Healthy Donors for Liver TransplantationNCT02413983
Comparison of Postoperative Outcome of Hepatectomy for Living Donors According to Three Different Incision
An observational study of Healthy Donors for Liver Transplantation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Living donor liver transplantation (LDLT) is an important option for patients with end-stage liver disease requiring liver transplantation. When performing LDLT, the safety and well being of donors is of the utmost importance. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Donors for Liver Transplantation
- What is being tested?
- hepatectomy conventional incision, hepatectomy midline incision and hepatectomy transverse incision
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study was a single center, non-randomized, observational comparative analysis of 3 different surgical technique. The living liver donors underwent hepatectomy using three different type of incisions; 1) right subcostal incision with a midline extension 2) upper midline incision without laparoscopic assistance 3) transverse incision with laparosocpic assistance
Who may be able to join
- ASA (American Society of Anesthesiologists) physical status I-II,
- adult undergoing hepatectomy for living donors
Who cannot join
- known allergy to any of the drugs used in this study,
- bleeding diathesis,
- neurologic dysfunction (preexisting lower limb neurological deficit),
- recent systemic or local infections,
- history of drug use, or
- under treatment with opioids because of chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Outcome of Hepatectomy for Living Donors According to Three Different Incision: Conventional Incision vs Minimal Incision vs Transverse Incision Assisted by Laparoscopy
Living donor liver transplantation (LDLT) is an important option for patients with end-stage liver disease requiring liver transplantation. When performing LDLT, the safety and well being of donors is of the utmost importance. The conventional incision for donor hepatectomy is a right subcostal incision with a midline extension up to xiphoid. Minimally invasive liver surgery throughout a single 10 cm upper midline incision without laparoscopic assistance has been widely applied and considered to be safe and effective. Recently, laparoscopic and minimally invasive living donor hepatectomy via transverse incision has been suggested to reduce morbidity and the invasiveness of living donor hepatectomy. Although minimally invasive approach has become the surgical method of choice for many transplant centers, little data on comparing the impact of all three different type incision in living liver donors. In our center, the investigators have adopted three different incision according to surgical teams. The investigators undertook this study with the aims of comparing the pain and quality of life of donors according to type of three different incisions and assessing any benefits to the donor due to the smaller midline incision during the early postoperative period.
- Conditions
- Healthy Donors for Liver Transplantation
- Being tested
- hepatectomy conventional incision, hepatectomy midline incision, hepatectomy transverse incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatectomy conventional incisionProcedure or surgery
This study was a single center, nonrandomized, observational comparative analysis of 3 different surgical technique. Three surgical teams operated alternately at our center, and donors undergoing hepatectomy via three different incision
hepatectomy midline incisionProcedure or surgery
hepatectomy transverse incisionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CI (conventional incision) | The living liver donors underwent hepatectomy using right subcostal incision with a midline extension (conventional incision) Receives: Procedure: hepatectomy conventional incision | |
| MI (midline incision) | The living liver donors underwent hepatectomy using upper midline incision (10cm) without laparoscopic assistance Receives: Procedure: hepatectomy midline incision | |
| TI (transverse incision) | The living liver donors underwent hepatectomy using transverse incision with laparosocpic assistance Receives: Procedure: hepatectomy transverse incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)
QoR (quality of recovery) -15, has recently been developed, which can provide an extensive yet efficient evaluation of postoperative recovery from the patient's perspective [8]. The QoR-15 is an abbreviation of the longer and more comprehensive QoR-40 [15], and includes questions on pain, physical comfort, physical independence, psychological support and emotional state, and can be completed in approximately 2 minutes.
Measured: postoperative 7 day
Secondary outcomes (6)
consumption of analgesics on postoperative day
Measured: 1, 4, 8, 24, 48 and 72 h after surgery
discomfort related to the scar
abdominal wall sensorineural deficits (numbness and differences in tactile and temperature sensations) and tightness around the scar
Measured: postoperative 7 day
discomfort related to the scar
abdominal wall sensorineural deficits (numbness and differences in tactile and temperature sensations) and tightness around the scar
Measured: postoperative 30 day
side effects (nausea, vomiting, back pain, pruritus)
nausea, vomiting, back pain, pruritus
Measured: 1, 4, 8, 24, 48 and 72 h after surgery
donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)
QoR (quality of recovery) -15, has recently been developed, which can provide an extensive yet efficient evaluation of postoperative recovery from the patient's perspective [8]. The QoR-15 is an abbreviation of the longer and more comprehensive QoR-40 [15], and includes questions on pain, physical comfort, physical independence, psychological support and emotional state, and can be completed in approximately 2 minutes.
Measured: postoperative 30 day
assessment of subjective pain (as measured by numeric rating scale [NRS]) on postoperative day
numeric rating scale (NRS) in which; 0 = no pain and 100 = worst pain
Measured: 1, 4, 8, 24, 48 and 72 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2017
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Donors for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaab Soo Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413983
- Sponsor's protocol ID
- 2015-01-016-002
- Status last verified
- Jul 2019
- First submitted
- 2 Apr 2015
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Outcome of Hepatectomy for Living Donors According to Three Different Incision: Conventional Incision vs Minimal Incision vs Transverse Incision Assisted by Laparoscopy
- ClinicalTrials.gov ID
- NCT02413983
- Acronym / sponsor ID
- 2015-01-016-002
- Conditions
- Healthy Donors for Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 10 Apr 2015 (estimated)
- 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.
Living donor liver transplantation (LDLT) is an important option for patients with end-stage liver disease requiring liver transplantation. When performing LDLT, the safety and well being of donors is of the utmost importance. The conventional incision for donor hepatectomy is a right subcostal incision with a midline extension up to xiphoid. Minimally invasive liver surgery throughout a single 10 cm upper midline incision without laparoscopic assistance has been widely applied and considered to be safe and effective. Recently, laparoscopic and minimally invasive living donor hepatectomy via transverse incision has been suggested to reduce morbidity and the invasiveness of living donor hepatectomy. Although minimally invasive approach has become the surgical method of choice for many transplant centers, little data on comparing the impact of all three different type incision in living liver donors. In our center, the investigators have adopted three different incision according to surgical teams. The investigators undertook this study with the aims of comparing the pain and quality of life of donors according to type of three different incisions and assessing any benefits to the donor due to the smaller midline incision during the early postoperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CI (conventional incision) | – | Procedure: hepatectomy conventional incisionThe living liver donors underwent hepatectomy using right subcostal incision with a midline extension (conventional incision) |
| MI (midline incision) | – | Procedure: hepatectomy midline incisionThe living liver donors underwent hepatectomy using upper midline incision (10cm) without laparoscopic assistance |
| TI (transverse incision) | – | Procedure: hepatectomy transverse incisionThe living liver donors underwent hepatectomy using transverse incision with laparosocpic assistance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study was a single center, non-randomized, observational comparative analysis of 3 different surgical technique. The living liver donors underwent hepatectomy using three different type of incisions; 1) right subcostal incision with a midline extension 2) upper midline incision without laparoscopic assistance 3) transverse incision with laparosocpic assistance
Key inclusion criteria (2 listed)
- ASA (American Society of Anesthesiologists) physical status I-II,
- adult undergoing hepatectomy for living donors
Key exclusion criteria (6 listed)
- known allergy to any of the drugs used in this study,
- bleeding diathesis,
- neurologic dysfunction (preexisting lower limb neurological deficit),
- recent systemic or local infections,
- history of drug use, or
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 |
|---|---|---|
| hepatectomy conventional incisionThis study was a single center, nonrandomized, observational comparative analysis of 3 different surgical technique. Three surgical teams operated alternately at our center, and donors undergoing hepatectomy via three different incision | Procedure or surgery | CI (conventional incision) |
| hepatectomy midline incision | Procedure or surgery | MI (midline incision) |
| hepatectomy transverse incision | Procedure or surgery | TI (transverse incision) |
Primary outcome
donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)
Time frame: postoperative 7 day
QoR (quality of recovery) -15, has recently been developed, which can provide an extensive yet efficient evaluation of postoperative recovery from the patient's perspective [8]. The QoR-15 is an abbreviation of the longer and more comprehensive QoR-40 [15], and includes questions on pain, physical comfort, physical independence, psychological support and emotional state, and can be completed in approximately 2 minutes.
6 secondary outcomes
consumption of analgesics on postoperative day
Time frame: 1, 4, 8, 24, 48 and 72 h after surgery
discomfort related to the scar
Time frame: postoperative 7 day
discomfort related to the scar
Time frame: postoperative 30 day
side effects (nausea, vomiting, back pain, pruritus)
Time frame: 1, 4, 8, 24, 48 and 72 h after surgery
donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)
Time frame: postoperative 30 day
assessment of subjective pain (as measured by numeric rating scale [NRS]) on postoperative day
Time frame: 1, 4, 8, 24, 48 and 72 h after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Donors for Liver Transplantation, run by Samsung Medical Center at 1 site in South Korea.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jul 2019. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
donor recovery/quality of life (as measure bye the quality of recovery [OoR] score) (time frame: postoperative 7 day). 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 25 Jul 2019.