Trial reportLangenbeck's archives of surgery2023
Early drain removal after live liver donor hepatectomy is safe - a randomized controlled pilot study.
Trial report in Langenbeck's archives of surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04504487 ("Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study".), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
"Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study".
Who cites it
0 citing papers in PubMed, 0 citations in OpenAlex.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe current study aimed to assess the safety of early drain removal after live donor hepatectomy (LDH).
methodsOne hundred eight consecutive donors who met the inclusion criteria were randomized to early drain removal (EDR - postoperative day (POD) 3 - if serous and the drain bilirubin level was less than 3 mg/dl - "3 × 3" rule) and routine drain removal (RDR - drain output serous and less than 100 ml). The primary outcome was to compare the safety. The secondary outcome was to compare the postoperative morbidity.
resultsPreoperative, intraoperative, and postoperative parameters except for the timing of drain removal were comparable. EDR was feasible in 46 out of 54 donors (85.14%) and none required re-intervention after EDR. There was significantly better pain relief with EDR (p = 0.00). Overall complications, pulmonary complications, and hospital stay were comparable on intention-to-treat analysis. However, pulmonary complications (EDR - 1.9% vs RDR - 16.3% P = 0.030), overall complications (18.8% vs 36.3%, P = 0.043), and hospital stay (8 vs 9, P = 0.014) were more in the RDR group on per treatment analysis. Bile leaks were seen in three donors (3.7% in the EDR group vs 1.9% in RDR, P = 0.558), and none of them required endo-biliary interventions. Re-exploration for intestinal obstruction was required for 3 donors in RDR (0% vs 5.7%; p = 0.079).
conclusionEDR by the "3 × 3" rule after LDH is safe and associated with better pain relief. On per treatment analysis, EDR was associated with significantly less hospital stay and lower pulmonary and overall complications. CLINICAL TRIAL REGISTRY: Clinical Trials.gov - NCT04504487.
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