Duodenogastric RefluxNCT01741441
Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux
An observational study of Duodenogastric Reflux, run by University of Turin, Italy at 1 site in Italy.
Trial summary
After laparoscopic total fundoplication (LTF) 12-15% of patients have persistent reflux symptoms and 20-25% develop gas-related symptoms. Reflux symptoms, gas bloating and inability to belch occurring after surgery have been associated with mixed (acid and weakly acid) (MR) or weakly acidic reflux (WAR). Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Duodenogastric Reflux
- What is being tested?
- laparoscopic total fundoplication
- Type of treatment
- Surgery or procedure
- How many people
- 188 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2002to Jun 2012
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Between June 2002 and June 2007 188 patients with MR and WAR underwent LTF; 172 (91.5%) completed the 5-year protocol. Among them, forty-two (24.4%) had preoperative moderately delayed GE (DGE).
Who may be able to join
- The study population consisted of consecutive patients with weakly acidic gastroesophageal reflux (GER) confirmed by 24 hour pH and impedance monitoring and eligible for laparoscopic antireflux surgery (LARS).
Who cannot join
- Exclusion criteria were presence of severe gastric emptying, functional heartburn, giant hiatal hernia, underlying primary esophageal motility disorder, American Association of Anaesthetists (ASA) score IV, previous upper abdominal surgery, and contraindications to pneumoperitoneum.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Digestive, Colorectal, Oncologic and Minimally Invasive Surgery, Department of Surgical Sciences
Turin, 10126
About this study
Official title: Study of Prognostic Factors for Long Term Results of Total Laparoscopic Fundoplication for Weakly Acidic or Mixed Reflux
After laparoscopic total fundoplication (LTF) 12-15% of patients have persistent reflux symptoms and 20-25% develop gas-related symptoms. Reflux symptoms, gas bloating and inability to belch occurring after surgery have been associated with mixed (acid and weakly acid) (MR) or weakly acidic reflux (WAR). To date, few studies have evaluated functional outcome after LTF in patients with MR or WAR, with the majority reporting only short-term results.
It has been shown that delayed gastric emptying (DGE) might also be an important factor for abdominal distension and adverse outcome after LTF.9,10 However, the correlation between poor long-term outcome after LTF and DGE is controversial. In addition, the effect of DGE in patients with MR or WAR is poorly investigated.
Read the detailed description
In the last years the study of gastro-oesophageal reflux has been revolutionized by the development of combined 24-h esophageal pH and multichannel intraluminal impedance (MII) monitoring.
Combined esophageal MII and pH-monitoring allow for the timed correlation of esophageal pH changes with reflux events and achieve high sensitivity for the detection of acid (pH <4), weakly acidic (pH 4-7) and weakly alkaline (pH >7) reflux episodes. Use of this technology is bringing into focus the potential role of weakly acidic and weakly alkaline reflux in symptoms that persist despite acid suppressive therapy or anti-reflux surgery.
- Conditions
- Duodenogastric Reflux
- Being tested
- laparoscopic total fundoplication
- Keywords
- Duodenogastroesophageal reflux, Weakly acidic reflux, Gastric emptying, Laparoscopic fundoplication
- Medical subject headings
- Duodenogastric Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic total fundoplicationProcedure or surgery
Also called Laparoscopic Nissen fundoplication, Laparoscopic 360° degree fundoplication
LTF was performed using a standard five-trocar technique in all cases and carried out by two expert surgeons who had previously performed more than 50 laparoscopic fundoplications. A floppy 360° total fundoplication of 2-2,5 cm was constructed after full esophageal mobilization and posterior crural repair with nonabsorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| WAR and MR patients | Consecutive patients with MR and WAR selected for laparoscopic total fundoplication (LTF) were included in a prospective clinical study. Gastroesophageal function was assessed by clinical validated questionnaires, upper endoscopy, esophageal manometry and 24-h impedance pH monitoring before and 12 and 60 months after LTF. Gastric scintigraphy was preoperatively performed in all patients. Receives: Procedure: laparoscopic total fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of acidic and weakly acidic reflux
number of acidic and weakly acidic reflux at 24 hour pH impedance monitoring
Measured: 60 months after LTF
Secondary outcomes (3)
GERD Health related quality of Life score
Standard and previous validate questionnaire was employed in the study to assess gastroesophageal function and quality of life
Measured: 60 months after LTF
Gastro-esophageal junction pressure
Gastroesophageal junction pressure was evaluated with esophageal manometry
Measured: 60 months after surgery
Gastric emptying
Gastric emptying was evaluated with gastric scintigraphy before LTF
Measured: 1 months before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJun 2002
- Primary completionJun 2007
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Duodenogastric 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
- 188 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, ItalyMario Morino, MD, Study director, University of Turin, ItalyMarco Ettore Allaix, MD, Study chair, University of Turin, ItalyClaudio Giaccone, MD, Study chair, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741441
- Sponsor's protocol ID
- LTF-2002-TO
- Status last verified
- Nov 2012
- First submitted
- 25 Nov 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Broeders JA, Mauritz FA, Ahmed Ali U, Draaisma WA, Ruurda JP, Gooszen HG, Smout AJ, Broeders IA, Hazebroek EJ. Systematic review and meta-analysis of laparoscopic Nissen (posterior total) versus Toupet (posterior partial) fundoplication for gastro-oesophageal reflux disease. Br J Surg. 2010 Sep;97(9):1318-30. doi: 10.1002/bjs.7174.
PubMed 20641062Broeders JA, Bredenoord AJ, Hazebroek EJ, Broeders IA, Gooszen HG, Smout AJ. Reflux and belching after 270 degree versus 360 degree laparoscopic posterior fundoplication. Ann Surg. 2012 Jan;255(1):59-65. doi: 10.1097/SLA.0b013e31823899f8.
PubMed 22167002Broeders JA, Bredenoord AJ, Hazebroek EJ, Broeders IA, Gooszen HG, Smout AJ. Effects of anti-reflux surgery on weakly acidic reflux and belching. Gut. 2011 Apr;60(4):435-41. doi: 10.1136/gut.2010.224824. Epub 2010 Dec 30.
PubMed 21193452Namasivayam V, Arora AS, Murray JA. Weakly acidic reflux. Dis Esophagus. 2011 Jan;24(1):56-62. doi: 10.1111/j.1442-2050.2010.01100.x.
PubMed 20659138Frazzoni M, Conigliaro R, Melotti G. Reflux parameters as modified by laparoscopic fundoplication in 40 patients with heartburn/regurgitation persisting despite PPI therapy: a study using impedance-pH monitoring. Dig Dis Sci. 2011 Apr;56(4):1099-106. doi: 10.1007/s10620-010-1381-4. Epub 2010 Aug 25.
PubMed 20737211Frazzoni M, Conigliaro R, Melotti G. Weakly acidic refluxes have a major role in the pathogenesis of proton pump inhibitor-resistant reflux oesophagitis. Aliment Pharmacol Ther. 2011 Mar;33(5):601-6. doi: 10.1111/j.1365-2036.2010.04550.x. Epub 2010 Dec 29.
PubMed 21198705Castell DO, Murray JA, Tutuian R, Orlando RC, Arnold R. Review article: the pathophysiology of gastro-oesophageal reflux disease - oesophageal manifestations. Aliment Pharmacol Ther. 2004 Dec;20 Suppl 9:14-25. doi: 10.1111/j.1365-2036.2004.02238.x.
PubMed 15527461Boeckxstaens GE. Review article: the pathophysiology of gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2007 Jul 15;26(2):149-60. doi: 10.1111/j.1365-2036.2007.03372.x.
PubMed 17593062Nakos A, Kouklakis G, Pitiakoudis M, Zezos P, Efraimidou E, Giatromanolaki A, Polychronidis A, Liratzopoulos N, Sivridis E, Simopoulos K. The histological and immunohistochemical aspects of bile reflux in patients with gastroesophageal reflux disease. Gastroenterol Res Pract. 2011;2011:905872. doi: 10.1155/2011/905872. Epub 2011 Jul 24.
PubMed 21822428Rebecchi F, Giaccone C, Farinella E, Campaci R, Morino M. Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results. Ann Surg. 2008 Dec;248(6):1023-30. doi: 10.1097/SLA.0b013e318190a776.
PubMed 19092347Morino M, Giaccone C, Pellegrino L, Rebecchi F. Laparoscopic management of giant hiatal hernia: factors influencing long-term outcome. Surg Endosc. 2006 Jul;20(7):1011-6. doi: 10.1007/s00464-005-0550-6. Epub 2006 Jun 8.
PubMed 16763927Rebecchi F, Allaix ME, Giaccone C, Morino M. Gastric emptying as a prognostic factor for long-term results of total laparoscopic fundoplication for weakly acidic or mixed reflux. Ann Surg. 2013 Nov;258(5):831-6; discussion 836-7. doi: 10.1097/SLA.0b013e3182a6882a.
PubMed 24045453
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prognostic Factors for Long Term Results of Total Laparoscopic Fundoplication for Weakly Acidic or Mixed Reflux
- ClinicalTrials.gov ID
- NCT01741441
- Acronym / sponsor ID
- LTF-2002-TO
- Conditions
- Duodenogastric Reflux
- Keywords
- Duodenogastroesophageal reflux, Weakly acidic reflux, Gastric emptying, Laparoscopic fundoplication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Dec 2012 (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.
After laparoscopic total fundoplication (LTF) 12-15% of patients have persistent reflux symptoms and 20-25% develop gas-related symptoms. Reflux symptoms, gas bloating and inability to belch occurring after surgery have been associated with mixed (acid and weakly acid) (MR) or weakly acidic reflux (WAR). To date, few studies have evaluated functional outcome after LTF in patients with MR or WAR, with the majority reporting only short-term results.
It has been shown that delayed gastric emptying (DGE) might also be an important factor for abdominal distension and adverse outcome after LTF.9,10 However, the correlation between poor long-term outcome after LTF and DGE is controversial. In addition, the effect of DGE in patients with MR or WAR is poorly investigated.
Detailed description
In the last years the study of gastro-oesophageal reflux has been revolutionized by the development of combined 24-h esophageal pH and multichannel intraluminal impedance (MII) monitoring.
Combined esophageal MII and pH-monitoring allow for the timed correlation of esophageal pH changes with reflux events and achieve high sensitivity for the detection of acid (pH <4), weakly acidic (pH 4-7) and weakly alkaline (pH >7) reflux episodes. Use of this technology is bringing into focus the potential role of weakly acidic and weakly alkaline reflux in symptoms that persist despite acid suppressive therapy or anti-reflux surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WAR and MR patients | – | Procedure: laparoscopic total fundoplicationConsecutive patients with MR and WAR selected for laparoscopic total fundoplication (LTF) were included in a prospective clinical study. Gastroesophageal function was assessed by clinical validated questionnaires, upper endoscopy, esophageal manometry and 24-h impedance pH monitoring before and 12 and 60 months after LTF. Gastric scintigraphy was preoperatively performed in all patients. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between June 2002 and June 2007 188 patients with MR and WAR underwent LTF; 172 (91.5%) completed the 5-year protocol. Among them, forty-two (24.4%) had preoperative moderately delayed GE (DGE).
Key inclusion criteria (1 listed)
- The study population consisted of consecutive patients with weakly acidic gastroesophageal reflux (GER) confirmed by 24 hour pH and impedance monitoring and eligible for laparoscopic antireflux surgery (LARS).
Key exclusion criteria (1 listed)
- Exclusion criteria were presence of severe gastric emptying, functional heartburn, giant hiatal hernia, underlying primary esophageal motility disorder, American Association of Anaesthetists (ASA) score IV, previous upper abdominal surgery, and contraindications to pneumoperitoneum.
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 |
|---|---|---|
| laparoscopic total fundoplicationAlso: Laparoscopic Nissen fundoplication, Laparoscopic 360° degree fundoplicationLTF was performed using a standard five-trocar technique in all cases and carried out by two expert surgeons who had previously performed more than 50 laparoscopic fundoplications. A floppy 360° total fundoplication of 2-2,5 cm was constructed after full esophageal mobilization and posterior crural repair with nonabsorbable sutures. | Procedure or surgery | WAR and MR patients |
Primary outcome
number of acidic and weakly acidic reflux
Time frame: 60 months after LTF
number of acidic and weakly acidic reflux at 24 hour pH impedance monitoring
3 secondary outcomes
GERD Health related quality of Life score
Time frame: 60 months after LTF
Gastro-esophageal junction pressure
Time frame: 60 months after surgery
Gastric emptying
Time frame: 1 months before surgery
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 5 Dec 2012.
- Background: PubMed 20641062Broeders JA, Mauritz FA, Ahmed Ali U, Draaisma WA, Ruurda JP, Gooszen HG, Smout AJ, Broeders IA, Hazebroek EJ. Systematic review and meta-analysis of laparoscopic Nissen (posterior total) versus Toupet (posterior partial) fundoplication for gastro-oesophageal reflux disease. Br J Surg. 2010 Sep;97(9):1318-30. doi: 10.1002/bjs.7174.
- Background: PubMed 22167002Broeders JA, Bredenoord AJ, Hazebroek EJ, Broeders IA, Gooszen HG, Smout AJ. Reflux and belching after 270 degree versus 360 degree laparoscopic posterior fundoplication. Ann Surg. 2012 Jan;255(1):59-65. doi: 10.1097/SLA.0b013e31823899f8.
- Background: PubMed 21193452Broeders JA, Bredenoord AJ, Hazebroek EJ, Broeders IA, Gooszen HG, Smout AJ. Effects of anti-reflux surgery on weakly acidic reflux and belching. Gut. 2011 Apr;60(4):435-41. doi: 10.1136/gut.2010.224824. Epub 2010 Dec 30.
- Background: PubMed 20659138Namasivayam V, Arora AS, Murray JA. Weakly acidic reflux. Dis Esophagus. 2011 Jan;24(1):56-62. doi: 10.1111/j.1442-2050.2010.01100.x.
- Background: PubMed 20737211Frazzoni M, Conigliaro R, Melotti G. Reflux parameters as modified by laparoscopic fundoplication in 40 patients with heartburn/regurgitation persisting despite PPI therapy: a study using impedance-pH monitoring. Dig Dis Sci. 2011 Apr;56(4):1099-106. doi: 10.1007/s10620-010-1381-4. Epub 2010 Aug 25.
- Background: PubMed 21198705Frazzoni M, Conigliaro R, Melotti G. Weakly acidic refluxes have a major role in the pathogenesis of proton pump inhibitor-resistant reflux oesophagitis. Aliment Pharmacol Ther. 2011 Mar;33(5):601-6. doi: 10.1111/j.1365-2036.2010.04550.x. Epub 2010 Dec 29.
- Background: PubMed 15527461Castell DO, Murray JA, Tutuian R, Orlando RC, Arnold R. Review article: the pathophysiology of gastro-oesophageal reflux disease - oesophageal manifestations. Aliment Pharmacol Ther. 2004 Dec;20 Suppl 9:14-25. doi: 10.1111/j.1365-2036.2004.02238.x.
- Background: PubMed 17593062Boeckxstaens GE. Review article: the pathophysiology of gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2007 Jul 15;26(2):149-60. doi: 10.1111/j.1365-2036.2007.03372.x.
- Background: PubMed 21822428Nakos A, Kouklakis G, Pitiakoudis M, Zezos P, Efraimidou E, Giatromanolaki A, Polychronidis A, Liratzopoulos N, Sivridis E, Simopoulos K. The histological and immunohistochemical aspects of bile reflux in patients with gastroesophageal reflux disease. Gastroenterol Res Pract. 2011;2011:905872. doi: 10.1155/2011/905872. Epub 2011 Jul 24.
- Background: PubMed 19092347Rebecchi F, Giaccone C, Farinella E, Campaci R, Morino M. Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results. Ann Surg. 2008 Dec;248(6):1023-30. doi: 10.1097/SLA.0b013e318190a776.
- Background: PubMed 16763927Morino M, Giaccone C, Pellegrino L, Rebecchi F. Laparoscopic management of giant hiatal hernia: factors influencing long-term outcome. Surg Endosc. 2006 Jul;20(7):1011-6. doi: 10.1007/s00464-005-0550-6. Epub 2006 Jun 8.
- Derived from this study: PubMed 24045453Rebecchi F, Allaix ME, Giaccone C, Morino M. Gastric emptying as a prognostic factor for long-term results of total laparoscopic fundoplication for weakly acidic or mixed reflux. Ann Surg. 2013 Nov;258(5):831-6; discussion 836-7. doi: 10.1097/SLA.0b013e3182a6882a.
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
Mario Morino, MD study director
University of Turin, Italy
Marco Ettore Allaix, MD study chair
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 Duodenogastric Reflux, 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 1 inclusion and 1 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 5 Dec 2012. 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?
number of acidic and weakly acidic reflux (time frame: 60 months after LTF). 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 NCT01741441, which also lists 12 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 5 Dec 2012.