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Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01741441
Enrollment
188
Registered
2012-12-05
Start date
2002-06-30
Completion date
2012-06-30
Last updated
2012-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenogastric Reflux

Keywords

Duodenogastroesophageal reflux, Weakly acidic reflux, Gastric emptying, Laparoscopic fundoplication

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 description

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.

Interventions

PROCEDURElaparoscopic 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

University of Turin, Italy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

\- The study population consisted of consecutive patients with weakly acidic gastroesophageal reflux (GER) confirmed by 24 hour pH and impedance monitoring and eligible for laparoscopic antireflux surgery (LARS).

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
number of acidic and weakly acidic reflux60 months after LTFnumber of acidic and weakly acidic reflux at 24 hour pH impedance monitoring

Secondary

MeasureTime frameDescription
GERD Health related quality of Life score60 months after LTFStandard and previous validate questionnaire was employed in the study to assess gastroesophageal function and quality of life
Gastro-esophageal junction pressure60 months after surgeryGastroesophageal junction pressure was evaluated with esophageal manometry
Gastric emptying1 months before surgeryGastric emptying was evaluated with gastric scintigraphy before LTF

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026