Kidney Transplantation, Living Donors, Nephrectomy, Surgery, Laparoscopic
Conditions
Brief summary
Laparoscopic nephrectomy (removal of the kidney) is the most common procedure for people donating a kidney to be used for living donor kidney transplantation. Laparoscopic donor nephrectomy (LDN) was a great advance in the field of living donor kidney transplantation due to the many advantages it offers over open nephrectomy, including significantly shorter hospitalization and recovery time, and significantly improved cosmetic result related to the nephrectomy scar(s). More recently, a new procedure has been introduced to the field of laparoscopic nephrectomy, called laparoendoscopic single site donor nephrectomy (LESS-DN). In the LESS-DN procedure, a single natural orifice (the umbilicus or belly button) is used as the single incision site through which the entire donor nephrectomy is performed. The LESS-DN procedure may further decrease donor morbidity by further decreasing length of stay, lessening recovery time, and improving satisfaction with the surgical scar. The investigators propose to evaluate conventional LDN versus a LESS-DN in a randomized, controlled trial in living kidney donors. The investigators will compare operative times and intra-operative donor management, intra- and post-operative complications, pain scores, analgesic requirements, length of stay, recovery parameters, surgical scar satisfaction, and function and survival of the transplanted kidney for the two groups of subjects: (1) the group that has the conventional laparoscopic donor nephrectomy; and, (2) the group that has the laparoendoscopic single site donor nephrectomy.
Interventions
PROCEDURELaparoendoscopic single site donor nephrectomy
Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
PROCEDUREConventional laparoscopic donor nephrectomy
Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity. | 1 year | The Primary Endpoint of the Study Will be Patient Self-reported Return to 100%, as Measured by the Number of Days Post-surgery That the Patient Reports His or Her Return to 100% Functioning Capacity. |
Secondary
| Measure | Time frame |
|---|---|
| Days on Oral Pain Medication After Discharge | 2 months |
| Days Before Going Back to Work | 2 months |
| Days to Normal Day-to-day Activities | 2 months |
| Recovered by 2 Months After Donation | 2 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LESS-DN Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy | 49 |
| Conventional LDN Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy | 51 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | Conventional LDN | LESS-DN |
|---|---|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 11.6 | 47.4 years STANDARD_DEVIATION 11.5 | 46.8 years STANDARD_DEVIATION 11.9 |
| Body Mass Index (BMI) BMI < 30 kg/m^2 | 72 participants | 36 participants | 36 participants |
| Body Mass Index (BMI) BMI >= 30 kg/m^2 | 28 participants | 15 participants | 13 participants |
| Multiple Arteries No | 88 participants | 45 participants | 43 participants |
| Multiple Arteries Yes | 12 participants | 6 participants | 6 participants |
| Race/Ethnicity, Customized African American | 14 participants | 9 participants | 5 participants |
| Race/Ethnicity, Customized All Other | 8 participants | 2 participants | 6 participants |
| Race/Ethnicity, Customized Caucasian | 59 participants | 31 participants | 28 participants |
| Race/Ethnicity, Customized Hispanic | 19 participants | 9 participants | 10 participants |
| Region of Enrollment United States | 100 participants | 51 participants | 49 participants |
| Relationship to Recipient Living Related | 45 participants | 24 participants | 21 participants |
| Relationship to Recipient Living Unrelated | 55 participants | 27 participants | 28 participants |
| Sex: Female, Male Female | 58 Participants | 29 Participants | 29 Participants |
| Sex: Female, Male Male | 42 Participants | 22 Participants | 20 Participants |
| Side of Donation (left) Left | 93 participants | 48 participants | 45 participants |
| Side of Donation (left) Right | 7 participants | 3 participants | 4 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 49 | 7 / 51 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 |
Outcome results
Primary
The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.
The Primary Endpoint of the Study Will be Patient Self-reported Return to 100%, as Measured by the Number of Days Post-surgery That the Patient Reports His or Her Return to 100% Functioning Capacity.
Time frame: 1 year
Population: The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LESS-DN | The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity. | 43 days | Standard Deviation 15 |
| Conventional LDN | The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity. | 45 days | Standard Deviation 22 |
Secondary
Days Before Going Back to Work
Time frame: 2 months
Population: The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LESS-DN | Days Before Going Back to Work | 24 days | Standard Deviation 14 |
| Conventional LDN | Days Before Going Back to Work | 27 days | Standard Deviation 18 |
Secondary
Days on Oral Pain Medication After Discharge
Time frame: 2 months
Population: The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LESS-DN | Days on Oral Pain Medication After Discharge | 6 days | Standard Deviation 4 |
| Conventional LDN | Days on Oral Pain Medication After Discharge | 7 days | Standard Deviation 8 |
Secondary
Days to Normal Day-to-day Activities
Time frame: 2 months
Population: The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LESS-DN | Days to Normal Day-to-day Activities | 30 days | Standard Deviation 17 |
| Conventional LDN | Days to Normal Day-to-day Activities | 33 days | Standard Deviation 25 |
Secondary
Recovered by 2 Months After Donation
Time frame: 2 months
Population: The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LESS-DN | Recovered by 2 Months After Donation | 35 participants |
| Conventional LDN | Recovered by 2 Months After Donation | 31 participants |