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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03659487
Acronym
RefluxII
Enrollment
460
Registered
2018-09-06
Start date
2001-11-30
Completion date
2018-10-31
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux, Gastroesophageal

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.

Interventions

PROCEDURENissen

Laparoscopic total (Nissen) fundoplication

PROCEDUREToupét

Laparoscopic posterior 270 degrees partial fundoplication

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* surgery treatment for GERD * laparoscopic surgery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Esophageal acid exposureChange from baseline at 6 weeks, 12 and 36 month24-hour pH measurement

Secondary

MeasureTime frameDescription
Recurrens ratesChange from baseline at 6 weeks, 12, 36 and 60 monthMedical journal or patients description
Dysphagia scoringChange from baseline at 6 weeks, 12, 36 and 60 monthDysphagia 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026