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

Karolinska Institute

Status: Completed

Conditions: Reflux, Gastroesophageal

Treatments: Procedure: Nissen; Procedure: Toupét

Study type: Interventional

Funder types: Other

Identifiers

NCT03659487

EPN 225/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 460 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• surgery treatment for GERD
• laparoscopic surgery

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 2 patient groups

Nissen

Active Comparator group

Description:

Surgery of GERD with 360 degrees total fundoplication

Treatment:

Procedure: Nissen

Toupét

Active Comparator group

Description:

Surgery of GERD with 270 degrees partial fundoplication

Treatment:

Procedure: Toupét