Donor Hepatectomy
Conditions
Brief summary
Prophylactic abdominal drain placement after donor hepatectomy has been a common or even mandatory practice in most transplant centers. This serves to monitor the occurrence of post-operative intra-abdominal bleeding and is used for the detection and drainage of any bile leakage. However prophylactic drain placement is not without complications, like; Increased rates of intraabdominal and wound infection, Increased abdominal pain, Decreased pulmonary function, Bowel injury and Prolonged hospital stay. Comprehensive Complication Index (CCI) is a valuable tool used to assess the overall morbidity of patients after surgical interventions . The CCI score ranges from 0 (no complication) to 100 (death), reflecting the gravity of the overall complication burden on the patient on a continuous scale and is a validated tool for living donor liver transplants. The investigators aim to compare the safety of no drain placement vs abdominal drain placement in LDLT(Live Donor Liver Transplant) by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy.
Detailed description
* This study will be a randomised controlled, pilot study to compare the safety of no drain placement vs abdominal drain placement in LDLT by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy. * Patient admitted for donor hepatectomy will be recruited and further randomised into the Drain and No-Drain arms. Patients in the no drain arm will undergo routine steps in donor hepatectomy. After graft removal, hemostasis and biliostasis will be confirmed, following which abdomen will be closed in layers. For patients in the drain arm, same steps will be followed. At the end of the operation , additionally, 28 Fr abdominal drain will be inserted with tip near cut surface of remnant. Intraoperative and post-operative parameters will be compared between the groups. Comprehensive Complication index will be calculated on day of discharge using online universal CCI calculator application.
Interventions
OTHERNo Drain i.e. Omission of abdominal drain placement
Omission of abdominal drain placement in intervention arm. The No-drain arm will be compared to drain arm
Sponsors
Marengo Asia Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Trial will commence as soon as clearance from ethics committee is achieved. All voluntary healthy liver donors planned for donor hepatectomy, fulfilling inclusion criteria and not matching any of the exclusion criteria will be recruited . On the day of surgery, donor will be alloted either of the arms based on computer generated block randomization code.
Intervention model description
The investigators aim to compare the safety of no drain placement vs abdominal drain placement in LDLT by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Patients undergoing donor hepatectomy -
Exclusion criteria
Any patient not consenting to the procedure. Intraoperative need for drain placement in no drain arm due to surgical factors. Inverted L/ J shaped incision. Laparoscopic donor hepatectomy Robotic donor hepatectomy. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CCI index on post operative day 7 | Admission one day prior to live donor hepatectomy till post operative day 7. | Comprehensive Complication Index (CCI) is a valuable tool used to assess the overall morbidity of patients after surgical interventions . The CCI score ranges from 0 (no complication) to 100 (death), reflecting the gravity of the overall complication burden on the patient on a continuous scale and is a validated tool for living donor liver transplants. The investigators aim to compare the safety of no drain placement vs abdominal drain placement in LDLT by comparing the comprehensive complication index(CCI) between both arms on post operative day 7 after donor hepatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infective complications | Admission one day prior to live donor hepatectomy till post operative day 7 | Surgical site infections, intra abdominal abscesses |
| Duration of hospital stay | Admission one day prior to live donor hepatectomy till post operative day 7 | Total days of hospitalization required from admission till post operative day 7 |
| Paralytic ileus | Admission one day prior to live donor hepatectomy till post operative day 7. | Days to start normal oral diet after surgery |
| Bile leak | Admission one day prior to live donor hepatectomy till post operative day 7 | Occurrence and detection of bile leak after donor hepatectomy |
| Hemorrhage | Admission one day prior to live donor hepatectomy till post operative day 7 | Occurrence and detection of bleeding after live donor hepatectomy |
| Post operative pain scores | Admission one day prior to live donor hepatectomy till post operative day 7 | Post operative pain as measured by twice daily (Visual Analogue Scale)VAS scores |
Countries
India
Contacts
CONTACTBharat Nair, MCh
CONTACTPriyanka Tripathi
STUDY_DIRECTORPunit Singla, MS,DNB
Marengo Asia Hospitals
Outcome results
None listed