Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux

November 30, 2012 updated by: Fabrizio Rebecchi, University of Turin, Italy

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

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 Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Turin, Italy, 10126
        • Digestive, Colorectal, Oncologic and Minimally Invasive Surgery, Department of Surgical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Between June 2002 and June 2007 188 patients with MR and WAR underwent LTF; 172 (91.5%) completed the 5-year protocol. Among them, forty-two (24.4%) had preoperative moderately delayed GE (DGE).

Description

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:

- Exclusion criteria were presence of severe gastric emptying, functional heartburn, giant hiatal hernia, underlying primary esophageal motility disorder, American Association of Anaesthetists (ASA) score IV, previous upper abdominal surgery, and contraindications to pneumoperitoneum.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Laparoscopic Nissen fundoplication
  • Laparoscopic 360° degree fundoplication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 months after LTF

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 months after LTF
Gastro-esophageal junction pressure
Time Frame: 60 months after surgery
Gastroesophageal junction pressure was evaluated with esophageal manometry
60 months after surgery
Gastric emptying
Time Frame: 1 months before surgery
Gastric emptying was evaluated with gastric scintigraphy before LTF
1 months before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 25, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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