Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05051683 |
| Other study ID # |
Zagazig General Surgery |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 30, 2019 |
| Est. completion date |
September 1, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
