Gastroesophageal RefluxNCT04287972
A Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients
A study testing DPC and LSG in people with Gastroesophageal Reflux and Obesity, run by Fabio Garofalo at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux, Obesity
- What is being tested?
- DPC and LSG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Nov 2019to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale di Lugano, Civico e Italiano
Lugano, 6900
About this study
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
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.
- Conditions
- Gastroesophageal Reflux, Obesity
- Being tested
- DPC, LSG
- Medical subject headings
- Gastroesophageal Reflux, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPCProcedure or surgery
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.
LSGProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| LSG-DPC | Experimental | Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure. Receives: Procedure: DPC; Procedure: LSG |
| LSG | Active comparator | Laparoscopic Sleeve Gastrectomy Receives: Procedure: LSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months post surgery
Secondary outcomes (4)
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
Measured: 6 months post surgery
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)
Measured: baseline and 6 months post surgery
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
Measured: baseline and 6 months post surgery
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)
Measured: 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start8 Nov 2019
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Why it stopped: Administrative issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabio Garofalo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabio Garofalo, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Fabio Garofalo, Principal investigator, EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287972
- Sponsor's protocol ID
- ORL-CHIR-003
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04287972
- Acronym / sponsor ID
- ORL-CHIR-003
- Conditions
- Gastroesophageal Reflux, Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fabio GarofaloUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSG-DPC | Experimental | Procedure: DPC, Procedure: LSGLaparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure. |
| LSG | Active comparator | Procedure: LSGLaparoscopic Sleeve Gastrectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPCThe 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. | Procedure or surgery | LSG-DPC |
| LSGAfter 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. | Procedure or surgery | LSG, LSG-DPC |
Primary outcome
De novo GastroEsophageal Reflux Disease (GERD) onset
Time frame: 6 months post surgery
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)
4 secondary outcomes
hiatal hernia appearance
Time frame: 6 months post surgery
change in patient-reported quality of life using Gastroparesis Cardinal Symptom Index (GCSI) questionnaire
Time frame: baseline and 6 months post surgery
change in patient-reported quality of life using GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) questionnaire
Time frame: baseline and 6 months post surgery
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Garofalo principal investigator
EOC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPC and LSG in people with Gastroesophageal Reflux and Obesity, run by Fabio Garofalo at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
De novo GastroEsophageal Reflux Disease (GERD) onset (time frame: 6 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.