Gastroesophageal RefluxNCT02012894
Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux
An observational study of Gastroesophageal Reflux and Obesity, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroesophageal Reflux, Obesity
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to Sep 2013
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Consecutive morbidly obese patients selected for LSG
Who may be able to join
- history of obesity exceeding 5 years
- documented previous weight loss attempts,
- body mass index (BMI)) of 40-50 kg/m2
- age of 18-60 years.
Who cannot join
- contraindications to pneumoperitoneum
- large esophageal hiatal hernia
- pregnancy,
- drug or alcohol abuse,
- psychological disorders (e.g., bulimia, depression)
- hormonal or genetic obesity-related disease,
- previous gastric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy
Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking.
The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.
Read the detailed description
Consecutive morbidly obese patients selected for LSG are included in a prospective clinical study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.
- Conditions
- Gastroesophageal Reflux, Obesity
- Keywords
- Obesity, Gastroesophageal reflux, sleeve gastrectomy, pH-monitoring, manometry
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients with preoperative GER | Obese patients selected for laparoscopic sleeve gastrectomy with preoperative GER at 24 H pH-monitoring (Group A) | |
| Obese patients without preoperative GER | Obese patients selected for laparoscopic sleeve gastrectomy without preoperative GER at 24 H pH-monitoring (Group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in DeMeester's score
Use of the composite score that evaluates GER at 24-h pH monitoring before and 24 months after LSG. It includes numbers of reflux episodes, upright time in reflux, recumbent time in reflux, total time in reflux, reflux episodes over 5 minutes, longest reflux episodes
Measured: baseline, 24 months after LSG
Secondary outcomes (4)
Change from baseline in lower esophageal sphincter pressure
Esophageal manometry measures several parameters including lower esophageal sphincter pressure
Measured: baseline, 24 months after LSG
Change from baseline in amplitude of esophageal peristaltic waves
Esophageal manometry evaluates quality and amplitude of esophageal peristalsis
Measured: baseline, 24 months after LSG
Change from baseline in grade of esophagitis
Upper endoscopy is performed to assess preoperative and postoperative presence and severity of esophagitis
Measured: baseline, 24 months after LSG
Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score
Standard and validated questionnaire is used to assess gastroesophageal symptoms and quality of life
Measured: Baseline, 24 months after LSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJun 2009
- Primary completionSep 2011
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Rebecchi, University of Turin, Italy
- Investigators
- Fabrizio Rebecchi, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012894
- Sponsor's protocol ID
- RGEOB/76
- Status last verified
- Dec 2013
- First submitted
- 5 Dec 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tai CM, Huang CK, Lee YC, Chang CY, Lee CT, Lin JT. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Apr;27(4):1260-6. doi: 10.1007/s00464-012-2593-9. Epub 2012 Dec 12.
PubMed 23232995Petersen WV, Meile T, Kuper MA, Zdichavsky M, Konigsrainer A, Schneider JH. Functional importance of laparoscopic sleeve gastrectomy for the lower esophageal sphincter in patients with morbid obesity. Obes Surg. 2012 Mar;22(3):360-6. doi: 10.1007/s11695-011-0536-5.
PubMed 22065341Mahawar KK, Jennings N, Balupuri S, Small PK. Sleeve gastrectomy and gastro-oesophageal reflux disease: a complex relationship. Obes Surg. 2013 Jul;23(7):987-91. doi: 10.1007/s11695-013-0899-x.
PubMed 23460263Rebecchi F, Allaix ME, Giaccone C, Ugliono E, Scozzari G, Morino M. Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. Ann Surg. 2014 Nov;260(5):909-14; discussion 914-5. doi: 10.1097/SLA.0000000000000967.
PubMed 25379861
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02012894
- Acronym / sponsor ID
- RGEOB/76
- Conditions
- Gastroesophageal Reflux, Obesity
- Keywords
- Obesity, Gastroesophageal reflux, sleeve gastrectomy, pH-monitoring, manometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Dec 2013 (estimated)
- 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.
Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking.
The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.
Detailed description
Consecutive morbidly obese patients selected for LSG are included in a prospective clinical study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients with preoperative GER | – | –Obese patients selected for laparoscopic sleeve gastrectomy with preoperative GER at 24 H pH-monitoring (Group A) |
| Obese patients without preoperative GER | – | –Obese patients selected for laparoscopic sleeve gastrectomy without preoperative GER at 24 H pH-monitoring (Group B) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Consecutive morbidly obese patients selected for LSG
Key inclusion criteria (4 listed)
- history of obesity exceeding 5 years
- documented previous weight loss attempts,
- body mass index (BMI)) of 40-50 kg/m2
- age of 18-60 years.
Key exclusion criteria (7 listed)
- contraindications to pneumoperitoneum
- large esophageal hiatal hernia
- pregnancy,
- drug or alcohol abuse,
- psychological disorders (e.g., bulimia, depression)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in DeMeester's score
Time frame: baseline, 24 months after LSG
Use of the composite score that evaluates GER at 24-h pH monitoring before and 24 months after LSG. It includes numbers of reflux episodes, upright time in reflux, recumbent time in reflux, total time in reflux, reflux episodes over 5 minutes, longest reflux episodes
4 secondary outcomes
Change from baseline in lower esophageal sphincter pressure
Time frame: baseline, 24 months after LSG
Change from baseline in amplitude of esophageal peristaltic waves
Time frame: baseline, 24 months after LSG
Change from baseline in grade of esophagitis
Time frame: baseline, 24 months after LSG
Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score
Time frame: Baseline, 24 months after LSG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Background: PubMed 23232995Tai CM, Huang CK, Lee YC, Chang CY, Lee CT, Lin JT. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Apr;27(4):1260-6. doi: 10.1007/s00464-012-2593-9. Epub 2012 Dec 12.
- Background: PubMed 22065341Petersen WV, Meile T, Kuper MA, Zdichavsky M, Konigsrainer A, Schneider JH. Functional importance of laparoscopic sleeve gastrectomy for the lower esophageal sphincter in patients with morbid obesity. Obes Surg. 2012 Mar;22(3):360-6. doi: 10.1007/s11695-011-0536-5.
- Background: PubMed 23460263Mahawar KK, Jennings N, Balupuri S, Small PK. Sleeve gastrectomy and gastro-oesophageal reflux disease: a complex relationship. Obes Surg. 2013 Jul;23(7):987-91. doi: 10.1007/s11695-013-0899-x.
- Derived from this study: PubMed 25379861Rebecchi F, Allaix ME, Giaccone C, Ugliono E, Scozzari G, Morino M. Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. Ann Surg. 2014 Nov;260(5):909-14; discussion 914-5. doi: 10.1097/SLA.0000000000000967.
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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.
Fabrizio Rebecchi, MD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux and Obesity, run by University of Turin, Italy at 1 site in Italy.
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 7 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: finished, as of the sponsor's last update on 16 Dec 2013. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in DeMeester's score (time frame: baseline, 24 months after LSG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02012894, which also lists 4 linked publications.
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 16 Dec 2013.