Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Duodenogastric Reflux

Intervention / Treatment
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* Procedure: laparoscopic total fundoplication


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WAR and MR patients<br>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<br>* 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.<br>* Other names: Laparoscopic 360° degree fundoplication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of acidic and weakly acidic reflux | 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 | 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 | Gastroesophageal junction pressure was evaluated with esophageal manometry | 60 months after surgery | 
| Gastric emptying | Gastric emptying was evaluated with gastric scintigraphy before LTF | 1 months before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Duodenogastroesophageal reflux, Weakly acidic reflux, Gastric emptying, Laparoscopic fundoplication