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Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux

NCT01741441 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 188

Last updated 2012-12-05

No results posted yet for this study

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.

Conditions

  • Duodenogastric Reflux

Interventions

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.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Fabrizio Rebecchi, MD · University of Turin, Italy

  • Mario Morino, MD · University of Turin, Italy

  • Marco Ettore Allaix, MD · University of Turin, Italy

  • Claudio Giaccone, MD · University of Turin, Italy

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2007-06-30
Completion
2012-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01741441 on ClinicalTrials.gov