Table 2.
Participants randomised to treatment | Participants with preferred treatment | Total cohort | ||||
---|---|---|---|---|---|---|
Surgical (n=178) | Medical (n=179) | Surgical (n=261) | Medical (n=192) | |||
Fundoplication within 1 year of enrolment | 111 (62.4) | 10 (5.6) | 218 (83.5) | 3 (1.6) | ||
Fundoplication at any time during 5 year follow-up | 112 (62.9) | 24 (13.4) | 222 (85.1) | 6 (3.1) | ||
Reflux related re-operation: | 5 (4.5) | 1 (4.2) | 8* (4.5) | 2 (33.3) | 16 (4.4) | |
Reconstruction of same wrap | 2 | 1 | 2 | 1 | 6 | |
Conversion of type of wrap | 2 | 0 | 4 | 0 | 6 | |
Reversal of fundoplication | 0 | 0 | 1 | 1 | 2 | |
Repair of hiatus hernia only | 1 | 0 | 3 | 0 | 4 | |
Late postoperative complication†: | 2 (1.8) | 0 | 8 (3.6) | 2 (33.3) | 12 (3.3) | |
Oesophageal dilatation or stricture dilatation | 1 | 0 | 3 | 0 | 4 | |
Repair of incisional hernia | 0 | 0 | 3 | 0 | 3 | |
Other | 1‡ | 0 | 2§ | 2¶ | 5 |
*Two of the eight also had a third reflux related operation.
†Complication ≥1 month after operation.
‡Pain due to original wrap shifting.
§Admission for venous thromboembolism; pain from operation.
¶Hole between stomach and liver; bleed in stomach and/or bowel.