Clinical Trial: Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Study of Prognostic Factors for Long Term Results of Total Laparoscopic Fundoplication for Weakly Acidic or Mixed Reflux

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 Summary:

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.


Sponsor: University of Turin, Italy

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • GERD Health related quality of Life score [ Time Frame: 60 months after LTF ]
    Standard and previous validate questionnaire was employed in the study to assess gastroesophageal function and quality of life
  • Gastro-esophageal junction pressure [ Time Frame: 60 months after surgery ]
    Gastroesophageal junction pressure was evaluated with esophageal manometry
  • Gastric emptying [ Time Frame: 1 months before surgery ]
    Gastric emptying was evaluated with gastric scintigraphy before LTF


Original Secondary Outcome: Same as current

Information By: University of Turin, Italy

Dates:
Date Received: November 25, 2012
Date Started: June 2002
Date Completion:
Last Updated: November 30, 2012
Last Verified: November 2012