Back to resultsA Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients
Primary Purpose
Gastroesophageal Reflux, Obesity
Status
Withdrawn
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
DPC
LSG
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux
Eligibility Criteria
Inclusion Criteria:
- Age between 18-65 years
- Patient with BMI between 35 and 50 Kg/m2 for whom laparoscopic sleeve gastrectomy indication was made
- Patients with no preoperative gastroesophageal reflux disease symptoms
- Hill 2-3 or 4 (with HH <2 cm) hypogastric valve diagnosed preoperatively
Exclusion Criteria:
- Gastroesophageal reflux disease with daily symptoms or daily use of proton pump inhibitors drugs or daily use of anti-H2 drugs
- Hiatal Hernia >2cm and/or esophagitis and/or Barrett metaplasia
- Previous bariatric and/or gastric surgery
- Normal gastroesophageal valve (Hill 1)
- Motility disorders of the esophagus (documented on manometry)
- PH-study positive for gastro-oesophageal reflux disease (DeMeester Score >14.1)
- Contraindications to gastroscopy or manometry or ph-study
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Patient not legally competent
- Pregnancy
Sites / Locations
- Ospedale Regionale di Lugano, Civico e Italiano
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LSG-DPC
LSG
Arm Description
Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure.
Laparoscopic Sleeve Gastrectomy
Outcomes
Primary Outcome Measures
De novo GastroEsophageal Reflux Disease (GERD) onset
At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GERD (GastroEsophageal Reflux Disease)
Secondary Outcome Measures
hiatal hernia appearance
At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect hiatal hernia appearance
change in patient-reported quality of life using Gastroparesis Cardinal Symptom Index (GCSI) questionnaire
Evaluation of benefits in term of life quality by Gastroparesis Cardinal Symptom Index (GCSI) self-assessment of gastroparesis symptoms.
The Gastroparesis Cardinal Symptom Index (GCSI), is a questionnaire that assess severity of symptoms associated with gastroparesis. Symptoms are rated from 0 (no symptom) to 5 (very severe)
change in patient-reported quality of life using GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) questionnaire
Evaluation of benefits in term of life quality and reduction of Protonic Pomp Inhibitors drugs by GERD-Health Related Quality of Life questionnaire.
Questionnaire (GERD-HRQL) for symptoms related to GERD. Symptoms are rated from 0 (no symptom) to 5 (Symptoms are incapacitating to do daily activities). The total Score is calculated by summing the individual scores to 15 questions.
Greatest possible score (worst symptoms) = 75
Lowest possible score (no symptoms) = 0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Evaluation of number of participants with treatment-related adverse events ( short and long term surgical complications)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04287972
Brief Title
A Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients
Official Title
A Monocentric Randomized Controlled Prospective Study to Evaluate the Antireflux Efficacy of Primary Crural Closure During Sleeve Gastrectomy for Obese Patients With Incompetents Oeso-gastric Valves
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Administrative issues
Study Start Date
November 8, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fabio Garofalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a monocentric randomized controlled prospective study. A total of 122 patients will be recruited and randomized 1: 1 in the experimental group - Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure - or in the control group - Laparoscopic Sleeve Gastrectomy.
At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GastroEsophageal Reflux Disease and hiatal hernia appearance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LSG-DPC
Arm Type
Experimental
Arm Description
Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure.
Arm Title
LSG
Arm Type
Active Comparator
Arm Description
Laparoscopic Sleeve Gastrectomy
Intervention Type
Procedure
Intervention Name(s)
DPC
Intervention Description
The anterior fat pad is dissected until the left crura is visible, pars flaccida is open and the right crura exposed. Phreno-oesophageal ligament is sectioned starting from the right crura. Posterior and anterior vagal nerve are recognized before the oesophageal dissection. An intra-abdominal oesophagus lengths of 2 or 3 cm is obtained in order to reduce tension. Left and right crura are sutured with 2 or 3 non absorbable 2-0 stitches; an additional anterior stitch is posed if necessary to calibrate hiatus size without oesophageal deviation.
Intervention Type
Procedure
Intervention Name(s)
LSG
Intervention Description
After omental section close to gastric insertion, gastric stapling is realised with triple line endo stapler (normally 5 or 6 re-loads). The gastrectomy begins 5-6 cm from the pylorus; gastric fundus is totally resected keeping a distance of 5-10 mm from oesophagus. Any bleeding on staple line is controlled with surgical clips or coagulator.
Primary Outcome Measure Information:
Title
De novo GastroEsophageal Reflux Disease (GERD) onset
Description
At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GERD (GastroEsophageal Reflux Disease)
Time Frame
6 months post surgery
Secondary Outcome Measure Information:
Title
hiatal hernia appearance
Description
At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect hiatal hernia appearance
Time Frame
6 months post surgery
Title
change in patient-reported quality of life using Gastroparesis Cardinal Symptom Index (GCSI) questionnaire
Description
Evaluation of benefits in term of life quality by Gastroparesis Cardinal Symptom Index (GCSI) self-assessment of gastroparesis symptoms.
The Gastroparesis Cardinal Symptom Index (GCSI), is a questionnaire that assess severity of symptoms associated with gastroparesis. Symptoms are rated from 0 (no symptom) to 5 (very severe)
Time Frame
baseline and 6 months post surgery
Title
change in patient-reported quality of life using GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) questionnaire
Description
Evaluation of benefits in term of life quality and reduction of Protonic Pomp Inhibitors drugs by GERD-Health Related Quality of Life questionnaire.
Questionnaire (GERD-HRQL) for symptoms related to GERD. Symptoms are rated from 0 (no symptom) to 5 (Symptoms are incapacitating to do daily activities). The total Score is calculated by summing the individual scores to 15 questions.
Greatest possible score (worst symptoms) = 75
Lowest possible score (no symptoms) = 0
Time Frame
baseline and 6 months post surgery
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Evaluation of number of participants with treatment-related adverse events ( short and long term surgical complications)
Time Frame
6 months post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18-65 years
Patient with BMI between 35 and 50 Kg/m2 for whom laparoscopic sleeve gastrectomy indication was made
Patients with no preoperative gastroesophageal reflux disease symptoms
Hill 2-3 or 4 (with HH <2 cm) hypogastric valve diagnosed preoperatively
Exclusion Criteria:
Gastroesophageal reflux disease with daily symptoms or daily use of proton pump inhibitors drugs or daily use of anti-H2 drugs
Hiatal Hernia >2cm and/or esophagitis and/or Barrett metaplasia
Previous bariatric and/or gastric surgery
Normal gastroesophageal valve (Hill 1)
Motility disorders of the esophagus (documented on manometry)
PH-study positive for gastro-oesophageal reflux disease (DeMeester Score >14.1)
Contraindications to gastroscopy or manometry or ph-study
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Patient not legally competent
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Garofalo
Organizational Affiliation
EOC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Regionale di Lugano, Civico e Italiano
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
A Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients
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