Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux
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|ClinicalTrials.gov Identifier: NCT01741441|
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 5, 2012
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.
|Condition or disease||Intervention/treatment|
|Duodenogastric Reflux||Procedure: laparoscopic total fundoplication|
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 Type :||Observational|
|Actual Enrollment :||188 participants|
|Official Title:||Study of Prognostic Factors for Long Term Results of Total Laparoscopic Fundoplication for Weakly Acidic or Mixed Reflux|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2012|
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.
Procedure: laparoscopic total 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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741441
|Digestive, Colorectal, Oncologic and Minimally Invasive Surgery, Department of Surgical Sciences|
|Turin, Italy, 10126|
|Principal Investigator:||Fabrizio Rebecchi, MD||University of Turin, Italy|
|Study Director:||Mario Morino, MD||University of Turin, Italy|
|Study Chair:||Marco Ettore Allaix, MD||University of Turin, Italy|
|Study Chair:||Claudio Giaccone, MD||University of Turin, Italy|