Duodenogastric Reflux Clinical Trial
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.
| Status | Completed |
| Enrollment | 188 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 14 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Digestive, Colorectal, Oncologic and Minimally Invasive Surgery, Department of Surgical Sciences | Turin |
| Lead Sponsor | Collaborator |
|---|---|
| University of Turin, Italy |
Italy,
Boeckxstaens GE. Review article: the pathophysiology of gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2007 Jul 15;26(2):149-60. Review. — View Citation
Broeders 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. — View Citation
Broeders 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. — View Citation
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. Review. — View Citation
Castell 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. Review. — View Citation
Frazzoni 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. — View Citation
Frazzoni 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. — View Citation
Morino 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. Epub 2006 Jun 8. — View Citation
Nakos 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. — View Citation
Namasivayam 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. Review. — View Citation
Rebecchi 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of acidic and weakly acidic reflux | number of acidic and weakly acidic reflux at 24 hour pH impedance monitoring | 60 months after LTF | No |
| Secondary | 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 | 60 months after LTF | No |
| Secondary | Gastro-esophageal junction pressure | Gastroesophageal junction pressure was evaluated with esophageal manometry | 60 months after surgery | No |
| Secondary | Gastric emptying | Gastric emptying was evaluated with gastric scintigraphy before LTF | 1 months before surgery | No |