Table 2.
Postoperative course in the modified intention-to-treat population.
| RPD n = 29 | OPD n = 33 | Difference with 95% CI | p value | |
|---|---|---|---|---|
| CCI (mean imputation)j | 34.02 ± 23.48 | 36.45 ± 27.65 | −2.42 [−15.55; 10.71] | 0.713 |
| Mortality within 90 daysa | 0 (0.0%) | 3 (9.1%) | ||
| QoR-15 | ||||
| Preoperativelyb | 117 ± 33 | 107 ± 29 | 10 [−10; 30] | 0.312 |
| POD4c | 82 ± 29 | 92 ± 30 | −10 [−27; 6] | 0.217 |
| Change from preoperatively to POD 4d | −32 ± 30 | −19 ± 27 | −13 [−33; 7] | 0.183 |
| Time to functional recovery (days)e,k | 17 ± 15 | 13 ± 8 | 4 [−2; 11] | 0.163 |
| Length of stay in the ICU (days)f,k | 0 (0–4) | 0 (0–0) | 0.099 | |
| Length of hospital stay (days)j | 17 (11–27) | 13 (9–19) | 0.177 | |
| Superficial SSI within 30 days | 3 (10.3%) | 3 (9.4%) | 1.0% [−14.0%; 16.0%] | 0.899 |
| Number of patients with a least one pancreas specific complication | 18 (62.1%) | 15 (45.5%) | 16.6% [−7.9%; 41.1%] | 0.191 |
| Number of patients with at least one major (grade B/C) pancreas-specific complication | 17 (58.6%) | 11 (33.3%) | 25.3% [1.2%; 49.4%] | 0.046 |
| POPF grade B/C | 11 (37.9%) | 7 (21.2%) | 16.7% [−5.8%; 39.2%] | 0.148 |
| Biliary leak grade B/C | 5 (17.2%) | 3 (9.1%) | 8.2% [−8.7%; 25.0%] | 0.339 |
| PPH grade B/C | 4 (13.8%) | 1 (3.0%) | 10.8% [−3.1%; 24.6%] | 0.120 |
| DGE grade B/C | 10 (34.4%) | 2 (6.0%) | 28.4% [9.3%; 47.5%] | 0.005 |
| Chyle leak grade B/C | 2 (6.9%) | 1 (3.0%) | 3.9% [−7.1%; 14.8%] | 0.479 |
| Number of patients with non-surgical reintervention | 15 (51.7%) | 10 (30.3%) | 21.4% [−2.6%; 45.4%] | 0.086 |
| Type of reintervention | ||||
| CT guided drain placement | 20 (50.0%) | 11 (44.0%) | ||
| Angiography (with/without stent/coiling) | 4 (10.0%) | 0 (0.0%) | ||
| Endoscopy | 0 (0.0%) | 1 (4.0%) | ||
| Other | 7 (21.2%) | 2 (8.0%) | ||
| Number of patients with re-operation(s) | 4 (13.8%) | 5 (15.2%) | −1.4% [−18.9%; 16.2%] | 0.880 |
| Number of patients with readmission(s) | 5 (17.2%) | 5 (16.1%) | 1.1% [−17.8%; 20%] | 0.908 |
| Pain at restj | ||||
| POD2g | 1.3 ± 0.9 | 1.3 ± 0.9 | 0 [−0.5; 0.5] | 0.919 |
| POD4h | 1.1 ± 0.9 | 1.1 ± 1.6 | 0 [−0.8; 0.8] | 0.926 |
| Pain at movementj | ||||
| POD2g | 2.9 ± 1.3 | 2.9 ± 1.4 | 0 [−0.8; 0.8] | 0.974 |
| POD4h | 2.4 ± 1.4 | 2.6 ± 1.6 | −0.2 [−1.2; 0.8] | 0.684 |
| Procedure-related costs (Euro)j | 4744 ± 1254 | 866 ± 459 | 3878 [3410; 4347] | <0.001 |
| Overall inpatient hospital costs (Euro)i,j | 33,502 ± 22,314 | 21,429 ± 12,427 | 12,073 [2932; 21,213] | 0.011 |
Values in parentheses are percentages unless indicated otherwise.
Values in parentheses are percentages unless indicated otherwise.
90-day mortality: patients lost to FU were censored and counted as no death.
QoR-15 score preoperatively: n = 9 missing in RPD and n = 13 missing in OPD group.
QoR-15 score POD 4: n = 4 missing in RPD and n = 8 missing in OPD group.
QoR-15 score Change from preoperatively to POD 4: n = 10 missing in RPD and n = 17 missing in OPD group.
Time to functional recovery including 26 RPD and 31 OPD patients who achieved functional recovery.
Including 12 patients in the RPD and 8 patients in the RPD group with ICU stay and the other patients with lengths of intensive care unit stay of 0 days.
Pain at rest and at movement at POD 2: n = 6 missing in RPD and n = 5 missing in OPD group.
Pain at rest: n = 9 and at movement n = 10 in RPD and n = 10 missing at rest and at movement in OPD group.
Overall in-hospital costs n = 1 missing in OPD group.
Values are mean ± SD; Differences with p values < 0.05 were deemed statistically significant and these p values are presented in bold; CCI: Charlson comorbidity index, QoR-15: Quality of Recovery-15 score, ICU: intensive care unit, SSI: surgical site infection, POPF: postoperative pancreas fistula, POD: postoperative day, NASA: National Aeronautics and Space Administration.
Values are median (interquartile range).