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

• ClinicalTrials.gov Identifier: NCT03659487
• Recruitment Status: Completed
• First Posted: September 6, 2018
• Last Update Posted: October 29, 2018
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Anders Thorell, Karolinska Institutet

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Reflux, Gastroesophageal	Procedure: Nissen; Procedure: Toupét	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 460 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Laparoscopic total (Nissen) vs posterior 270 degrees (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease
• Actual Study Start Date: November 2001
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: October 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Esophageal acid exposure [ Time Frame: Change from baseline at 6 weeks, 12 and 36 month ]
   24-hour pH measurement

Secondary Outcome Measures :

1. Recurrens rates [ Time Frame: Change from baseline at 6 weeks, 12, 36 and 60 month ]
   Medical journal or patients description
2. Dysphagia scoring [ Time Frame: Change from baseline at 6 weeks, 12, 36 and 60 month ]
   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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• surgery treatment for GERD
• laparoscopic surgery

Exclusion Criteria:

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

Contacts and Locations

Sponsors and Collaborators

Karolinska Institutet

Investigators

• Principal Investigator: Anders Thorell, professor; Karolinska Institut

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Håkanson BS, Lundell L, Bylund A, Thorell A. Comparison of Laparoscopic 270° 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.

• Responsible Party: Anders Thorell, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03659487
• Other Study ID Numbers: EPN 225/01
• First Posted: September 6, 2018
• Last Update Posted: October 29, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases