Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (GERD) participate in the study following the usual preoperative Clinical routines (Medical history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration ). Patients are randomized to fundoplication according to Nissen or modified Toupet. Postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.

Detailed Description
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Patients aged 18-75 years planned for elective surgical treatment of GERD participate in the study. Patients with recurrent reflux disease following prior surgery, ASA (American Society of Anesthesiologists (ASA) Physical Status) class> 3, paraesophageal herniating and / or major herniation without reflux and those with other contraindications against laparoscopic surgery are excluded. In addition, patient completes a QOL protocol. Patients in the study are randomized to laparoscopic fundoplication performed either with a 360 degrees (Nissen) alternatively 270 degree (modified Toupét). Both of these techniques are well established clinical routines. General intubation anesthesia is standardized to all study patients. Discharge from the hospital is typically on the first postoperative day. At a visit, after 6-8 weeks for clinical control, is a QOL protocol is completed as well. After 12 and 36 months, patients undergo upper endoscopy and manometry with 24 hour pH-registration and QOL protocol completion. The latter also occurs after 24 months and 60 months.

Official Title
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Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease

Conditions
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Reflux, Gastroesophageal

Intervention / Treatment
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* Procedure: Nissen
* Procedure: Toupét


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: surgery treatment for GERD laparoscopic surgery Exclusion Criteria: previous surgery for GERD ASA classification >3 paraesophageal hernias or large hiatal

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Laparoscopic total (Nissen) vs posterior 270 degrees (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nissen<br>Surgery of GERD with 360 degrees total fundoplication | Procedure: Nissen<br>* Laparoscopic total (Nissen) fundoplication<br>|
| Active Comparator: Toupét<br>Surgery of GERD with 270 degrees partial fundoplication | Procedure: Toupét<br>* Laparoscopic posterior 270 degrees partial fundoplication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal acid exposure | 24-hour pH measurement | Change from baseline at 6 weeks, 12 and 36 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrens rates | Medical journal or patients description | Change from baseline at 6 weeks, 12, 36 and 60 month | 
| Dysphagia scoring | Dysphagia for liquids and solids were recorded within a four-graded scale stating the frequency of dysphagia episodes with an arbitrary (empirical) cut off for clinical significance. The same dysphagia scoring was also used in a previous rct, from the same institution, comparing different types of antireflux procedures in open surgery. | Change from baseline at 6 weeks, 12, 36 and 60 month |