Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851794
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2023-05-01
Brief Title:
Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes in Large Sliding Hiatus Hernia With Severe Gastroesophageal Reflux Disease DeMeester Score 100 A Retrospective Comparative Study
Status:
COMPLETED
Status Verified Date:
2023-07
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:
Laparoscopic Nissen fundoplication LNF is a surgical intervention for gastroesophageal reflux disease GERD however it can be followed by recurrent symptoms or complications that may affect patient satisfaction Intraoperative endomanometric evaluation of esophagogastric competence and pressure combined with LNF in patients with large sliding hiatus hernia 5cm with severe GERD DeMeester score 100 is neededThis is a retrospective multicenter comparative study Baseline characteristics initial reflux symptoms preoperative and postoperative antacid medication use postoperative complications dysphagia and gas bloat syndrome recurrent symptoms and satisfaction were collected from a prospective database Outcomes measures were recurrent reflux symptoms postoperative side-effects and satisfaction with surgery Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables respectively
Detailed Description:
Laparoscopic Nissen fundoplication LNF is a surgical intervention for gastroesophageal reflux disease GERD however it can be followed by recurrent symptoms or complications that may affect patient satisfaction Intraoperative endomanometric evaluation of esophagogastric competence and pressure combined with LNF in patients with large sliding hiatus hernia 5cm with severe GERD DeMeester score 100 is needed
Study design This is a retrospective multicenter comparative study Baseline characteristics initial reflux symptoms preoperative and postoperative antacid medication use postoperative complications dysphagia and gas bloat syndrome recurrent symptoms and satisfaction were collected from a prospective database Outcomes measures were recurrent reflux symptoms postoperative side-effects and satisfaction with surgery Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables respectively
This study contributes to the mounting evidence for the effectiveness of endomanometric use during LNF Intraoperative HRM and Endoscope were feasible in all patients and demonstrated that the clinical outcomes for endomanometric NF were favorable from an effectiveness and safety standpoint
Study design This is a retrospective multicenter comparative study Baseline characteristics initial reflux symptoms preoperative and postoperative antacid medication use postoperative complications dysphagia and gas bloat syndrome recurrent symptoms and satisfaction were collected from a prospective database Outcomes measures were recurrent reflux symptoms postoperative side-effects and satisfaction with surgery Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables respectively
This study contributes to the mounting evidence for the effectiveness of endomanometric use during LNF Intraoperative HRM and Endoscope were feasible in all patients and demonstrated that the clinical outcomes for endomanometric NF were favorable from an effectiveness and safety standpoint
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