Total or a posterior partial fundoplication in the treatment of gastroesophageal reflux disease (GERD)

ISRCTN ISRCTN59614486
DOI https://doi.org/10.1186/ISRCTN59614486
Secondary identifying numbers N/A
Submission date
15/03/2010
Registration date
10/03/2011
Last edited
04/07/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Cecilia Engström
Scientific

Per Dubb gatan
Göteborg
413045
Sweden

Phone +46 (0)31 342 10 00
Email cecilia.engstrom@surgery.gu.se

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleTotal or a posterior partial fundoplication in the treatment of gastroesophageal reflux disease (GERD): results of a randomised trial after two decades of follow up
Study objectivesDifferences 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(s)Not provided at time of registration - please note that this is the follow-up of an RCT.
Health condition(s) or problem(s) studiedGastroesophageal reflux disease (GERD)
InterventionSurgery 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 typeOther
Primary outcome measure1. Reflux control after 18 years
2. Side effects like gas bloat, dysphagia
Secondary outcome measuresNumber of recurrences and reoperations
Overall study start date01/01/1990
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants137
Key inclusion criteria1. Aged from 18 to 75 years, either sex
2. Established gastroesophageal reflux referred for surgical treatment in the beginning of 1990
Key exclusion criteria1. Pregnant
2. No possibility of compliance in the study protocol
3. Addict
4. Unable to understand the circumstances or the RCT information
Date of first enrolment01/01/1990
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • Sweden

Study participating centre

Per Dubb gatan
Göteborg
413045
Sweden

Sponsor information

Sahlgrenska University Hospital (Sweden)
Hospital/treatment centre

Per Dubb gatan
Göteborg
413 45
Sweden

Phone +46 (0)31 342 10 00
Email cecilia.engstrom@surgery.gu.se
Website http://www.sahlgrenska.se
ROR logo "ROR" https://ror.org/04vgqjj36

Funders

Funder type

Hospital/treatment centre

Sahlgrenska University Hospital (Sweden) - Department of Surgery

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2011 Yes No