Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy
NCT ID: NCT04504487
Last Updated: 2022-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2021-01-28
2022-02-25
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Early drain removal - POD3
Drain removal on POD3 if drain bilirubin is less than 3mg/dl and serous in nature.
Drain Removal
Abdominal drain placed during surgery removal
Routine Drain Removal
Drain removed routinely when the output is less than 100ml and serous in nature
Drain Removal
Abdominal drain placed during surgery removal
Interventions
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Drain Removal
Abdominal drain placed during surgery removal
Eligibility Criteria
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Inclusion Criteria
* Those who consent
Exclusion Criteria
* Left lateral hepatectomy.
ALL
Yes
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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ILBS - Parthiban
Delhi, , India
Countries
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References
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Durairaj P, Pamecha V, Mohapatra N, Patil NS, Sindwani G. Early drain removal after live liver donor hepatectomy is safe - a randomized controlled pilot study. Langenbecks Arch Surg. 2023 Sep 5;408(1):350. doi: 10.1007/s00423-023-03088-9.
Related Links
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Prospective Validation of Optimal Drain Management "The 3 × 3 Rule" after Liver Resection
Living Donor Liver Transplantation for Acute Liver Failure: Donor Safety and Recipient Outcome
Criteria for drain removal following liver resection
Other Identifiers
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ILBS/LIVEDONORS/01
Identifier Type: -
Identifier Source: org_study_id
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