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Laparoscopic fundoplication surgery versus medical management for gastro‐oesophageal reflux disease (GORD) in adults

Appendices

Appendix 1. CENTRAL search strategy

Date Run: 16 June 2015. Via OVID platform

106 trials

CENTRAL (Cochrane Central Register of Controlled Trials) (The Cochrane Library Issue 8 of 12, August 2014)

ID Search

#1 MeSH descriptor: [Esophagus] explode all trees

#2 (esophag* or oesophag*)

#3 MeSH descriptor: [Gastroesophageal Reflux] explode all trees

#4 gastroesophageal reflux

#5 gastro oesophageal reflux

#6 gord

#7 gerd

#8 MeSH descriptor: [Duodenogastric Reflux] explode all trees

#9 bile reflux

#10 acid reflux

#11 gastric acid secret*

#12 stomach acid secret*

#13 gastric eros*

#14 stomach eros*

#15 MeSH descriptor: [Heartburn] this term only

#16 heartburn

#17 indigestion

#18 MeSH descriptor: [Esophagitis] explode all trees

#19 esophagitis

#20 oesophagitis

#21 low* sphincter* pressur*

#22 MeSH descriptor: [Gastric Emptying] explode all trees

#23 MeSH descriptor: [Gastroparesis] explode all trees

#24 MeSH descriptor: [Gastritis] explode all trees

#25 gastr* empt* disorder*

#26 stomach empt* disorder*

#27 MeSH descriptor: [Dyspepsia] this term only

#28 dyspep*

#29 MeSH descriptor: [Eructation] this term only

#30 eructation

#31 regurgitat*

#32 MeSH descriptor: [Hernia, Hiatal] this term only

#33 {OR #1 ‐ #32}

#34 MeSH descriptor: [Proton Pump Inhibitors] 1 tree(s) exploded

#35 proton pump inhibitor*

#36 ppi

#37 omeprazole

#38 esomeprazole

#39 lansoprazole

#40 pantoprazole

#41 rabeprazole

#42 MeSH descriptor: [Histamine H2 Antagonists] explode all trees

#43 cimetidine

#44 famotidine

#45 nizatidine

#46 ranitidine

#47 burimamide

#48 {OR #34 ‐ #47}

#49 MeSH descriptor: [Fundoplication] this term only

#50 fundoplication*

#51 nissen or rossetti

#52 toupet or lind or watson or besley

#53 {OR #49 ‐ #52}

#54 #33 and #48 and #53

Appendix 2. MEDLINE search strategy

Date of Search: Ovid MEDLINE 16 June 2015

Database: Ovid MEDLINE(R) <1946 to 16 June 2015>

1. exp Esophagus/

2. (esophag$ or oesophag$).mp.

3. exp gastroesophageal reflux/

4. (gastroesophageal adj3 reflux).mp.

5. (gastro adj3 oesophageal adj3 reflux).mp.

6. (gastro adj3 esophageal adj3 reflux).mp.

7. (gerd or gord).mp.

8. exp Duodenogastric Reflux/

9. bile reflux.mp.

10. (acid adj3 reflux).mp.

11. (gastric adj3 acid adj3 secret$).mp.

12. (stomach adj3 acid adj3 secret$).mp.

13. (gastric adj3 eros$).mp.

14. (stomach adj3 eros$).mp.

15. Heartburn/

16. (heartburn or indigestion).mp.

17. exp Esophagitis/

18. (esophagitis or oesophagitis).mp.

19. (low$ adj6 sphincter$ adj3 pressur$).mp.

20. Gastric Emptying/

21. Gastroparesis/

22. exp Gastritis/

23. (gastr$ adj3 empt$ adj3 disorder$).mp.

24. (stomach adj3 empt$ adj3 disorder$).mp.

25. Dyspepsia/

26. dyspep$.mp.

27. Eructation/

28. eructation.mp.

29. regurgitat$.mp.

30. Hernia, Hiatal/

31. hernia$ hiat$.mp.

32. or/1 ‐31

33. exp Proton Pump Inhibitors/

34. (proton adj3 pump adj3 inhibitor$).mp.

35. ppi.mp.

36. omeprazole.mp.

37. esomeprazole.mp.

38. lansoprazole.mp.

39. pantoprazole.mp.

40. rabeprazole.mp.

41. exp proton pumps/ai [Antagonists & Inhibitors]

42. exp Histamine H2 Antagonists/

43. (histamine H2 adj3 antagonist$).mp.

44. H2RA$.mp.

45. cimetidine.mp.

46. famotidine.mp.

47. nizatidine.mp.

48. ranitidine.mp.

49. burimamide.mp.

50. or/33 ‐ 49

51. Fundoplication/

52. fundoplication$.mp.

53. (nissen or rossetti).mp.

54. (toupet or lind or watson or besley).mp.

55. 51 or 52 or 53 or 54

56. 32 and 50 and 55

57. randomized controlled trial.pt.

58. controlled clinical trial.pt.

59. randomized.ab.

60. randomly.ab.

61. placebo.ab.

62. drug therapy.fs.

63. trial.ab.

64. groups.ab.

65. or/57 ‐ 64

66. 56 and 65

Lines 57‐64 were modified from ​Box 6.4.c: Cochrane Highly Sensitive Search Strategy for identifying randomized trials in MEDLINE: sensitivity‐maximizing version (2008 revision); Ovid format in Higgins 2011a.

Appendix 3. EMBASE search strategy

Date run in Embase (OVID): 16 June 2015

Database: Embase Classic+Embase 1947 to 16 June 2015

1. exp esophagus/

2. (esophag$ or oesophag$).mp.

3. exp gastroesophageal reflux/

4. (gastroesophageal adj3 reflux).mp.

5. (gastro adj3 oesophageal adj3 reflux).mp.

6. (gastro adj3 esophageal adj3 reflux).mp.

7. (gerd or gord).mp.

8. exp duodenogastric reflux/

9. bile reflux.mp.

10. (acid adj3 reflux).mp.

11. (gastric adj3 acid adj3 secret$).mp.

12. (stomach adj3 acid adj3 secret$).mp.

13. (gastric adj3 eros$).mp.

14. (stomach adj3 eros$).mp.

15. heartburn/

16. (heartburn or indigestion).mp.

17. exp esophagitis/

18. (esophagitis or oesophagitis).mp.

19. (low$ adj6 sphincter$ adj3 pressur$).mp.

20. stomach emptying/

21. stomach paresis/

22. exp gastritis/

23. (gastr$ adj3 empt$ adj3 disorder$).mp.

24. (stomach adj3 empt$ adj3 disorder$).mp.

25. dyspepsia/

26. dyspep$.mp.

27. eructation/

28. eructation.mp.

29. regurgitat$.mp.

30. hiatus hernia/

31. hernia$ hiat$.mp.

32. or/1‐ 31

33. proton pump inhibitor/

34. (proton adj3 pump adj3 inhibitor$).mp.

35. ppi.mp.

36. omeprazole/

37. omeprazole.mp.

38. esomeprazole/

39. esomeprazole.mp.

40. lansoprazole/

41. lansoprazole.mp.

42. pantoprazole/

43. pantoprazole.mp.

44. rabeprazole/

45. rabeprazole.mp.

46. histamine H2 receptor antagonist/

47. (histamine H2 adj3 antagonist$).mp.

48. H2RA$.mp.

49. cimetidine/

50. cimetidine.mp.

51. famotidine/

52. famotidine.mp.

53. nizatidine/

54. nizatidine.mp.

55. ranitidine/

56. ranitidine.mp.

57. burimamide/

58. burimamide.mp.

59. or/33 ‐ 58

60. stomach fundoplication/

61. fundoplication$.mp.

62. (nissen or rossetti).mp.

63. (toupet or lind or watson or besley).mp.

64. 60 or 61 or 62 or 63

65. 32 and 59 and 64

66. crossover procedure/

67. double blind procedure/

68. randomized controlled trial/

69. single‐blind procedure/

70. random$.ab.

71. factorial$.ab.

72. crossover$.ab.

73. cross over$.ab.

74. cross‐over$.ab.

75. placebo$.ab.

76. (doubl$ adj blind$).ab.

77. (singl$ adj blind$).ab.

78. assign$.mp.

79. allocat$.ab.

80. volunteer$.ab.

81. or/66 ‐ 80

82. 65 and 81

Results: 199

Lines 66‐80 from sections 6.4.11.2 Search filters for identifying randomized trials in EMBASE and section 6.3.2.2 What is in The Cochrane Central Register of Controlled Trials (CENTRAL) from EMBASE? in Higgins 2011a.

Appendix 4. Previous search strategies

CENTRAL search strategy

#1 esophagus/
#2 (esophag* or oesophag*)
#3 exp gastroesophageal reflux/
#4 (gastroesophageal reflux)
#5 gastro oesophageal reflux
#6 gord
#7 gerd
#8 duodenogastric reflux/
#9 bile reflux/
#10 acid reflux
#11 gastric acid secret*
#12 stomach acid secret*
#13 gastric eros*
#14 (stomach eros*)
#15 heartburn/
#16 (heartburn or indigestion)
#17 esophagitis/
#18 esophagitis
#19 oesophagitis
#20 (low* sphincter* pressur*)
#21 les
#22 gastric emptying/
#23 gastroparesis/
#24 gastritis/
#25 gastr* empt* disorder*
#26 stomach empt* disorder
#27 dyspepsia/
#28 dyspep*
#29 eructation/
#30 eructat*
#31 regurgitat*
#32 Hiatal hernia
#33 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR ( # AND 20 ) OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32)
#34 proton pump/
#35 proton pump inhibitor*
#36 ppi
#37 Omeprazole/
#38 omeprazole
#39 esomeprazole
#40 lansoprazole
#41 pantoprazole
#42 rabeprazole
#43 Histamine H2 Antagonists/
#44 cimetidine
#45 Cimetidine/
#46 Famotidine
#47 Nizatidine
#48 Ranitidine
#49 (#34 OR #35 OR #36 OR #37 OR #38 OR #39 OR #40 OR #41 OR #42 OR #43 OR #44 OR #45 OR #46 OR #47 OR #48)
#50 Fundoplication/
#51 nissen or rossetti
#52 toupet or lind or watson or besley
#53 (partial* fundoplication*)
#54 (laparoscop* fundoplication*)
#55 (#50 OR #51 OR #52 OR #53 OR #54)
#56 (#33 AND #49 AND #55), from 2006 to 2009

EMBASE search strategy

  1. (random$ or placebo$).ti,ab.

  2. ((single$ or double$ or triple$ or treble$) and (blind$ or mask$)).ti,ab.

  3. controlled clinical trial$.ti,ab.

  4. RETRACTED ARTICLE/

  5. or/1‐4

  6. (animal$ not human$).sh,hw.

  7. 5 not 6

  8. exp esophagus/

  9. (esophag$ or oesophag$).tw.

  10. exp gastroesophageal reflux/

  11. (gastroesophageal adj3 reflux).tw.

  12. (gastro adj3 oesophageal adj3 reflux).tw.

  13. (gastro adj3 esophageal adj3 reflux).tw.

  14. gord.tw.

  15. gerd.tw.

  16. exp duodenogastric reflux/

  17. exp bile reflux/

  18. (acid adj3 reflux).tw.

  19. (gastric adj3 acid adj3 secret$).tw.

  20. (stomach adj3 acid secret$).tw.

  21. (gastric adj3 eros$).tw.

  22. (stomach adj3 eros$).tw.

  23. exp heartburn/

  24. (heartburn or indigestion).tw.

  25. exp esophagitis/

  26. esophagitis.tw.

  27. oesophagitis.tw.

  28. (low$ adj6 sphincter$ adj3 pressur$).tw.

  29. les.tw.

  30. exp gastric emptying/

  31. exp gastroparesis/

  32. exp gastritis/

  33. (gastr$ adj3 empt$ adj3 disorder$).tw.

  34. (stomach adj3 empt$ adj3 disorder).tw.

  35. exp dyspepsia/

  36. dyspep$.tw.

  37. exp eructation/

  38. eructat$.tw.

  39. regurgitat$.tw.

  40. Hernia, Hiatal/

  41. or/8‐40

  42. exp proton pump/

  43. esomeprazole.mp.

  44. (proton adj3 pump adj3 inhibitor$).tw.

  45. ppi.tw.

  46. exp Omeprazole/

  47. omeprazole.tw.

  48. lansoprazole.tw.

  49. pantoprazole.tw.

  50. rabeprazole.tw.

  51. exp Histamine H2 Antagonists/

  52. cimetidine.tw.

  53. exp Cimetidine/

  54. famotidine.tw. or exp Famotidine/

  55. nizatidine.tw. or exp Nizatidine/

  56. ranitidine.tw. or exp Ranitidine/

  57. or/42‐56

  58. exp Fundoplication/

  59. (nissen or rossetti).tw.

  60. (toupet or lind or watson or besley).tw.

  61. (partial$ adj5 fundoplication$).tw.

  62. (laparoscop$ adj5 fundoplication$).tw.

  63. or/58‐62

  64. 41 and 57 and 63

  65. 7 and 64

  66. limit 65 to yr="2006 ‐Current"

MEDLINE search strategy

  1. randomized controlled trial.pt.

  2. controlled clinical trial.pt.

  3. randomized.ab.

  4. placebo.ab.

  5. clinical trials as topic.sh.

  6. randomly.ab.

  7. trial.ti.

  8. or/1‐7

  9. (animals not (humans and animals)).sh.

  10. 8 not 9

  11. exp esophagus/

  12. (esophag$ or oesophag$).tw.

  13. exp gastroesophageal reflux/

  14. (gastroesophageal adj3 reflux).tw.

  15. (gastro adj3 oesophageal adj3 reflux).tw.

  16. (gastro adj3 esophageal adj3 reflux).tw.

  17. gord.tw.

  18. gerd.tw.

  19. exp duodenogastric reflux/

  20. exp bile reflux/

  21. (acid adj3 reflux).tw.

  22. (gastric adj3 acid adj3 secret$).tw.

  23. (stomach adj3 acid secret$).tw.

  24. (gastric adj3 eros$).tw.

  25. (stomach adj3 eros$).tw.

  26. exp heartburn/

  27. (heartburn or indigestion).tw.

  28. exp esophagitis/

  29. esophagitis.tw.

  30. oesophagitis.tw.

  31. (low$ adj6 sphincter$ adj3 pressur$).tw.

  32. les.tw.

  33. exp gastric emptying/

  34. exp gastroparesis/

  35. exp gastritis/

  36. (gastr$ adj3 empt$ adj3 disorder$).tw.

  37. (stomach adj3 empt$ adj3 disorder).tw.

  38. exp dyspepsia/

  39. dyspep$.tw.

  40. exp eructation/

  41. eructat$.tw.

  42. regurgitat$.tw.

  43. Hernia, Hiatal/

  44. or/11‐43

  45. exp proton pump/

  46. esomeprazole.mp.

  47. (proton adj3 pump adj3 inhibitor$).tw.

  48. ppi.tw.

  49. exp Omeprazole/

  50. omeprazole.tw.

  51. lansoprazole.tw.

  52. pantoprazole.tw.

  53. rabeprazole.tw.

  54. exp Histamine H2 Antagonists/

  55. cimetidine.tw.

  56. exp Cimetidine/

  57. famotidine.tw. or exp Famotidine/

  58. nizatidine.tw. or exp Nizatidine/

  59. ranitidine.tw. or exp Ranitidine/

  60. or/45‐59

  61. exp Fundoplication/

  62. (nissen or rossetti).tw.

  63. (toupet or lind or watson or besley).tw.

  64. (partial$ adj5 fundoplication$).tw.

  65. (laparoscop$ adj5 fundoplication$).tw.

  66. or/61‐65

  67. 44 and 60 and 66

  68. 10 and 67

  69. limit 68 to yr="2006 ‐Current"

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figures and Tables -
Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figures and Tables -
Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 1 Health‐related quality of life (< 1 year).
Figures and Tables -
Analysis 1.1

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 1 Health‐related quality of life (< 1 year).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 2 Health‐related quality of life (1 to 5 years).
Figures and Tables -
Analysis 1.2

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 2 Health‐related quality of life (1 to 5 years).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 3 GORD‐specific quality of life (< 1 year).
Figures and Tables -
Analysis 1.3

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 3 GORD‐specific quality of life (< 1 year).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 4 GORD‐specific quality of life (1 to 5 years).
Figures and Tables -
Analysis 1.4

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 4 GORD‐specific quality of life (1 to 5 years).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 5 Serious adverse events.
Figures and Tables -
Analysis 1.5

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 5 Serious adverse events.

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 6 Adverse events.
Figures and Tables -
Analysis 1.6

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 6 Adverse events.

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 7 Dysphagia (< 1 year).
Figures and Tables -
Analysis 1.7

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 7 Dysphagia (< 1 year).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 8 Dysphagia (1 to 5 years).
Figures and Tables -
Analysis 1.8

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 8 Dysphagia (1 to 5 years).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 9 Dysphagia (5 years or more).
Figures and Tables -
Analysis 1.9

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 9 Dysphagia (5 years or more).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 10 Heartburn (< 1 year).
Figures and Tables -
Analysis 1.10

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 10 Heartburn (< 1 year).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 11 Heartburn (1 to 5 years).
Figures and Tables -
Analysis 1.11

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 11 Heartburn (1 to 5 years).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 12 Heartburn (5 years or more).
Figures and Tables -
Analysis 1.12

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 12 Heartburn (5 years or more).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 13 Reflux (< 1 year).
Figures and Tables -
Analysis 1.13

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 13 Reflux (< 1 year).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 14 Reflux (1 to 5 years).
Figures and Tables -
Analysis 1.14

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 14 Reflux (1 to 5 years).

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 15 Reflux (5 years or more).
Figures and Tables -
Analysis 1.15

Comparison 1 Laparoscopic fundoplication versus medical management, Outcome 15 Reflux (5 years or more).

Summary of findings for the main comparison. Laparoscopic fundoplication versus medical management for gastro‐oesophageal reflux disease (GORD) in adults

Laparoscopic fundoplication versus medical management for gastro‐oesophageal reflux disease (GORD) in adults

Patient or population: Patients with gastro‐oesophageal reflux disease (GORD) in adults
Settings: Secondary care
Intervention: Laparoscopic fundoplication

Control: Medical management

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Medical management

Laparoscopic fundoplication

Health‐related quality of life

(< 1 year)

The mean health‐related quality of life (< 1 year) in the intervention groups was
0.14 standard deviations higher
(0.02 lower to 0.3 higher)

605
(3 studies)

⊕⊝⊝⊝
very low1,2,3

SMD 0.14 (‐0.02 to 0.3)

(1 to 5 years)

The mean health‐related quality of life (1 to 5 years) in the intervention groups was
0.03 standard deviations higher
(0.19 lower to 0.24 higher)

323
(2 studies)

⊕⊝⊝⊝
very low1,2,4

SMD 0.03 (‐0.19 to 0.24)

GORD‐specific quality of life

(< 1 year)

The mean GORD‐specific quality of life (< 1 year) in the intervention groups was
0.58 standard deviations higher
(0.46 to 0.7 higher)

1160
(4 studies)

⊕⊕⊝⊝
low1

SMD 0.58 (0.46 to 0.7)

(1 to 5 years)

The mean GORD‐specific quality of life (1 to 5 years) in the intervention groups was
0.28 standard deviations higher
(0.27 lower to 0.84 higher)

994
(3 studies)

⊕⊝⊝⊝
very low1,2,3

SMD 0.28 (‐0.27 to 0.84)

Adverse events

Serious adverse events

124 per 1000

181 per 1000
(125 to 262)

RR 1.46
(1.01 to 2.11)

637
(2 studies)

⊕⊝⊝⊝
very low1,5

Adverse events

10 per 1000

140 per 1000
(8 to 1000)

RR 13.98
(0.82 to 237.07)

83
(1 study)

⊕⊝⊝⊝
very low1,3,5,6

Dysphagia

(< 1 year)

36 per 1000

129 per 1000
(69 to 241)

RR 3.58
(1.91 to 6.71)

637
(2 studies)

⊕⊝⊝⊝
very low1,6

(1 to 5 years)

19 per 1000

101 per 1000
(39 to 256)

RR 5.36
(2.1 to 13.64)

554
(1 study)

⊕⊝⊝⊝
very low1,6

(5 years or more)

255 per 1000

229 per 1000
(145 to 361)

RR 0.9
(0.57 to 1.42)

228
(1 study)

⊕⊝⊝⊝
very low1,3,6

Heartburn

(< 1 year)

222 per 1000

100 per 1000
(67 to 153)

RR 0.45
(0.3 to 0.69)

554
(1 study)

⊕⊝⊝⊝
very low1,6

(1 to 5 years)

222 per 1000

42 per 1000
(22 to 75)

RR 0.19
(0.1 to 0.34)

554
(1 study)

⊕⊝⊝⊝
very low1,6

(5 years or more)

736 per 1000

412 per 1000
(324 to 530)

RR 0.56
(0.44 to 0.72)

217
(1 study)

⊕⊝⊝⊝
very low1,6

Reflux

(< 1 year)

199 per 1000

20 per 1000
(10 to 48)

RR 0.1
(0.05 to 0.24)

554
(1 study)

⊕⊝⊝⊝
very low1,6

(1 to 5 years)

139 per 1000

21 per 1000
(8 to 49)

RR 0.15
(0.06 to 0.35)

554
(1 study)

⊕⊝⊝⊝
very low1,6

(5 years or more)

357 per 1000

246 per 1000
(164 to 367)

RR 0.69
(0.46 to 1.03)

233
(1 study)

⊕⊝⊝⊝
very low1,3,6

Long‐term overall health‐related quality of life and long‐term GORD‐specific quality of life were not reported in any of the trials.

*The basis for the assumed risk was the mean control group risk across studies for all outcomes other than adverse events. For control group risk, 1% was used as the control group risk since there were no adverse events in the control group in the only trial that reported this outcome (Anvari 2011). The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 The trial(s) was/were at high risk of bias.
2 There was substantial heterogeneity.
3 The confidence intervals overlapped no effect and 25% or more increase or 25% or more decrease or both.
4 There were fewer than 400 participants in both groups.
5 Some trials did not report this outcome although this can be expected to be reported in a randomised controlled trial of laparoscopic fundoplication versus medical treatment.
6 There were fewer than 300 events in total in both groups.

Figures and Tables -
Summary of findings for the main comparison. Laparoscopic fundoplication versus medical management for gastro‐oesophageal reflux disease (GORD) in adults
Comparison 1. Laparoscopic fundoplication versus medical management

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Health‐related quality of life (< 1 year) Show forest plot

3

605

Std. Mean Difference (IV, Fixed, 95% CI)

0.14 [‐0.02, 0.30]

2 Health‐related quality of life (1 to 5 years) Show forest plot

2

323

Std. Mean Difference (IV, Fixed, 95% CI)

0.03 [‐0.19, 0.24]

3 GORD‐specific quality of life (< 1 year) Show forest plot

4

1160

Std. Mean Difference (IV, Fixed, 95% CI)

0.58 [0.46, 0.70]

4 GORD‐specific quality of life (1 to 5 years) Show forest plot

3

994

Std. Mean Difference (IV, Random, 95% CI)

0.28 [‐0.27, 0.84]

5 Serious adverse events Show forest plot

2

637

Risk Ratio (M‐H, Fixed, 95% CI)

1.46 [1.01, 2.11]

6 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

7 Dysphagia (< 1 year) Show forest plot

2

637

Risk Ratio (M‐H, Fixed, 95% CI)

3.58 [1.91, 6.71]

8 Dysphagia (1 to 5 years) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

9 Dysphagia (5 years or more) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

10 Heartburn (< 1 year) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

11 Heartburn (1 to 5 years) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

12 Heartburn (5 years or more) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

13 Reflux (< 1 year) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

14 Reflux (1 to 5 years) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

15 Reflux (5 years or more) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figures and Tables -
Comparison 1. Laparoscopic fundoplication versus medical management