Donor HepatectomyNCT06769776
Drain vs No Drain After Live Donor Hepatectomy
A study testing No Drain i.e. Omission of abdominal drain placement in people with Donor Hepatectomy, run by Marengo Asia Hospitals at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Donor Hepatectomy
- What is being tested?
- No Drain i.e. Omission of abdominal drain placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 2 Aug 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Marengo Asia Hospitals
Faridabad, Haryana, 121002
Bharat Nair, MBBS, MS, MRCS, MCh, +91 8373926785, bharatarcher1@gmail.com
Priyanka Tripathi, +91 9873440277, priyanka.tripathi@marengoasia.com
About this study
Official title: Drain Versus No-Drain After Live Donor Hepatectomy- A Randomized Controlled, Pilot Study
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.
Read the 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.
- Conditions
- Donor Hepatectomy
- Being tested
- No Drain i.e. Omission of abdominal drain placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Drain i.e. Omission of abdominal drain placementOther
Omission of abdominal drain placement in intervention arm. The No-drain arm will be compared to drain arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Drain i.e. Omission of abdominal drain placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Admission one day prior to live donor hepatectomy till post operative day 7.
Secondary outcomes (6)
Infective complications
Surgical site infections, intra abdominal abscesses
Measured: 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
Measured: Admission one day prior to live donor hepatectomy till post operative day 7
Paralytic ileus
Days to start normal oral diet after surgery
Measured: Admission one day prior to live donor hepatectomy till post operative day 7.
Bile leak
Occurrence and detection of bile leak after donor hepatectomy
Measured: Admission one day prior to live donor hepatectomy till post operative day 7
Hemorrhage
Occurrence and detection of bleeding after live donor hepatectomy
Measured: 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
Measured: Admission one day prior to live donor hepatectomy till post operative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start2 Aug 2024
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donor HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marengo Asia Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bharat Nair, Marengo Asia Hospitals
- Investigators
- Punit Singla, MS,DNB, Study director, Marengo Asia Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769776
- Sponsor's protocol ID
- MAHF/AP/LTP-1/EC/2024/04
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drain Versus No-Drain After Live Donor Hepatectomy- A Randomized Controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT06769776
- Acronym / sponsor ID
- MAHF/AP/LTP-1/EC/2024/04
- Conditions
- Donor Hepatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Marengo Asia HospitalsUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: No Drain i.e. Omission of abdominal drain placementPatients 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Drain i.e. Omission of abdominal drain placementOmission of abdominal drain placement in intervention arm. The No-drain arm will be compared to drain arm | Other | No Drain |
Primary outcome
CCI index on post operative day 7
Time frame: 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.
6 secondary outcomes
Infective complications
Time frame: Admission one day prior to live donor hepatectomy till post operative day 7
Duration of hospital stay
Time frame: Admission one day prior to live donor hepatectomy till post operative day 7
Paralytic ileus
Time frame: Admission one day prior to live donor hepatectomy till post operative day 7.
Bile leak
Time frame: Admission one day prior to live donor hepatectomy till post operative day 7
Hemorrhage
Time frame: Admission one day prior to live donor hepatectomy till post operative day 7
Post operative pain scores
Time frame: Admission one day prior to live donor hepatectomy till post operative day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Punit Singla, MS,DNB study director
Marengo Asia Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Drain i.e. Omission of abdominal drain placement in people with Donor Hepatectomy, run by Marengo Asia Hospitals at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bharat Nair, MCh (08373926785, bharatarcher1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CCI index on post operative day 7 (time frame: Admission one day prior to live donor hepatectomy till post operative day 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.