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 | ||||||
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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.