Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01236326
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Living Donors; Nephrectomy; Kidney Transplantation; Surgery, Laparoscopic	Procedure: Laparoendoscopic single site donor nephrectomy; Procedure: Conventional laparoscopic donor nephrectomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Prospective, Parallel Group Study of Conventional Laparoscopic Donor Nephrectomy (LDN) Versus Laparoendoscopic Single Site Donor Nephrectomy (LESS-DN) in Living Donor Kidney Transplantation
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LESS-DN	Procedure: Laparoendoscopic single site donor nephrectomy; Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
Active Comparator: Conventional LDN	Procedure: Conventional laparoscopic donor nephrectomy; Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Days on Oral Pain Medication After Discharge [2 months]

2. Days Before Going Back to Work [2 months]

3. Days to Normal Day-to-day Activities [2 months]

4. Recovered by 2 Months After Donation [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NewYork-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Joseph J Del Pizzo, M.D., Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01236326
• Other Study ID Numbers: 1009011249
• First Posted: Nov 7, 2010
• Last Update Posted: Jun 12, 2019
• Last Verified: May 1, 2019

Study Results

Participant Flow

Arm/Group Title	LESS-DN	Conventional LDN
Arm/Group Description	Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy	Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
Period Title: Overall Study
STARTED	50	55
COMPLETED	49	51
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	LESS-DN	Conventional LDN	Total
Arm/Group Description	Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy	Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy	Total of all reporting groups
Overall Participants	49	51	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.8 (11.9)	47.4 (11.5)	47.1 (11.6)
Sex: Female, Male (Count of Participants)
Female	29 59.2%	29 56.9%	58 58%
Male	20 40.8%	22 43.1%	42 42%
Race/Ethnicity, Customized (participants) [Number]
African American	5 10.2%	9 17.6%	14 14%
Caucasian	28 57.1%	31 60.8%	59 59%
Hispanic	10 20.4%	9 17.6%	19 19%
All Other	6 12.2%	2 3.9%	8 8%
Region of Enrollment (participants) [Number]
United States	49 100%	51 100%	100 100%
Relationship to Recipient (participants) [Number]
Living Related	21 42.9%	24 47.1%	45 45%
Living Unrelated	28 57.1%	27 52.9%	55 55%
Side of Donation (left) (participants) [Number]
Left	45 91.8%	48 94.1%	93 93%
Right	4 8.2%	3 5.9%	7 7%
Body Mass Index (BMI) (participants) [Number]
BMI < 30 kg/m^2	36 73.5%	36 70.6%	72 72%
BMI >= 30 kg/m^2	13 26.5%	15 29.4%	28 28%
Multiple Arteries (participants) [Number]
Yes	6 12.2%	6 11.8%	12 12%
No	43 87.8%	45 88.2%	88 88%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	LESS-DN	Conventional LDN
Arm/Group Description	Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy	Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
Measure Participants	36	39
Mean (Standard Deviation) [days]	43 (15)	45 (22)

2. Secondary Outcome

Title	Days on Oral Pain Medication After Discharge
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

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/Group Title	LESS-DN	Conventional LDN
Arm/Group Description	Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy	Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
Measure Participants	36	39
Mean (Standard Deviation) [days]	6 (4)	7 (8)

3. Secondary Outcome

Title	Days Before Going Back to Work
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

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/Group Title	LESS-DN	Conventional LDN
Arm/Group Description	Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy	Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
Measure Participants	36	39
Mean (Standard Deviation) [days]	24 (14)	27 (18)

4. Secondary Outcome

Title	Days to Normal Day-to-day Activities
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

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/Group Title	LESS-DN	Conventional LDN
Arm/Group Description	Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy	Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
Measure Participants	36	39
Mean (Standard Deviation) [days]	30 (17)	33 (25)

5. Secondary Outcome

Title	Recovered by 2 Months After Donation
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

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/Group Title	LESS-DN	Conventional LDN
Arm/Group Description	Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy	Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
Measure Participants	36	39
Number [participants]	35 71.4%	31 60.8%

Adverse Events

Arm/Group Title	LESS-DN		Conventional LDN
Arm/Group Description	Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy		Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
All Cause Mortality
	LESS-DN		Conventional LDN
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LESS-DN		Conventional LDN
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	LESS-DN		Conventional LDN
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/49 (18.4%)		7/51 (13.7%)
Gastrointestinal disorders
Ileus within 30 days	0/49 (0%)	0	1/51 (2%)	1
General disorders
Re-admission	0/49 (0%)	0	2/51 (3.9%)	2
Nervous system disorders
Neuropathy	0/49 (0%)	0	1/51 (2%)	1
Renal and urinary disorders
Conversion to Hand Assist Laparoscopy	3/49 (6.1%)	3	2/51 (3.9%)	2
Urinary Retention	1/49 (2%)	1	0/51 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hypoxia	3/49 (6.1%)	3	0/51 (0%)	0
Pulmonary Embolism	0/49 (0%)	0	1/51 (2%)	1
Skin and subcutaneous tissue disorders
Superficial Surgical Site Infection	2/49 (4.1%)	2	0/51 (0%)	0

Limitations/Caveats

Inability to secure complete data on the donor questionnaires (25% of subjects did not return 2-month questionnaire); no validated tool available to assess donor recovery and satisfaction; clinical donor follow-up was suboptimal.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.