Contact information
Type
Scientific
Primary contact
Dr Cecilia Engström
ORCID ID
Contact details
Per Dubb gatan
Göteborg
413045
Sweden
+46 (0)31 342 10 00
cecilia.engstrom@surgery.gu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Total or a posterior partial fundoplication in the treatment of gastroesophageal reflux disease (GERD): results of a randomised trial after two decades of follow up
Acronym
Study hypothesis
Differences in side effect and reflux control between open fundoplication total or partial, after 18 years of follow up of a earlier randomised controlled trial (RCT).
Ethics approval
Not provided at time of registration - please note that this is the follow-up of an RCT.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Gastroesophageal reflux disease (GERD)
Intervention
Surgery for GERD, total nissen or partial fundoplication. Please note that this is the follow-up for a RCT performed 20 years ago; the mean follow up has now reached 18 years. During these years 26% had died and 16% were unable to trace for follow up. Symptom outcomes were assessed by the use of validated self-reporting questionnaires.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Reflux control after 18 years
2. Side effects like gas bloat, dysphagia
Secondary outcome measures
Number of recurrences and reoperations
Overall trial start date
01/01/1990
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged from 18 to 75 years, either sex
2. Established gastroesophageal reflux referred for surgical treatment in the beginning of 1990
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
137
Participant exclusion criteria
1. Pregnant
2. No possibility of compliance in the study protocol
3. Addict
4. Unable to understand the circumstances or the RCT information
Recruitment start date
01/01/1990
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Sweden
Trial participating centre
Per Dubb gatan
Göteborg
413045
Sweden
Sponsor information
Organisation
Sahlgrenska University Hospital (Sweden)
Sponsor details
Per Dubb gatan
Göteborg
413 45
Sweden
+46 (0)31 342 10 00
cecilia.engstrom@surgery.gu.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Sahlgrenska University Hospital (Sweden) - Department of Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21451393
Publication citations
-
Results
Mardani J, Lundell L, Engström C, Total or posterior partial fundoplication in the treatment of GERD: results of a randomized trial after 2 decades of follow-up., Ann. Surg., 2011, 253, 5, 875-878, doi: 10.1097/SLA.0b013e3182171c48.