Table 3.
Primary and secondary endpoints for participants allocated to laparoscopic cholecystectomy or percutaneous catheter drainage. Values are numbers (percentages) unless stated otherwise
| Outcomes | Cholecystectomy group (n=66) | Drainage group (n=68) | Risk ratio (95% CI) | P value |
|---|---|---|---|---|
| Primary endpoints* | ||||
| Death | 2 (3) | 6 (9) | 0.34 (0.07 to 1.64) | 0.27 |
| Major complications† | 8 (12) | 44 (65) | 0.19 (0.10 to 0.37) | <0.001 |
| Secondary endpoints* | ||||
| Death: | 2 (3) | 6 (9) | 0.34 (0.07 to 1.64) | 0.27 |
| Directly/indirectly related to acute cholecystitis | 0 | 3 (4) | ||
| Unrelated to acute cholecystitis | 2 (3) | 2 (3) | ||
| Unknown cause | 0 | 1 (2) | ||
| Infectious and cardiopulmonary complication‡: | 5 (8) | 3 (4) | 0.97 (0.89 to 1.05) | 0.49 |
| Intra-abdominal abscess | 4 (6) | 2 (3) | ||
| Pneumonia | 2 (3) | 1 (2) | ||
| Myocardial infarction | 0 | 0 | ||
| Pulmonary embolism | 0 | 0 | ||
| Need for reintervention‡: | 8 (12) | 45 (66) | 0.18 (0.09 to 0.36) | <0.001 |
| Surgical intervention | 3 (5) | 32 (47) | 0.10 (0.03 to 0.30) | <0.001 |
| Emergency cholecystectomy | NA | 11 (16) | ||
| Clinical deterioration | NA | 2 (3) | ||
| Recurrent cholecystitis | NA | 9 (13) | ||
| Elective cholecystectomy§ | 2 (2) | 20 (29) | ||
| Recurrent gallstone related disease | NA | 15 (22) | ||
| Dysfunctional drain¶ | NA | 1 (2) | ||
| Absence of duodenal backflow revealed by cholangiography¶ | NA | 4 (6) | ||
| Cholecystectomy not performed during index admission¶ | 2 (2) | NA | ||
| Diagnostic laparoscopy | 1 (2) | 1 (2) | ||
| Endoscopic intervention | 6 (9) | 11 (16) | 0.56 (0.22 to 1.43) | 0.22 |
| ERCP | 6 (9) | 11 (16) | ||
| Choledocholithiasis | 2 (3) | 9 (13) | ||
| Biliary injury | 4 (6) | 2 (3) | ||
| Removal of biliary stent | 1 (2) | 0 | ||
| Radiological intervention | 4 (6) | 15 (22) | 0.28 (0.10 to 0.79) | 0.008 |
| Percutaneous catheter drainage | NA | 8 (12) | ||
| Recurrent cholecystitis | NA | 6 (9) | ||
| Dysfunctional drain | NA | 2 (3) | ||
| Drainage abscess | 3 (5) | 4 (6) | ||
| Drainage biloma | 2 (3) | 0 | ||
| Drainage ascites | 0 | 1 (2) | ||
| Antegrade cholangiography | NA | 4 (6) | ||
| Contrast image PTC tube | 1 (2) | 0 | ||
| Recurrent biliary disease‡: | 3 (5) | 36 (53) | 0.09 (0.03 to 0.27) | <0.001 |
| Requiring emergency readmission | 3 (5) | 28 (41) | ||
| Requiring planned readmission | 2 (3) | 16 (24) | ||
| Elective cholecystectomy | NA | 15 (22) | ||
| ERCP | 2 (3) | 3 (4) | ||
| Minor complication: | 0 | 4 (6) | 0.12 | |
| Wound infection | 0 | 2 (3) | ||
| Bleeding | 0 | 0 | ||
| Urinary tract infection | 0 | 2 (3) | ||
| Healthcare utilisation: | ||||
| Median (interquartile range) length of stay after randomisation (days) | 4 (3-6) | 6 (4-8) | 0.01 | |
| Median (interquartile range) total length of hospital stay (days) | 5 (4-8) | 9 (6-19) | <0.001 | |
| Median (interquartile range) total length of stay in ICU (days) | 0 (0-0) | 0 (0-0) | 0.16 | |
| Total No (range per patient) of ER visits per study group | 7 (0-1) | 56 (0-5) | <0.001 | |
| Total No (range per patient) of reinterventions per study group | 21 (0-6) | 64 (0-4) | <0.001 | |
| Total No (range per patient) of readmissions per study group | 9 (0-2) | 67 (0-5) | <0.001 | |
ERCP=endoscopic retrograde cholangiopancreatography; PTC=percutaneous transhepatic cholangiography; ICU=intensive care unit; ER=emergency department; NA=not applicable.
Multiple events in same patient were considered as one endpoint.
For example, infectious and cardiopulmonary complications within one month, need for reintervention within one year, or recurrent biliary disease within one year.
Included in primary endpoint of major complications.
Elective cholecystectomies were not included in primary endpoint, unless performed for recurrent gallstone related disease.
These procedures were not included in primary endpoint because the adjudication committee judged the indication debatable.