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A randomized study comparing two Robotic Liver Donation Surgeries: With versus without preservation of a part of middle hepatic vein.

Robotic right donor hepatectomy with versus without partial middle hepatic vein: A Randomized Study - ROMAN trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105376
Enrollment
50
Registered
2026-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K742- Hepatic fibrosis with hepatic sclerosis

Interventions

Intervention1: nil: nil Intervention2: Taking pure right lobe grafts: Pure right lobe grafts may have more segmental veins as they are take early in transection at being of seg 5 vein Control Interven

Sponsors

Amrita Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult robotic donor hepatectomies at our centre.

Exclusion criteria

Exclusion criteria: A open donor hepatectomies performed during this study period will be excluded. These include (a)emergency donor hepactectomies (b)robotic slot not available or (c)patient nor willing for robotic (d)ABO incompatible grafts. (e) Combined liver, pancreas, small bowel transplantation. (f) Retransplantation.

Design outcomes

Primary

MeasureTime frame
Primary To compare the patency of Neo Middle Hepatic Vein of right lobe grafts with and without partial MHV retrieved robotically in the recipient at 2 weeks, 8weeks. Timepoint: 2 weeks, 8weeks.

Secondary

MeasureTime frame
Donor parameters 1.Transection time 2.Blood loss during the procedure. 3.Peak and mean lactate levels 4.Post operative liver function -Peak and mean levels of Serum Bilirubin, SGOT, SGPT, ALP,GGT&PTINR 5.Time taken for normalization of transaminases, INR 6.Post hepatectomy complications as per clavian dindo classification 7. Satava Classification 8.Graft steatosis using liver biopsy 9.Liver regeneration using plain CT volumetry done after 8 weeks. 10.Duration of ICU stay 11.Need for readmissionTimepoint: 2 weeks, 8weeks.;Recipient parameters 1.Blood loss. 2.Peak and mean lactate levels 3.Post operative liver function -Peak and mean levels of Serum Bilirubin, SGOT, SGPT, ALP,GGT&PTINR 4.Peak transaminitis 5. Time taken for normalization of transaminases,INR 6. Early graft dysfunction 7.Clavien dindo classification for severity of surgical complication 8.Satava Classification 9.Small for size graft syndrome 10.Primary non function of the graft ( (PNF) 11.Duration of ICU stay 12.Liver regeneration using CT volumetry done after 8 weeks. 13.Need for readmission 14.Mortality. Timepoint: 2 weeks, 8weeks.;During bench 1.Reconstructable veins during bench more than 4mm 2.Cold ischemia time (CIT) 3.Warm ischemia time (WIT)Timepoint: 2 weeks, 8 weeks

Countries

India

Contacts

Public ContactDr Aishwarya Pal

Amrita Institute of Medical Sciences

aishwaryapal88449@gmail.com9168418878

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026