Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04879667
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2021-05-05
Brief Title:
Endoscopic Management Of Refractory Gastro-cutaneous Fistula After Laparoscopic Sleeve Gastrectomy l
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Endoscopic Management Of Refractory Gastro-cutaneous Fistula After Laparoscopic Sleeve Gastrectomy A Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 unexposedexposed 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
Detailed 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 unexposedexposed 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 iv 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 fistulaif the fistula had no track that was proved by CT with oral IV contrast we used the endoscopic stent if the fistula had track that was proved by CT with oral IV 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 iv 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 eg 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 Fishers Exact Test Continuous data were evaluated by student t- test The results were considered statistically significant when the significant probability was less than 005 P 005 P-value 0001 was considered highly statistically significant HS and P-value 005 was considered statistically insignificant NS
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 iv 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 fistulaif the fistula had no track that was proved by CT with oral IV contrast we used the endoscopic stent if the fistula had track that was proved by CT with oral IV 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 iv 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 eg 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 Fishers Exact Test Continuous data were evaluated by student t- test The results were considered statistically significant when the significant probability was less than 005 P 005 P-value 0001 was considered highly statistically significant HS and P-value 005 was considered statistically insignificant NS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None