sequentially, starting at either edge of a defect and meeting at the center. Currently available through-the-scope clips achieve superficial tissue apposition engaging the mucosa and submucosa (with 1.2-mm-wide and 6-mm-long arms capable of an approximately 12-mm grasp), and have been used in conjunction with thermal ablation or mechanical scraping of the tissue around the edges of the defect to achieve a more resilient seal. The Over-the-Scope Clip (Ovesco Endoscopic AG, Tubingen, Germany) is a nitinol clip placed on a cap at the endoscope tip . Unlike clips inserted through the endoscope, the OVESCO can perform full-thickness apposition.
At same time a radiologic interventional team worked and drainage was done & 2 intra-peritoneal tube drains were inserted one was placed sub-hepatic another was placed in the pelvis.
During postoperative day one a methylene blue test was done . and blue color was observed in the drain.
Sewing:
The Stomaphy X suturing system (Endo Gastric Solutions, Redmond, WA) and the Apollo Over Stitch (Apollo Endo surgery, Austin, TX), which creates full-thickness plications , has shown early success .
At same time a radiologic interventional team worked and drainage was done & 2 intra-peritoneal tube drains were inserted one was placed sub-hepatic another was placed in the pelvis.
During postoperative day one a methylene blue test was done . and blue color was observed in the drain.
Follow up after surgery and discharge from the hospital:
The investigators examined the patients clinically, made routine laboratory investigations , and for group (1) upper GI endoscopy at 2 weeks later.
Statistical analysis:
The collected data were analyzed by computer using Statistical Package of Social Services version 22 (SPSS), Data were represented in tables and graphs, Continuous Quantitative variables e.g. age were expressed as the mean ± SD & (range), and categorical qualitative variables were expressed as absolute frequencies (number) & relative frequencies (percentage).
Suitable statistical tests of significance were used after checked for normality. Categorical data were cross tabulated and analyzed by the Chi-square test or Fisher's Exact Test; Continuous data were evaluated by student t- test. The results were considered statistically significant when the significant probability was less than 0.05 (P < 0.05). P-value < 0.001 was considered highly statistically significant (HS), and P-value ≥ 0.05 was considered statistically insignificant (NS).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sharqua
-
Zagazig, Sharqua, Egypt, 1185
- Zagazig University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any patients with acute perforated peptic ulcer manifestations . _ age over 18 years.
Exclusion Criteria:
- Patients presented with septic shock . _ age below 18 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group (1)
combined endoscopic & radiologic intervention for management of acute perforated peptic ulcer
|
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.
|
No Intervention: group (2)
surgical management of acute perforated peptic ulcer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of complications after combined endoscopic & radiologic intervention
Time Frame: within one week after the endoscopy
|
incidence of complications after combined endoscopic & radiologic intervention
|
within one week after the endoscopy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of mortality after combined endoscopic & radiologic intervention
Time Frame: within one month after the endoscopy
|
incidence of mortality after combined endoscopic & radiologic intervention
|
within one month after the endoscopy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Said Mohamed Negm, MD, Zagazig University Hospitals
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Zagazig General Surgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdomen, Acute
-
Assiut UniversityCompletedNon Enhanced MSCT Abdomen in Diagnosis of Acute AbdomenEgypt
-
Amal Fathy Abo ElgaradUnknown
-
Assiut UniversityUnknownUltra Sound in Diagnosis of Acute Abdomen in Pediatric Group
-
Assiut UniversityUnknownPatient Presented With Acute Abdomen | Patient Undergoing Urgent GIT Surgery
-
Pitié-Salpêtrière HospitalAssociation pour la Recherche et la Formation en Anesthésie Analgésie RéanimationCompleted
-
Zealand University HospitalWithdrawnAcute AbdomenDenmark
-
Azienda Ospedaliero-Universitaria di ModenaCompleted
-
Michigan State UniversityCompleted
-
Kuopio University HospitalCompleted
-
Karolinska InstitutetRegion StockholmCompleted