Evidence Table 6. Cohorts (non-comparative) studies on surgical interventions

Author, YrIntervention Enrolled/FinalPatient characteristicsFollow up /duration (yr)Status at follow up (P-value compared to preoperative values)Quality
Study designPopulation and study characteristics% ≥ grade 3 esophagitispH statusEMS /hiatal herniaResponded to PPI or H2RAChange in symptomsEsophagitis statuspH statusOff PPI/ Off all anti-secretory meds↓ PPI dose or now responds to dose that failed before RxQOL/ satisfactionEMS/Others
Anvari, 2001Laparoscopic Nissen FundoplicationNDMean acid reflux (%)8.43±0.53Lower esophageal sphincter: abnormal 7.16±0.3336%5Improved GERD symptom scoreNDReduced88%NDSatisfaction: 86%Lower esophageal sphincter: normal range P<0.001B
Prospective CohortEnrol/Final: 332/ 181abnormalHiatal hernia: NDP<0.0001P<0.0001Re-surgery Acceptance: 89%Tightness of wrap varied with pre-op Lower esophageal sphincter
Age: 46.5±14.1
Gender: Male 38%
Country: Canada
Setting: University Hospital
Booth, 2002Laparoscopic Nissen Fundoplication20% (> grade 2)5% abnormalNDND8Heart Burn: Improved 93%NDND86%NDSatisfaction: 91%NDC
Prospective CohortEnrol/Final: 179/48Regurg: Improved 91%
Age: 41 median (9–82)
Gender: Male 66%
Country: UK
Setting: Hospital
Lafullarde, 2001Laparoscopic Nissen FundoplicationNDNDNDND6No reflux symptoms: 87%NDND89%NDHigh mean score for satisfactionNDC
Prospective CohortEnrol/Final: 178/176Re-surgery acceptance: 90%
Age: nd
Gender: nd
Country: Australia
Setting: University Hospital
Bammer, 2001Laparoscopic Nissen FundoplicationNDMean score abnormalMean score abnormalND6.4Heartburn: 5.8%NDND86%NDOverall well being score improved P <0.000112.7% had barretts before surgery and none reported development of dysplasia/adenocarcinomaC
Retrospective CohortEnrol/Final: 171/171Regurg: Improved 93.6%Satisfaction: 93%
Age: 52±14
Gender: Male 63%
Country: US
Setting: Hospital
Granderath, 2002Laparoscopic Toupet Fundoplication33.6%100% abnormalLower esophageal sphincter: abnormal 100%0%5Heartburn: Improved 97.4%ND4.50%97.40%NDImproved to normative healthy dataNDC
11918872Enrol/Final: 155/39Regurg: Improved 96.7%
Prospective CohortAge: 50.2 (29–74)
Gender: Male 59%
Country: Austria
Setting: University hospital
Kamolz, 2002Laparoscopic antireflux procedures (excluded redo-surgery)NDAbnormal mean DeMeester score 100%ND0%5NDNDNDNDNDMean score comparable to healthy (NA compared to PPI at 5 yr)NDC
UIEnrol/Final: 511/107Difference sig compared to untreated patients
12236479Age: 47.6 (28–79)
Gender: 55%
Country: Spain
Setting: University hospital
Franzen, 1999Posterior Partial Fundoplication25%70% abnormal99% abnormalND10Clinically improved 92%ND24% pathological reflux94%NDNDND
Prospective CohortEnrol/Final: 101/87100% on meds for 6 mo11% had dysphagia compared to 66% preop
Age: ~57(70 yrs; 53; 53; 63) grade1–4 esophagitis2% new dysphagia
Gender: Male 52%Useful surgical procedure except in severe esophagitis
Country: Sweden
Setting: University Hospital
Henderson, 1985Open Total Nissen Fundoplication51%91.9% + ve statusLower esophageal sphincter: abnormal 46.2%ND6.593.1% excellent resultsNDNDNDNDNDNDC
Prospective CohortEnrol/Final: 351/335Hiatal hernia: 68.9%
Age: 45.5 (17–75)
Gender: 35%
Country: Canada
Setting: University hospital
Grande, 1994Open Total Nissen Fundoplication32%NDND0%2085% grade 1 and 2 scoreNDND85% of medsND89% satisfied and willing for re-surgery92% success rate in controlling symptoms over the 20yr period from actuarial analysisB
Prospective CohortEnrol/Final: 160/157(not taken into account for surgery)(not taken into account for surgery)
Age: 53±4
Gender: 55%
Country: Spain
Setting: University hospital
Luostarinen, 1993Open Total Nissen Fundoplication69%NDNDND~670%NDpH status 71% improvedNDNDNDNDC
Enrol/Final: 127/72
Age: 48 (22–74)
Gender: 57% men
Country: Finland
Setting: University hospital

From: Appendix C, Evidence Tables

Cover of Comparative Effectiveness of Management Strategies For Gastroesophageal Reflux Disease
Comparative Effectiveness of Management Strategies For Gastroesophageal Reflux Disease [Internet].
Comparative Effectiveness Reviews, No. 1.
Ip S, Bonis P, Tatsioni A, et al.

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