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

NCT03659487 | Completed

• 1 other identifier: EPN 225/01
• Study Type: interventional
• Target: 460
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reflux, Gastroesophageal

Outcome Measures

Primary Outcomes (1)

• Esophageal acid exposure

  24-hour pH measurement

  Change from baseline at 6 weeks, 12 and 36 month

Secondary Outcomes (2)

• Recurrens rates

  Change from baseline at 6 weeks, 12, 36 and 60 month

• Dysphagia scoring

  Change from baseline at 6 weeks, 12, 36 and 60 month

Study Arms (2)

Nissen

ACTIVE COMPARATOR

Surgery of GERD with 360 degrees total fundoplication

Procedure: Nissen

Toupét

ACTIVE COMPARATOR

Surgery of GERD with 270 degrees partial fundoplication

Procedure: Toupét

Interventions

Nissen PROCEDURE

Laparoscopic total (Nissen) fundoplication

Nissen

Toupét PROCEDURE

Laparoscopic posterior 270 degrees partial fundoplication

Toupét

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• surgery treatment for GERD
• laparoscopic surgery

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (1)

• 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.

  PMID: 30840057 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Anders Thorell, professor

  Karolinska Institut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Laparoscopic total (Nissen) vs posterior 270 degrees (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 6, 2018
• Study Start: November 1, 2001
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share