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

NCT ID: NCT03659487

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2018-10-31

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.

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.

Conditions

Reflux, Gastroesophageal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nissen

Surgery of GERD with 360 degrees total fundoplication

Group Type: ACTIVE_COMPARATOR

Nissen

Intervention Type: PROCEDURE

Laparoscopic total (Nissen) fundoplication

Toupét

Surgery of GERD with 270 degrees partial fundoplication

Group Type: ACTIVE_COMPARATOR

Toupét

Intervention Type: PROCEDURE

Laparoscopic posterior 270 degrees partial fundoplication

Interventions

Nissen

Laparoscopic total (Nissen) fundoplication

Intervention Type: PROCEDURE

Toupét

Laparoscopic posterior 270 degrees partial fundoplication

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• surgery treatment for GERD
• laparoscopic surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Anders Thorell

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders Thorell, professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institut

References

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.

Reference Type: DERIVED

PMID: 30840057 (View on PubMed)

Other Identifiers

EPN 225/01

Identifier Type: -

Identifier Source: org_study_id