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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drain | No Intervention | Patients in the drain arm will undergo routine steps in donor hepatectomy. After graft removal, hemostasis and biliostasis will be confirmed, following which at the end of the operation ,a 28 Fr abdominal drain will be inserted with tip near cut surface of remnant | |
| No Drain | Experimental | 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. No intraabdominal drain will be placed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Drain i.e. Omission of abdominal drain placement | Other | Omission of abdominal drain placement in intervention arm. The No-drain arm will be compared to drain arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| CCI index on 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. | Admission one day prior to live donor hepatectomy till post operative day 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Infective complications | Surgical site infections, intra abdominal abscesses | Admission one day prior to live donor hepatectomy till post operative day 7 |
| Duration of hospital stay | Total days of hospitalization required from admission till post operative day 7 |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bharat Nair, MCh | Contact | 08373926785 | bharatarcher1@gmail.com | |
| Priyanka Tripathi | Contact | 9873440277 | Priyanka.Tripathi@marengoasia.com |
| Name | Affiliation | Role |
|---|---|---|
| Punit Singla, MS,DNB | Marengo Asia Hospitals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marengo Asia Hospitals | Recruiting | Faridabad | Haryana | 121002 | India |
Name or address in the study data will be coded with initials and number . The confidentiality will be maintained. Unless required by law, only the Study Doctor, the Study Team and its authorized agents and the Ethics Committee/Institution Review Board will have access to confidential data which identifies patients by name or has access to the in patient records of the patient
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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.
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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.
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| Admission one day prior to live donor hepatectomy till post operative day 7 |
| Paralytic ileus | Days to start normal oral diet after surgery | Admission one day prior to live donor hepatectomy till post operative day 7. |
| Bile leak | Occurrence and detection of bile leak after donor hepatectomy | Admission one day prior to live donor hepatectomy till post operative day 7 |
| Hemorrhage | Occurrence and detection of bleeding after live donor hepatectomy | Admission one day prior to live donor hepatectomy till post operative day 7 |
| Post operative pain scores | Post operative pain as measured by twice daily (Visual Analogue Scale)VAS scores | Admission one day prior to live donor hepatectomy till post operative day 7 |