Gastroesophageal RefluxNCT02618044
Laparoscopic Roux-en-Y Gastric Bypass and Gastro-esophageal Reflux
An observational study of Gastroesophageal Reflux and Obesity, run by University of Turin, Italy.
Trial summary
Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of choice for patients suffering of gastro-esophageal reflux (GER). However, long term instrumental evaluations of GER after LRYGB are not available. 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
- 86 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Jul 2015
- 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 LRYGB
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
About this study
Official title: Long Term Effects of Laparoscopic Roux-en-Y Gastric Bypass on Gastro-esophageal Reflux: Clinical Impact of Weakly Acidic Reflux
Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of choice for patients suffering of gastro-esophageal reflux (GER). However, long term instrumental evaluations of GER after LRYGB are not available.
The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on gastro-esophageal function.
Read the detailed description
Consecutive morbidly obese patients selected for LRYGB were included in a prospective study. The investigators performed clinical evaluation with GERD-HRQoL and GIS questionnaire, upper endoscopy, esophageal manometry and 24h-impedance pH monitoring (24h-MII-pH) preoperatively and at 12 and 60 months after surgery. Patients were divided into 2 groups according to the presence of GER at preoperative 24h-MII-pH.
- Conditions
- Gastroesophageal Reflux, Obesity
- Keywords
- Gastroesophageal reflux, Obesity, Esophageal manometry, 24 H impedance pH-monitoring, Laparoscopic Roux-en-Y Gastric Bypass
- 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 without preoperative GER | Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass without preoperative GER at 24h-impedance pH monitoring (Group G-) | |
| Obese patients with preoperative GER | Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass with preoperative GER at 24h-impedance pH monitoring (Group G+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of weakly acidic reflux
number of weakly acidic reflux at 24 hour pH impedance monitoring
Measured: preoperatively, 12 and 60 months after LRYGB
Secondary outcomes (5)
GERD-HRQoL clinical score
Standard and previous validated questionnaire was employed in the study to assess gastroesophageal function and quality of life
Measured: preoperatively, 12 and 60 months after LRYGB
Lower esophageal sphincter pressure
Esophageal manometry measures lower esophageal sphincter pressure
Measured: preoperatively, 12 and 60 months after LRYGB
Amplitude of esophageal peristaltic waves
Esophageal manometry evaluates amplitude of esophageal peristalsis
Measured: preoperatively, 12 and 60 months after LRYGB
Grade of esophagitis
Upper endoscopy is performed to assess the presence of esophagitis
Measured: preoperatively, 12 and 60 months after LRYGB
Number of acidic reflux
number of acidic reflux at 24 hour pH impedance monitoring
Measured: preoperatively, 12 and 60 months after LRYGB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startMay 2006
- Primary completionFeb 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 86 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618044
- Sponsor's protocol ID
- WAROB/97
- Status last verified
- Dec 2015
- First submitted
- 24 Nov 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vela MF. Non-acid reflux: detection by multichannel intraluminal impedance and pH, clinical significance and management. Am J Gastroenterol. 2009 Feb;104(2):277-80. doi: 10.1038/ajg.2008.23. No abstract available.
PubMed 19190606Sundbom M, Hedenstrom H, Gustavsson S. Duodenogastric bile reflux after gastric bypass: a cholescintigraphic study. Dig Dis Sci. 2002 Aug;47(8):1891-6. doi: 10.1023/a:1016429603337.
PubMed 12184547Collard JM, Romagnoli R. Roux-en-Y jejunal loop and bile reflux. Am J Surg. 2000 Apr;179(4):298-303. doi: 10.1016/s0002-9610(00)00326-3.
PubMed 10875990Mabrut JY, Collard JM, Romagnoli R, Gutschow C, Salizzoni M. Oesophageal and gastric bile exposure after gastroduodenal surgery with Henley's interposition or a Roux-en-Y loop. Br J Surg. 2004 May;91(5):580-5. doi: 10.1002/bjs.4569.
PubMed 15122609Barak N, Ehrenpreis ED, Harrison JR, Sitrin MD. Gastro-oesophageal reflux disease in obesity: pathophysiological and therapeutic considerations. Obes Rev. 2002 Feb;3(1):9-15. doi: 10.1046/j.1467-789x.2002.00049.x.
PubMed 12119661Rebecchi F, Allaix ME, Ugliono E, Giaccone C, Toppino M, Morino M. Increased Esophageal Exposure to Weakly Acidic Reflux 5 Years After Laparoscopic Roux-en-Y Gastric Bypass. Ann Surg. 2016 Nov;264(5):871-877. doi: 10.1097/SLA.0000000000001775.
PubMed 27429035
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Laparoscopic Roux-en-Y Gastric Bypass on Gastro-esophageal Reflux: Clinical Impact of Weakly Acidic Reflux
- ClinicalTrials.gov ID
- NCT02618044
- Acronym / sponsor ID
- WAROB/97
- Conditions
- Gastroesophageal Reflux, Obesity
- Keywords
- Gastroesophageal reflux, Obesity, Esophageal manometry, 24 H impedance pH-monitoring, Laparoscopic Roux-en-Y Gastric Bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Dec 2015 (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.
Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of choice for patients suffering of gastro-esophageal reflux (GER). However, long term instrumental evaluations of GER after LRYGB are not available.
The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on gastro-esophageal function.
Detailed description
Consecutive morbidly obese patients selected for LRYGB were included in a prospective study. The investigators performed clinical evaluation with GERD-HRQoL and GIS questionnaire, upper endoscopy, esophageal manometry and 24h-impedance pH monitoring (24h-MII-pH) preoperatively and at 12 and 60 months after surgery. Patients were divided into 2 groups according to the presence of GER at preoperative 24h-MII-pH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients without preoperative GER | – | –Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass without preoperative GER at 24h-impedance pH monitoring (Group G-) |
| Obese patients with preoperative GER | – | –Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass with preoperative GER at 24h-impedance pH monitoring (Group G+) |
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 LRYGB
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
Number of weakly acidic reflux
Time frame: preoperatively, 12 and 60 months after LRYGB
number of weakly acidic reflux at 24 hour pH impedance monitoring
5 secondary outcomes
GERD-HRQoL clinical score
Time frame: preoperatively, 12 and 60 months after LRYGB
Lower esophageal sphincter pressure
Time frame: preoperatively, 12 and 60 months after LRYGB
Amplitude of esophageal peristaltic waves
Time frame: preoperatively, 12 and 60 months after LRYGB
Grade of esophagitis
Time frame: preoperatively, 12 and 60 months after LRYGB
Number of acidic reflux
Time frame: preoperatively, 12 and 60 months after LRYGB
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 3 Dec 2015.
- Results publication: PubMed 19190606Vela MF. Non-acid reflux: detection by multichannel intraluminal impedance and pH, clinical significance and management. Am J Gastroenterol. 2009 Feb;104(2):277-80. doi: 10.1038/ajg.2008.23. No abstract available.
- Results publication: PubMed 12184547Sundbom M, Hedenstrom H, Gustavsson S. Duodenogastric bile reflux after gastric bypass: a cholescintigraphic study. Dig Dis Sci. 2002 Aug;47(8):1891-6. doi: 10.1023/a:1016429603337.
- Results publication: PubMed 10875990Collard JM, Romagnoli R. Roux-en-Y jejunal loop and bile reflux. Am J Surg. 2000 Apr;179(4):298-303. doi: 10.1016/s0002-9610(00)00326-3.
- Results publication: PubMed 15122609Mabrut JY, Collard JM, Romagnoli R, Gutschow C, Salizzoni M. Oesophageal and gastric bile exposure after gastroduodenal surgery with Henley's interposition or a Roux-en-Y loop. Br J Surg. 2004 May;91(5):580-5. doi: 10.1002/bjs.4569.
- Results publication: PubMed 12119661Barak N, Ehrenpreis ED, Harrison JR, Sitrin MD. Gastro-oesophageal reflux disease in obesity: pathophysiological and therapeutic considerations. Obes Rev. 2002 Feb;3(1):9-15. doi: 10.1046/j.1467-789x.2002.00049.x.
- Derived from this study: PubMed 27429035Rebecchi F, Allaix ME, Ugliono E, Giaccone C, Toppino M, Morino M. Increased Esophageal Exposure to Weakly Acidic Reflux 5 Years After Laparoscopic Roux-en-Y Gastric Bypass. Ann Surg. 2016 Nov;264(5):871-877. doi: 10.1097/SLA.0000000000001775.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux and Obesity, run by University of Turin, 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of weakly acidic reflux (time frame: preoperatively, 12 and 60 months after LRYGB). 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 NCT02618044, which also lists 6 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 3 Dec 2015.