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Long-term Outcome of Laparoscopic Nissen and Laparoscopic Toupet Fundoplication for Gastro-Esophageal Reflux Disease: a prospective, randomized trial.

Long-term Outcome of Laparoscopic Nissen and Laparoscopic Toupet Fundoplication for Gastro-Esophageal Reflux Disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000030279
Enrollment
100
Registered
2009-01-16
Start date
1997-04-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The primary purpose of the study is to compare two commonly performed anti-reflux surgical procedures and to assess whether there is any difference in long-term patient satisfaction between these two procedures

Interventions

A Laparoscopic Nissen fundoplication involves repair of the crural defect in the diaphragm, together with a 360 degree wrap of the fundus of the stomach around the lower end of the intra-abdominal oesophagus. This is performed laparoscopically and is a single intervention

Sponsors

Groote Schuur Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria 1. PPI(proton pump inhibitor) dependent, erosive reflux, OR 2. Volume reflux not responsive to PPI, AND 3. Willingness to undergo long-term follow-up AND 4. Willingness to sign informed consent 5. Abnormal motility included provided an absence of apersitalsis (achalasia)

Exclusion criteria

Exclusion Criteria 1. Esophageal stricture, or 2. Extra-esophageal symptoms unresponsive to PPI, or 3. Previous abdominal or gastric surgery, or 4. Surgically unfit patients, or 5. Refusal to undergo long-term follow-up, or 6. Refusal or inability to sign informed consent, or 7. Age less than 18 years

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026