Condition category
Digestive System
Date applied
15/03/2010
Date assigned
10/03/2011
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.sahlgrenska.se

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21451393

Publication citations

  1. 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.

Additional files

Editorial Notes