Ignite Creation Date:
2024-05-06 @ 2:49 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04433507
Status:
TERMINATED
Last Update Posted:
2022-12-02
First Post:
2019-06-07
Brief Title:
Antireflux Efficacy of Hiatal Hernia Repairs in Sleeve Gastrectomy Patients
Sponsor:
Hopital du Sacre-Coeur de Montreal
Organization:
Hopital du Sacre-Coeur de Montreal
Study Overview
Official Title:
Antireflux Efficacy of Hiatal Hernia Repairs Concomitant to Sleeve Gastrectomy in Obese Patients BMI 35-50
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastroesophageal reflux GR occurrence or persistence following a sleeve gastrectomy SG can be correlated to several factors but it is clear that one of the key factors is a persistent hiatal hernia or laxity of the esophageal hiatus However there are no clear guidelines presently available on surgical management of small size hernias or an abnormal hiatus Therefore hiatal hernia management is decided intraoperatively by the operating surgeon The main goal of this study is to evaluate the efficacy of primary hiatal hernia repairs on gastroesophageal reflux concomitant to sleeve gastrectomy The secondary objectives are hiatal hernia recurrence following primary surgery and the occurrence of de novo GR
Detailed Description:
Background
The Sleeve gastrectomy SG is the most common bariatric procedure worldwide because it is the simplest to perform from a technical standpoint and the most efficient in terms of metabolic control and weight loss However this intervention can lead to several complications including the onset or intensification of gastroesophageal reflux GR with the associated impact on the patients quality of life and a possible evolution into Barretts esophagus One of the key factors in the development of this complication is a persistent hiatal hernia
Aims The main objective of this study is to provide an objective evaluation of the effect of primary hiatal hernia repair on GR concomitant to sleeve gastrectomy The secondary objectives are hiatal hernia recurrence following primary surgery and the occurrence of de novo GR
Methods
A total of 100 patients will be recruited for the pilot study with 50 patients in the SG group and 50 in the SG primary hiatal hernia repair group following randomization Then based on a sample size study recruitment will be continued as needed None of the procedures performed are experimental All obese patients with a BMI between 35-50 aged 18-65 and undergoing surgery for a SG in the institutions bariatric surgery department will be eligible to participate in this study Exclusion criteria will be hiatal hernias greater than 2 cm a hiatal repair requiring a drain prior bariatric surgery or any other counterindication to SG All patients will be evaluated preoperatively using 1 EGD 2 esophageal manometric study 3 pH assessment and 4 validated GR questionnaires GERD-HRPL GCSI Iconographic intraoperative data on hiatal morphology and the type of cure used will be collected and records will be kept according to Ethics committee guidelines After a 6-month follow-up the participants will undergo the same tests including questionnaires for a medium-term profile
The Sleeve gastrectomy SG is the most common bariatric procedure worldwide because it is the simplest to perform from a technical standpoint and the most efficient in terms of metabolic control and weight loss However this intervention can lead to several complications including the onset or intensification of gastroesophageal reflux GR with the associated impact on the patients quality of life and a possible evolution into Barretts esophagus One of the key factors in the development of this complication is a persistent hiatal hernia
Aims The main objective of this study is to provide an objective evaluation of the effect of primary hiatal hernia repair on GR concomitant to sleeve gastrectomy The secondary objectives are hiatal hernia recurrence following primary surgery and the occurrence of de novo GR
Methods
A total of 100 patients will be recruited for the pilot study with 50 patients in the SG group and 50 in the SG primary hiatal hernia repair group following randomization Then based on a sample size study recruitment will be continued as needed None of the procedures performed are experimental All obese patients with a BMI between 35-50 aged 18-65 and undergoing surgery for a SG in the institutions bariatric surgery department will be eligible to participate in this study Exclusion criteria will be hiatal hernias greater than 2 cm a hiatal repair requiring a drain prior bariatric surgery or any other counterindication to SG All patients will be evaluated preoperatively using 1 EGD 2 esophageal manometric study 3 pH assessment and 4 validated GR questionnaires GERD-HRPL GCSI Iconographic intraoperative data on hiatal morphology and the type of cure used will be collected and records will be kept according to Ethics committee guidelines After a 6-month follow-up the participants will undergo the same tests including questionnaires for a medium-term profile
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