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Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741441
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
Fabrizio Rebecchi, University of Turin, Italy

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.


Condition or disease Intervention/treatment
Duodenogastric Reflux Procedure: laparoscopic total fundoplication

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.

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Study Type : Observational
Actual Enrollment : 188 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Prognostic Factors for Long Term Results of Total Laparoscopic Fundoplication for Weakly Acidic or Mixed Reflux
Study Start Date : June 2002
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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.
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.
Other Names:
  • Laparoscopic Nissen fundoplication
  • Laparoscopic 360° degree fundoplication




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Gastro-esophageal junction pressure [ Time Frame: 60 months after surgery ]
    Gastroesophageal junction pressure was evaluated with esophageal manometry

  3. Gastric emptying [ Time Frame: 1 months before surgery ]
    Gastric emptying was evaluated with gastric scintigraphy before LTF



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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741441


Locations
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Italy
Digestive, Colorectal, Oncologic and Minimally Invasive Surgery, Department of Surgical Sciences
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Investigators
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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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fabrizio Rebecchi, Medical Doctor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01741441    
Other Study ID Numbers: LTF-2002-TO
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: November 2012
Keywords provided by Fabrizio Rebecchi, University of Turin, Italy:
Duodenogastroesophageal reflux
Weakly acidic reflux
Gastric emptying
Laparoscopic fundoplication
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Duodenogastric Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Duodenal Diseases
Intestinal Diseases
Stomach Diseases