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

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.

Study Overview

• Status: Completed
• Conditions: Reflux, Gastroesophageal
• Intervention / Treatment: Procedure: Nissen; Procedure: Toupét

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 460
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• surgery treatment for GERD
• laparoscopic surgery

Exclusion Criteria:

• previous surgery for GERD
• ASA classification >3
• paraesophageal hernias or large hiatal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nissen; Surgery of GERD with 360 degrees total fundoplication	Procedure: Nissen; Laparoscopic total (Nissen) fundoplication
Active Comparator: Toupét; Surgery of GERD with 270 degrees partial fundoplication	Procedure: Toupét; Laparoscopic posterior 270 degrees partial fundoplication

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Anders Thorell, professor, Karolinska Institut

Publications and helpful links

General Publications

• Hakanson BS, Lundell L, Bylund A, Thorell A. Comparison of Laparoscopic 270 degrees Posterior Partial Fundoplication vs Total Fundoplication for the Treatment of Gastroesophageal Reflux Disease: A Randomized Clinical Trial. JAMA Surg. 2019 Jun 1;154(6):479-486. doi: 10.1001/jamasurg.2019.0047.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2001
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: EPN 225/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No