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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LESS-DN | Active Comparator |
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| Conventional LDN | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoendoscopic single site donor nephrectomy | Procedure | Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph J Del Pizzo, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NewYork-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | LESS-DN | Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy |
| FG001 | Conventional LDN | Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Conventional laparoscopic donor nephrectomy | Procedure | Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy |
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| 2 months |
| Recovered by 2 Months After Donation | 2 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LESS-DN | Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy |
| BG001 | Conventional LDN | Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Relationship to Recipient | Number | participants |
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| Side of Donation (left) | Number | participants |
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| Body Mass Index (BMI) | Number | participants |
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| Multiple Arteries | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Deviation | days | 1 year |
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| Secondary | Days on Oral Pain Medication After Discharge | 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). | Posted | Mean | Standard Deviation | days | 2 months |
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| Secondary | Days Before Going Back to Work | 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). | Posted | Mean | Standard Deviation | days | 2 months |
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| Secondary | Days to Normal Day-to-day Activities | 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). | Posted | Mean | Standard Deviation | days | 2 months |
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| Secondary | Recovered by 2 Months After Donation | 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). | Posted | Number | participants | 2 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LESS-DN | Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy | 0 | 49 | 9 | 49 | ||
| EG001 | Conventional LDN | Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy | 0 | 51 | 7 | 51 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conversion to Hand Assist Laparoscopy | Renal and urinary disorders | Systematic Assessment | For bleeding, difficult dissection, or difficult mobilization |
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| Ileus within 30 days | Gastrointestinal disorders | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Neuropathy | Nervous system disorders | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Superficial Surgical Site Infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
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| Re-admission | General disorders | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith J. Aull, Pharm.D. | Weill Cornell Medical College | (212) 746-0727 | mea9008@med.cornell.edu |
| Male |
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| Caucasian |
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| Hispanic |
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| All Other |
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| Living Unrelated |
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| Right |
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| BMI >= 30 kg/m^2 |
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| No |
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