Not provided
Not provided
Not provided
Not provided
Not provided
Number of kidney donors decreased, not able to enroll subjects at this time
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A single-arm prospective internally-controlled study. Patients will undergo Percutaneous Externally-Assembled Laparoscopic (PEAL) donor nephrectomy where one or more 3 mm instruments are added or substituted for conventional 5 or 12 mm trocars. Multiple outcome measures (endpoints) will be measured including time to first opioid use, total inpatient opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to ambulation, length of hospital stay, presence of any intraoperative or postoperative complications, operating time, estimated blood loss, and other routine parameters collected in a prospective surgical study
Purpose:
Prior investigators have created methods to perform laparoscopic surgeries using smaller instruments and ports in an attempt to improve cosmesis and postoperative pain. However, These methods may be limited by the requirement for smaller instruments with decreased functionality or by the loss of instrument triangulation. We have previously published a study regarding the use of a new surgical paradigm (percutaneous externally assembled laparoscopy, or PEAL) in porcine and cadaveric models in order to allow laparoscopic surgery to take place with improved cosmesis and decreased pain while still allowing the use of larger instruments and maintaining instrument triangulation. We now seek to study the use of these instruments in the human patients undergoing laparoscopic urologic surgery.
The procedures include:
Hundred subjects will be recruited for the study with an expected attrition rate of 10%. Sample size has been minimized, but is necessary for statistical power and conclusions. Subjects will be male and female 18 years or older, of all ethnicities, denominations or other social/economical variations. All participants will speak English fluently in order for consent to be performed properly. Baseline pain score will be calculated through a questionnaire in at the urology clinic.
This is a single-arm prospective internally-controlled study. Patients will undergo percutaneous externally-assembled laparoscopic urologic surgery where one or more 3 mm instruments are added or substituted for conventional 5 or 12 mm trocars. Multiple outcome measures (endpoints) will be measured including time to first opioid use, total inpatient opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to ambulation, length of hospital stay, presence of any intraoperative or postoperative complications, operating time, estimated blood loss, and other routine parameters collected in a prospective surgical study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEAL laparoscopic nephrectomy | Experimental | Patients will undergo percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percuvance™ Percutaneous Surgical System | Device | Patients will undergo percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments are added or substituted for conventional 5 or 12 mm trocars. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Opioid Use | Measurement of time from leaving the post-anesthesia care unit after surgery until the time of first opioid dispersal, regardless of opioid type. | up to 1 day postoperatively |
| Total Inpatient Opioid Dosage | Total opioid dosage administered throughout the patient's inpatient stay. Measured in units of Morphine Milligram Equivalents (MME). | 3 days postoperatively |
| Pain Score of All Surgical Sites | A patient-reported pain score (on a scale of 1-10, with 10 being the worst) for each of the four port-site incisions, as measured by the Brief Pain Inventory. Scores were measured on both post-operative day one and on post-operative day two. The four port-site incisions which patients ranked pain scores for were: #1 - Hand-assist Port; #2 - 12 mm Port; #3 - 5 mm Port; #4 - Percutaneous Externally-Assembled Laparoscopic (PEAL) Port. A mean pain score was calculated by averaging the data across the two days. | up to 2 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Ileus | Duration of post-operative ileus as measured by days until return of normal bowel function was noted. | up to 3 days post-operatively |
| Time to Ambulation | Number of post-operative days before patient was noted to be ambulating. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Keheila, MD | Loma Linda University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda Medical Center | Loma Linda | California | 92350 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26732739 | Background | Arenas JL, Alsyouf M, Jang M, Myklak K, Faaborg D, Khater N, Baldwin DD. Percutaneous Externally Assembled Laparoscopic Instruments: Creation of a New Surgical Paradigm. J Endourol. 2016 Apr;30(4):433-40. doi: 10.1089/end.2015.0240. Epub 2016 Feb 9. | |
| 26386388 | Background | Rossitto C, Gueli Alletti S, Costantini B, Fanfani F, Scambia G. Total Laparoscopic Hysterectomy With Percutaneous (Percuvance) Instruments: New Frontier of Minimally Invasive Gynecological Surgery. J Minim Invasive Gynecol. 2016 Jan;23(1):14-5. doi: 10.1016/j.jmig.2015.09.004. Epub 2015 Sep 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PEAL Laparoscopic Nephrectomy | Patients who underwent Percutaneous Externally-Assembled Laparoscopic (PEAL) donor nephrectomy using 3 mm instruments. Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PEAL Laparoscopic Nephrectomy | Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments. Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Time to First Opioid Use | Measurement of time from leaving the post-anesthesia care unit after surgery until the time of first opioid dispersal, regardless of opioid type. | All patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy | Posted | Median | Full Range | minutes | up to 1 day postoperatively |
|
Up to patients' second clinical follow-up visit, occurring at approximately the six month mark.
Not different from clinicaltrials.gov definitions
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEAL Laparoscopic Nephrectomy | Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments. Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-operative nausea | Gastrointestinal disorders | Non-systematic Assessment | Self-limited post-operative nausea |
Although this was a prospective single-blinded study, it was limited by a modest sample size as the performance of donor nephrectomy surgeries transitioned to a separate surgical department not participating in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Duane Baldwin | Loma Linda University Health | 909-588-4000 | 44196 | dbaldwin@llu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2016 | Oct 10, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2016 | Aug 19, 2022 | ICF_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3 days post-operatively |
| Length of Hospital Stay | Number of days admitted to the hospital from surgery until hospital discharge | up do 4 days post-operatively |
| Presence of Intraoperative Complications | The number of patients with an intraoperative complication. | Intraoperatively |
| Length of Operative Time | Duration of surgical operation from incision time to procedure stop time | Intraoperatively (up to 6 hours) |
| Estimated Intraoperative Blood Loss | Estimated Blood Loss during the nephrectomy procedure | Intraoperatively (up to 6 hours) |
| 26618278 | Background | Chang J, Boules M, Rodriguez J, Kroh M. Minilaparoscopy with Interchangeable, Full 5-mm End Effectors: First Human Use of a New Minimally Invasive Operating Platform. J Laparoendosc Adv Surg Tech A. 2016 Jan;26(1):1-5. doi: 10.1089/lap.2015.0418. Epub 2015 Nov 30. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Total Inpatient Opioid Dosage | Total opioid dosage administered throughout the patient's inpatient stay. Measured in units of Morphine Milligram Equivalents (MME). | Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | 3 days postoperatively |
|
|
|
| Primary | Pain Score of All Surgical Sites | A patient-reported pain score (on a scale of 1-10, with 10 being the worst) for each of the four port-site incisions, as measured by the Brief Pain Inventory. Scores were measured on both post-operative day one and on post-operative day two. The four port-site incisions which patients ranked pain scores for were: #1 - Hand-assist Port; #2 - 12 mm Port; #3 - 5 mm Port; #4 - Percutaneous Externally-Assembled Laparoscopic (PEAL) Port. A mean pain score was calculated by averaging the data across the two days. | Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy | Posted | Mean | Standard Deviation | score on a scale | up to 2 days postoperatively |
|
|
|
| Secondary | Post-operative Ileus | Duration of post-operative ileus as measured by days until return of normal bowel function was noted. | Patients who underwent donor nephrectomy | Posted | Median | Full Range | days | up to 3 days post-operatively |
|
|
|
| Secondary | Time to Ambulation | Number of post-operative days before patient was noted to be ambulating. | Patients who underwent donor nephrectomy | Posted | Median | Full Range | days | 3 days post-operatively |
|
|
|
| Secondary | Length of Hospital Stay | Number of days admitted to the hospital from surgery until hospital discharge | Patients who underwent donor nephrectomy | Posted | Mean | Standard Deviation | days | up do 4 days post-operatively |
|
|
|
| Secondary | Presence of Intraoperative Complications | The number of patients with an intraoperative complication. | Patients who underwent donor nephrectomy | Posted | Count of Participants | Participants | Intraoperatively |
|
|
|
| Secondary | Length of Operative Time | Duration of surgical operation from incision time to procedure stop time | Patients who underwent donor nephrectomy | Posted | Mean | Standard Deviation | hours | Intraoperatively (up to 6 hours) |
|
|
|
| Secondary | Estimated Intraoperative Blood Loss | Estimated Blood Loss during the nephrectomy procedure | Patients who underwent donor nephrectomy | Posted | Mean | Standard Deviation | mL | Intraoperatively (up to 6 hours) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
|
| Post-operative dizziness | Nervous system disorders | Non-systematic Assessment | Self-limited post-operative dizziness |
|
Not provided
Not provided
Not provided