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

Not Applicable

Completed

• Conditions: Reflux, Gastroesophageal
• Interventions: Procedure: Nissen; Procedure: Toupét

• Registration Number: NCT03659487
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2011-04
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-06
• Status Verified: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

• surgery treatment for GERD
• laparoscopic surgery

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nissen	Nissen	Surgery of GERD with 360 degrees total fundoplication
Toupét	Toupét	Surgery of GERD with 270 degrees partial fundoplication

Primary Outcome Measures

Name	Time	Method
Esophageal acid exposure	Change from baseline at 6 weeks, 12 and 36 month	24-hour pH measurement

Secondary Outcome Measures

Name	Time	Method
Recurrens rates	Change from baseline at 6 weeks, 12, 36 and 60 month	Medical journal or patients description
Dysphagia scoring	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.