Trial Outcomes & Findings for Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation (NCT 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

105 participants

Primary outcome timeframe

1 year

Results posted on

2019-06-12

Participant Flow

Participant milestones

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

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=5 Participants	47.4 years STANDARD_DEVIATION 11.5 • n=7 Participants	47.1 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized African American	5 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	28 participants n=5 Participants	31 participants n=7 Participants	59 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Race/Ethnicity, Customized All Other	6 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	51 participants n=7 Participants	100 participants n=5 Participants
Relationship to Recipient Living Related	21 participants n=5 Participants	24 participants n=7 Participants	45 participants n=5 Participants
Relationship to Recipient Living Unrelated	28 participants n=5 Participants	27 participants n=7 Participants	55 participants n=5 Participants
Side of Donation (left) Left	45 participants n=5 Participants	48 participants n=7 Participants	93 participants n=5 Participants
Side of Donation (left) Right	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Body Mass Index (BMI) BMI < 30 kg/m^2	36 participants n=5 Participants	36 participants n=7 Participants	72 participants n=5 Participants
Body Mass Index (BMI) BMI >= 30 kg/m^2	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants
Multiple Arteries Yes	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Multiple Arteries No	43 participants n=5 Participants	45 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

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 months

Outcome measures

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 months

Outcome measures

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 months

Outcome measures

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 months

Outcome measures

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

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Conventional LDN

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: (212) 746-0727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place