Clinical trial NCT04504487: Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy
Official title: "Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: It's a randomized control trial to compare early drain removal versus standard drain removal after donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate the safety of early drain removal using 3x3 rule with routine drain removal.

Detailed description: * Prophylactic abdominal drainage after donor right hepatectomy for LDLT has been a common or even mandatory practice in most transplant centres.
* This serves to monitor the occurrence of postoperative intraabdominal bleeding and is used for the detection and drainage of any bile leakage.
* Below table mentions both advantages and disadvantages of prophylactic drain placement after hepatectomy.

Advantages

1. Early detection of haemorrhage
2. Early detection of bile leak
3. Early reintervention Disadvantages

1. Increased rates of intraabdominal and wound infection, 2. Increased abdominal pain, 3. Decreased pulmonary function, 4. Prolonged hospital stay, 5. Bowel injury.

* Our study in ILBS for ALF donors, the overall complication rate was 20% as per Clavien-Dindo classification, of which a majority (15.9%) had grade 1 or 2 complications. Major complications (3b and above) were seen in 4 (1.0%) patients. Biliary complications were noted in 1.7% only.
* In a study by Japanese group concluded that 3 × 3 rule is clinically feasible and allows for the early removal of the drain tube with minimum infection risk after liver resection. The ''3 x 3 rule'': the drain will be removed when the drain fluid bilirubin concentration is \<3 mg/dl on day 3 after operation.
* In our institute we remove drain routinely, when output is less than 100ml and serous. That is usually on postoperative day 5-7.
* There is no randomized control trail done in donor hepatectomy comparing early versus standard drain removal.

Eligibility criteria: Inclusion Criteria:

* • Donors evaluated as per institutional protocol for donor hepatectomy and found fit

  * Those who consent

Exclusion Criteria:

* Patients refusing to consent for inclusion in the study.
* Left lateral hepatectomy.

Primary outcomes:
measure: safety of drain removal using 3x3 rule - overall complications.
timeFrame: patient will be followed upto 3 months after surgery
Secondary outcomes:
measure: Post operative pain relief
timeFrame: patient will be followed upto 3 months after surgery
measure: Bile leak
timeFrame: patient will be followed upto 3 months after surgery
measure: Length of hospital stay
timeFrame: patient will be followed upto 3 months after surgery
measure: Surgical Site Infection (SSI)
timeFrame: patient will be followed upto 3 months after surgery
measure: reintervention rate
timeFrame: patient will be followed upto 3 months after surgery
measure: readmission rate
timeFrame: patient will be followed upto 3 months after surgery
Other outcomes:
Locations:
city: Delhi
country: India
facility: ILBS - Parthiban
Study officials:
References: