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. 2015 Nov 5;2015(11):CD003243. doi: 10.1002/14651858.CD003243.pub3

Grant 2008.

Methods Randomised clinical trial
Participants Country: United Kingdom
Number randomised: 357
Post‐randomisation drop‐outs: not stated
Revised sample size: 357
Average age: 46 years
Females: 121 (33.9%)
Barretts oesophagus: not stated
Hiatus hernia: not stated
Body mass index: 29
Inclusion criteria
  1. More than 12 months’ symptoms requiring maintenance treatment with a proton pump inhibitor (or alternative) for reasonable control.

  2. Endoscopic or 24 hour pH monitoring evidence of GORD, or both.

  3. Suitable for either policy (including American Society of Anesthesiologists (ASA) grade I or II) and the recruiting doctor was uncertain which management policy to follow.


Exclusion criteria
  1. Morbid obesity (BMI > 40)

  2. Barrett’s oesophagus of more than 3 cm or with evidence of dysplasia.

  3. Para‐oesophageal hernia

  4. Oesophageal stricture

Interventions Participants were randomly assigned to two groups.
 Group 1: surgery (n = 178)
 Further details: Laparoscopic fundoplication as per surgeon preference.
 Group 2: medical treatment (n = 179)
 Further details: Medical treatment as per local protocol.
Outcomes The outcomes reported were health‐related quality of life, GORD‐specific quality of life, proportion with heartburn, reflux, and dysphagia.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Random allocation was organised centrally by a secure system, using a computer‐generated sequence, stratified by clinical site, with balance in respect of age (18 ‐ 49 or ≥ 50), sex (men or women), and BMI (≤ 28 or > 29) secured by minimisation".
Allocation concealment (selection bias) Low risk Quote: "Staff in the central trial office entered details of participants on the secure database, then notified participants and respective clinical sites of their allocation".
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "There was no subsequent blinding".
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "There was no subsequent blinding".
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: An intention‐to‐treat analysis was performed.
Selective reporting (reporting bias) High risk Comment: Treatment‐related complications were not reported adequately.
Other bias Low risk Quote: "This study was funded by the NIHR Health Technology Assessment Programme (as part of project No 97/10/99)".