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

Reflux, Gastroesophageal Clinical Trial

— RefluxII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659487
• Other study ID #: EPN 225/01
• Status: Completed
• Phase: N/A
• Start date: November 2001
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: October 2018
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• surgery treatment for GERD

• laparoscopic surgery

Exclusion Criteria:

• previous surgery for GERD

• ASA classification >3

• paraesophageal hernias or large hiatal

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Reflux, Gastroesophageal

Intervention

Procedure:
• Nissen
Laparoscopic total (Nissen) fundoplication
• Toupét
Laparoscopic posterior 270 degrees partial fundoplication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal acid exposure	24-hour pH measurement	Change from baseline at 6 weeks, 12 and 36 month
Secondary	Recurrens rates	Medical journal or patients description	Change from baseline at 6 weeks, 12, 36 and 60 month
Secondary	Dysphagia scoring	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.	Change from baseline at 6 weeks, 12, 36 and 60 month