Clinical trial NCT01741441: Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux
Official title: Study of Prognostic Factors for Long Term Results of Total Laparoscopic Fundoplication for Weakly Acidic or Mixed Reflux
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenogastric Reflux
Keywords: Duodenogastroesophageal reflux
Weakly acidic reflux
Gastric emptying
Laparoscopic fundoplication
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 188
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of acidic and weakly acidic reflux
timeFrame: 60 months after LTF
Secondary outcomes:
measure: GERD Health related quality of Life score
timeFrame: 60 months after LTF
measure: Gastro-esophageal junction pressure
timeFrame: 60 months after surgery
measure: Gastric emptying
timeFrame: 1 months before surgery
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Digestive, Colorectal, Oncologic and Minimally Invasive Surgery, Department of Surgical Sciences
Study officials:
affiliation: University of Turin, Italy
name: Fabrizio Rebecchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Mario Morino, MD
role: STUDY_DIRECTOR
affiliation: University of Turin, Italy
name: Marco Ettore Allaix, MD
role: STUDY_CHAIR
affiliation: University of Turin, Italy
name: Claudio Giaccone, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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. doi: 10.1111/j.1365-2036.2004.02238.x.
citation: Boeckxstaens 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.
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.
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.
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. doi: 10.1007/s00464-005-0550-6. Epub 2006 Jun 8.
citation: Rebecchi 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.