Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04879667 |
| Other study ID # |
Zagazig University Hospitalis |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2019 |
| Est. completion date |
April 1, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study included patients who were admitted to investigators' center to do laparoscopic
sleeve gastrectomy and complicated by gastro-cutaneous fistula . Cases were collected in the
period from December 2019 to march 2021. The study was approved by the research and Ethics
committee of investigators' University .a written informed consent was obtained from all
participating patients after explaining to them all the study procedures with its benefits
and hazards. the work has been carried out in accordance with the code of ethics of the world
medical association ( Declaration of Helsinki ) for studies involving humans .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 refractory gastro-cutaneous fistula by surgical intervention 50% and those with
successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated
sample size equal 30 patients divided into two equal groups. Group (1) included 15 patients
managed by surgical intervention , group (2) included 15 patients managed by endoscopic
intervention.
Description:
This study included patients who were admitted to investigators' center to do laparoscopic
sleeve gastrectomy and complicated by gastro-cutaneous fistula . Cases were collected in the
period from December 2019 to march 2021. The study was approved by the research and Ethics
committee of investigators' University .a written informed consent was obtained from all
participating patients after explaining to them all the study procedures with its benefits
and hazards. the work has been carried out in accordance with the code of ethics of the world
medical association ( Declaration of Helsinki ) for studies involving humans .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 refractory gastro-cutaneous fistula by surgical intervention 50% and those with
successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated
sample size equal 30 patients divided into two equal groups. Group (1) included 15 patients
managed by surgical intervention , group (2) included 15 patients managed by endoscopic
intervention.
Inclusion criteria:
Any patient complicated with gastrocutaneous fistula after laparoscopic sleeve gastrectomy.
patients with ASA I & II.
Exclusion criteria:
Any patient complicated with gastrocutaneous fistula after laparoscopic sleeve gastrectomy
and managed by conservative measures. Patients with bad general condition ASAIII.
Perioperative measures:
In this randomized control trials , 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 , ct with oral and i.v contrast to
assess if the fistula had track or not ) & patients were subjected to upper GI endoscopy to
assess the site , size & cause of fistula .
endoscopic techniques : we performed upper GI endoscopy to all cases first to assess the site
, size and cause of fistula . we used stents , clips , sutures and ballon dilatation to close
the fistula according to size , site and cause of fistula.if the fistula had no track that
was proved by CT with oral & I.V contrast , we used the endoscopic stent. if the fistula had
track that was proved by CT with oral & I.V contrast , we used the OVASCO clip , endo
suturing or ballon. Combined maneuvers may be used like ballon dilation and clipping or
ballon dilatation and suturing if there was distal narrowing.
Follow up after endoscopy and discharge from the hospital:
We examined the patients clinically, made routine laboratory investigations , made follow up
ct with oral and i.v contrast & patients were subjected to upper GI endoscopy. The patients
were followed up for one week, two weeks and one month, 6months post operatively.
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).
