Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD

Summary Background Until recently only two therapeutic options have been available to control symptoms and the esophagitis in chronic gastro‐oesophageal reflux disease (GERD), i.e. lifelong proton pump inhibitor (PPI) therapy or anti‐reflux surgery. Lately, transoral incisionless fundoplication (TIF...

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Published in:	Alimentary pharmacology & therapeutics Vol. 42; no. 11-12; pp. 1261 - 1270
Main Authors:	Håkansson, B., Montgomery, M., Cadiere, G. B., Rajan, A., Bruley des Varannes, S., Lerhun, M., Coron, E., Tack, J., Bischops, R., Thorell, A., Arnelo, U., Lundell, L.
Format:	Journal Article
Language:	English
Published:	England 01-12-2015
Subjects:	Adult Aged Double-Blind Method Esophagitis, Peptic - surgery Female Fundoplication - instrumentation Fundoplication - methods Gastroesophageal Reflux - surgery Humans Male Medicin och hälsovetenskap Middle Aged Quality of Life Treatment Outcome Young Adult
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Summary:	Summary Background Until recently only two therapeutic options have been available to control symptoms and the esophagitis in chronic gastro‐oesophageal reflux disease (GERD), i.e. lifelong proton pump inhibitor (PPI) therapy or anti‐reflux surgery. Lately, transoral incisionless fundoplication (TIF) has been developed and found to offer a therapeutic alternative for these patients. Aim To perform a double‐blind sham‐controlled study in GERD patients who were chronic PPI users. Methods We studied patients with objectively confirmed GERD and persistent moderate to severe GERD symptoms without PPI therapy. Of 121 patients screened, we finally randomised 44 patients with 22 patients in each group. Those allocated to TIF had the TIF2 procedure completed during general anaesthesia by the EsophyX device with SerosaFuse fasteners. The sham procedure consisted of upper GI endoscopy under general anaesthesia. Neither the patient nor the assessor was aware of the patients' group affiliation. The primary effectiveness endpoint was the proportion of patients in clinical remission after 6‐month follow‐up. Secondary outcomes were: PPI consumption, oesophageal acid exposure, reduction in Quality of Life in Reflux and Dyspepsia and Gastrointestinal Symptom Rating Scale scores and healing of reflux esophagitis. Results The time (average days) in remission offered by the TIF2 procedure (197) was significantly longer compared to those submitted to the sham intervention (107), P < 0.001. After 6 months 13/22 (59%) of the chronic GERD patients remained in clinical remission after the active intervention. Likewise, the secondary outcome measures were all in favour of the TIF2 procedure. No safety issues were raised. Conclusion Transoral incisionless fundoplication (TIF2) is effective in chronic PPI‐dependent GERD patients when followed up for 6 months. Clinicaltrials.gov: CT01110811
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23
ISSN:	0269-2813 1365-2036 1365-2036
DOI:	10.1111/apt.13427