Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy

Liver Transplant Clinical Trial

Official title:

"Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study".

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504487
• Other study ID #: ILBS/LIVEDONORS/01
• Status: Completed
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: February 25, 2022

Study information

• Verified date: January 2022
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 25, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Other:
• Drain Removal
Abdominal drain placed during surgery removal

Locations

Country	Name	City	State
India	ILBS - Parthiban	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of drain removal using 3x3 rule - overall complications.	Comprehensive complication index (CCI) - clavin dindo classification	patient will be followed upto 3 months after surgery
Secondary	Post operative pain relief	using Visual analogue score	patient will be followed upto 3 months after surgery
Secondary	Bile leak	standard ISGLS definition - drain bilirubin measured in mg/dl.	patient will be followed upto 3 months after surgery
Secondary	Length of hospital stay	calculated from the day of admission to day of discharge, and based on the number of nights spent in hospital	patient will be followed upto 3 months after surgery
Secondary	Surgical Site Infection (SSI)	patient has at least one of the following: purulent drainage from the superficial incision.; organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)).; superficial incision that is deliberately opened by a surgeon, physician* or physician designee and culture or non-culture based testing of the superficial incision or subcutaneous tissue is not performed AND patient has at least one of the following signs or symptoms: localized pain or tenderness; localized swelling; erythema; or heat.; diagnosis of a superficial incisional SSI by a physician* or physician designee.	patient will be followed upto 3 months after surgery
Secondary	reintervention rate	defined as any additional abdominal intervention ( surgical or radiological) during the same hospital stay after the primary operation	patient will be followed upto 3 months after surgery
Secondary	readmission rate	90 day readmission rate - any hospital admission after the index admission.	patient will be followed upto 3 months after surgery

External Links

•   Criteria for drain removal following liver resection
•   Living Donor Liver Transplantation for Acute Liver Failure: Donor Safety and Recipient Outcome
•   Prospective Validation of Optimal Drain Management "The 3 × 3 Rule" after Liver Resection