CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 188 enrolled
Drug / intervention
laparoscopic total fundoplicationprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01741441
NCT01741441N/ACompleted

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

University of Turin, Italy·observational·Posted Dec 5, 2012·Updated Dec 5, 2012

In Brief

An observational study evaluating laparoscopic total fundoplication for Duodenogastric Reflux. Completed, enrolled 188 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2012
Enrollment StartJun 1, 2002
Primary CompletionJun 1, 2007
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 13.6 years ago

Interventions

laparoscopic total fundoplicationprocedure

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.