Trial Outcomes & Findings for Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation (NCT NCT01236326)
NCT ID: NCT01236326
Last Updated: 2019-06-12
Results Overview
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.
COMPLETED
NA
105 participants
1 year
2019-06-12
Participant Flow
Participant milestones
| Measure |
LESS-DN
Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
|
Conventional LDN
Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
55
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation
Baseline characteristics by cohort
| Measure |
LESS-DN
n=49 Participants
Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
|
Conventional LDN
n=51 Participants
Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
47.4 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
47.1 years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 participants
n=99 Participants
|
9 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
28 participants
n=99 Participants
|
31 participants
n=107 Participants
|
59 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
All Other
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=99 Participants
|
51 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Relationship to Recipient
Living Related
|
21 participants
n=99 Participants
|
24 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Relationship to Recipient
Living Unrelated
|
28 participants
n=99 Participants
|
27 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
Side of Donation (left)
Left
|
45 participants
n=99 Participants
|
48 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
Side of Donation (left)
Right
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Body Mass Index (BMI)
BMI < 30 kg/m^2
|
36 participants
n=99 Participants
|
36 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
Body Mass Index (BMI)
BMI >= 30 kg/m^2
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Multiple Arteries
Yes
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Multiple Arteries
No
|
43 participants
n=99 Participants
|
45 participants
n=107 Participants
|
88 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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).
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.
Outcome measures
| Measure |
LESS-DN
n=36 Participants
Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
|
Conventional LDN
n=39 Participants
Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
|
|---|---|---|
|
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
|
45 days
Standard Deviation 22
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: 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).
Outcome measures
| Measure |
LESS-DN
n=36 Participants
Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
|
Conventional LDN
n=39 Participants
Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
|
|---|---|---|
|
Days on Oral Pain Medication After Discharge
|
6 days
Standard Deviation 4
|
7 days
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: 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).
Outcome measures
| Measure |
LESS-DN
n=36 Participants
Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
|
Conventional LDN
n=39 Participants
Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
|
|---|---|---|
|
Days Before Going Back to Work
|
24 days
Standard Deviation 14
|
27 days
Standard Deviation 18
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: 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).
Outcome measures
| Measure |
LESS-DN
n=36 Participants
Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
|
Conventional LDN
n=39 Participants
Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
|
|---|---|---|
|
Days to Normal Day-to-day Activities
|
30 days
Standard Deviation 17
|
33 days
Standard Deviation 25
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: 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).
Outcome measures
| Measure |
LESS-DN
n=36 Participants
Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
|
Conventional LDN
n=39 Participants
Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
|
|---|---|---|
|
Recovered by 2 Months After Donation
|
35 participants
|
31 participants
|
Adverse Events
LESS-DN
Conventional LDN
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LESS-DN
n=49 participants at risk
Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
|
Conventional LDN
n=51 participants at risk
Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
|
|---|---|---|
|
Renal and urinary disorders
Conversion to Hand Assist Laparoscopy
|
6.1%
3/49 • Number of events 3
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Ileus within 30 days
|
0.00%
0/49
|
2.0%
1/51 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.1%
3/49 • Number of events 3
|
0.00%
0/51
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/49
|
2.0%
1/51 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/49
|
2.0%
1/51 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Superficial Surgical Site Infection
|
4.1%
2/49 • Number of events 2
|
0.00%
0/51
|
|
Renal and urinary disorders
Urinary Retention
|
2.0%
1/49 • Number of events 1
|
0.00%
0/51
|
|
General disorders
Re-admission
|
0.00%
0/49
|
3.9%
2/51 • Number of events 2
|
Additional Information
Meredith J. Aull, Pharm.D.
Weill Cornell Medical College
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place