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

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT03659487

Collaborator

(none)

460

Enrollment

Arms

203

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Reflux, Gastroesophageal	Procedure: Nissen Procedure: Toupét	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

460 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2001

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nissen Surgery of GERD with 360 degrees total fundoplication	Procedure: Nissen Laparoscopic total (Nissen) fundoplication
Active Comparator: Toupét Surgery of GERD with 270 degrees partial fundoplication	Procedure: Toupét Laparoscopic posterior 270 degrees partial fundoplication

Arm

Intervention/Treatment

Active Comparator: Nissen

Surgery of GERD with 360 degrees total fundoplication

Procedure: Nissen

Laparoscopic total (Nissen) fundoplication

Active Comparator: Toupét

Surgery of GERD with 270 degrees partial fundoplication

Procedure: Toupét

Laparoscopic posterior 270 degrees partial fundoplication

Outcome Measures

Primary Outcome Measures

Esophageal acid exposure [Change from baseline at 6 weeks, 12 and 36 month]
24-hour pH measurement

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

surgery treatment for GERD
laparoscopic surgery

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Karolinska Institutet

Investigators

Principal Investigator: Anders Thorell, professor, Karolinska Institut

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anders Thorell, Professor, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT03659487

Other Study ID Numbers:

EPN 225/01

First Posted:

Sep 6, 2018

Last Update Posted:

Oct 29, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastroesophageal Reflux

Study Results

No Results Posted as of Oct 29, 2018