1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Data are available indefinitely at (Link to be included karthik.nvkn@gmail.com).
   


6. For how long will this data be available start date provided 02-05-2023 and end date provided 02-01-2060?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Kidney transplantation is the standard of care with end-stage renal disease as it provides better quality of life, longer survival and cost effectiveness compared to dialysis. The increased numbers of living donors have made attention to donor well-being a priority, leading to the widespread adoption of minimally invasive donor nephrectomy [1]. Living donor nephrectomy (LDN) allows reduction of time on waiting list for kidney transplant. Since it is performed on healthy voluntary subjects, safety and effectiveness of the surgery are crucial. Minimizing the complication rate, reducing the length of stay in hospital, promoting faster recovery, and the return to normal professional activity are key to increase the number of donors for transplantation. LDN complication rates have been reported to range between 5% to 10%[2].

There is a learning curve when performing LDN. The United Network of Organ Sharing(UNOS) requires 15 cases as surgeon or assistant to be certified as the primary LDN surgeon[3]. LDN needs meticulous vascular dissection and rapid specimen extraction to minimize warm ischemia time. Several techniques of minimally invasive donor nephrectomy have been described in multiple studies of which hand-assisted laparoscopic nephrectomy (HADN) has been shown to be associated with decreased operative time, warm ischemia time (WIT) and intraoperative bleeding with similar donor and recipient outcomes when compared with pure total laparoscopic donor nephrectomy (TLDN). Improvement in operative technique markedly decreases operative time and improves perioperative graft function[4-8].

Minimally invasive donor nephrectomy in an academic program present new challenges for surgical teams because of WIT, intraoperative bleeding and complications which can be affected by the learning curve of trainees. Therefore, properly supervised surgical training is must as it allows a gradual increase in proficiency without compromising donor safety and surgical outcomes[2, 9].

Some studies report that HADN is associated with reduced operative time, blood loss and postoperative complications without increasing total hospital charges or length of stay compared with TLDN [3, 10-14]. Contrary to this, other studies show that TLDN is better compared to HADN in terms of WIT, time to first oral intake, length of hospital stay (LOS), and post-operative donor complications[15].

Learning curve seems to be longer with TLDN[14]. At some centres, HADN is first used for training residents as it is reportedly easier to learn, improving operative times as early as by fourth case. There is reportedly rapid increase in proficiency under the mentorship of an experienced transplant surgeon without additional donor morbidity. However objective measures of surgical training are vaguely described[3, 7, 14, 16]. Studies also show there is a initial period of rapid learning followed by a plateau in competency with increasing case experience, the maximum variability being in colon mobilisation and hilar dissection[17]. The technical transition from HADN to TLDN does not appear to have as steep a learning curve showing similar perioperative donor and graft outcomes[1]. Safety of the donor with LDN experience showed it can be learned safely under guidance of mentor surgeon without affecting learning curve and donor outcome[16].

While there are comparative studies of laparoscopic vs hand assisted donor nephrectomy, no studies have looked into the learning curve for the training surgeon prospectively. A hand assisted approach can possibly shorten the learning curve because of the benefit of additional tactile sensation during HADN. Therefore, the present study is proposed to compare the learning curves in HADN versus TLDN for trainees assisting/performing laparoscopic donor nephrectomy. The development of a teaching hospital LDN program (HADN & TLDN) to expedite learning curve may improve both donor and recipient outcomes, reduce the probable complications and facilitate the transition from trainee to proficient surgeon.

REVIEW OF LITERATURE:

Ratner et al first described laparoscopic donor nephrectomy (LDN) for living donation in 1995. It has been preferred due to its, lower hospital stay, shorter time of recovery better aesthetic results after LDN while preserving graft quality in the recipients[2]. It provides an opportunity to expand the donor pool. Laparoscopic donor nephrectomy poses a great challenge in the sense that the kidney must be safely extracted out for transplantation. In this sense, hand assisted donor nephrectomy has better learning experience due to tactile control. Nakada et al performed the first hand-assisted laparoscopic donor nephrectomy (HADN) in 1997. The potential benefits of this technique included the ability to shorten and thereby more easily overcome the learning curve associated with LDN[14].

The Organ Procurement and Transplantation Network policy dictates that to be the primary surgeon in an LDN in the United States, at least 15 cases must be performed in the last 5 years, and out of those, at least 7 must be performed as a main surgeon[2]. Saad et al suggested that 10 cases were enough to complete the LC[18] whereas Barth et al and Troppmann et al have reported a cut-off point of 60 and 50 LDNs, respectively[19, 20]. A systematic review conducted by Raque et al [3] in 2015 found that the tipping point to reach the LC was 24 to 28 cases and a volume of 50 cases per year in the transplantation centre. The majority of the studies consider 30 cases to be an adequate number of LDN to be efficient[3].

Gaston et al in their experience of 100 patients who underwent LDN, learning curve outcomes were analyzed and the results were divided by the case experience of the first 50 cases versus the second 50 cases. Mean operative time for the initial 50 cases were 175 minutes compared to 163 minutes for the later 50 cases (p = 0.02)[14]. When stratified by experience, the mean operative time for the first HADN case by residents was 178 minutes compared to 91 minutes for case 6 by residents. Overall, HADN can be taught to residents in training as the learning curve may be surmounted as early as the fourth case[14].

Leventhal et al found that majority of their complications occurred during their first 30 cases and four of five conversions occurred in the first 40 cases[21]. Raque et al analysed 381 LDN which showed decrease in graft loss with increasing experience.[3]

Friedersdorff et al found that the novice surgeon had longer total operating times and warm ischaemia times than the expert surgeon. High recipient BMI and prolonged WIT were identified as risk factors for poor early graft function. They found a higher incidence of acute rejection and DGF rates as well a slower recovery of recipient serum creatinine in the novice group[22]. Nogueira [23] et al. in that prolonged warm ischaemia times during LLDN may translate into higher DGF and acute rejection rates. However, Chin et al found that, despite longer operating times and warm ischaemia times, donor and graft outcomes are excellent during a surgeon’s initial LLDN experience[24].

Hollenbeck et al found that trainee surgeon participating in 13 laparoscopic donor nephrectomies resulted in shorter operative times. Other skill measures like intraoperative complications and blood loss did not prove useful in documenting change with experience. Our multivariate analysis confirmed that more frequent participation in HADN, regardless of the role, was independently associated with improvements in operative time. Higher body mass index (BMI) was associated with longer operative times to difficulty in manoeuvrability via hand port. This is overcome by repeated exposure to the technique[25]. Increasing blood loss did not correlate with any of measures of experience[25, 26].

Dalla et al experience with LDN confirmed the feasibility of the technique after an adequate but limited period of training. Mean operative time was slightly longer in novice group. WIT was the only factor that showed a significant difference between the two groups (P=.035). However, no adverse events on graft function were noted[27]. In one series, WIT was lower in the HADN group than TLDN group (3.0 vs 3.2minutes; P0.59), but still longer than in the ODN group (3.0 vs 1.7 minutes)[28].

Meta-analysis has shown that the hand-assisted procedure offered advantages in terms of shorter operating and warm ischemia times[8, 15]. Total TLDN is also a safe and effective alternative when it comes to cosmetic concerns and surgeons’ preference[11].

Conversions were more likely to happen early in the learning curve. 19 of the 44 papers reviewed reported at least one laparoscopic conversion to open. It is important that a training program for LDN includes training on why and how to make the decision to open, as well as how to open expeditiously[3]. Vascular anatomy did not appreciably influence operative difficulty. This usually don’t cause significant difficulty if detected on preoperative imaging studies[29]. Higher BMI was associated with a significantly longer mean operative time (BMI 25 kg/m2, 197 min; BMI 30, 225 min) (P= 0.03), which was predominantly related to the prolonged mean time to mobilize the colon (BMI 25 kg/m2, 26 min; BMI 30, 35 min (P= 0.01). Colon mobilization and renal hilum dissection were most correlated with overall operative time[17].

Kercher et al described outcomes of 119 patients between HADN and TLDN which showed equivalent length of stay (3.68 days vs. 3.72 days, P = 0.15) for both HADN and TLDN. Mean operative time and blood loss for HADN was less (202 minutes vs. 258 minutes, P = 0.0001),  (71.7 cc vs. 113.1 cc, P = 0.007) respectively[13].

Baez et al reported series of 492 HADNs before and after completing learning curve (50 cases each) There were significant differences between the 2 groups in operating time, blood loss, and length of stay (P < .05). No differences were found in terms of complication (P = .42) and conversion (P = .28) rates[2].

Lai et al compared the outcome of (HLDN) (n=51) and (TLDN)(n=42)[11].The operation time of HLDN group (188±62min) was less than TLDN group’s (207±30min) (p=0.065). The operation time of the first 24 cases (237±66min) was significantly longer than that of the later 69 performed (180±35min). The WIT was shorter in HLDN (2.5±1.3min) compared to that of TLDN (4.1±1.7min) (p<0.01), but the serum creatinine values (mg/dL) of recipients were equivalent (HLDN/TLDN = 1.18 ± 0.3:1.14 ± 0.3, p =0.587). There was no difference in the length of hospital stay (6.7 vs. 6.4days, p=0.475). There was a learning curve in establishing the technique of laparoscopic donor nephrectomy showing that a well-cooperative team could perform the training of novice surgeons safely and efficiently [11].

Branco et al compared HADN(n=67) and TLDN(n=89) in 156 donors studied retrospectively which is in contrast to other studies showing less operative duration, warm ischemia time and intra-operative bleeding in TLDN (78.4 min, 2.5 min and 98.9 cc) than HADN (83 min, 3.6 min and 130.9 cc) with p values of (p=0.29, p<0.0001 and p=0.08) respectively. TLDN donors had early first meals (12.5 vs. 9.2 hours, p=0.046), less hospital stay duration (2.8 vs. 1.4 days, p<0.0001) and less postoperative complications (7.5% vs. 0.6%, p=0.04[15].

Lai et al studied compared donor outcome of HADN with TLDN in 12 donors each. Both techniques had similar good early graft function. The mean operation time in TLDN (215 minutes) shorter than that in HADN (258 minutes), This is in contrary to other studies which showed operative time is less in HADN group. The mean WIT of the TLDN group (4.5 minutes) was longer than that of the HADN group (3.8 minutes) The length of hospital stay, resumption of diet, and the use of narcotic analgesics were not different between the 2 groups[11, 12]. These differences are due to the fact the TLDN were performed after initial training with HADN.

There is no gold standard to measure operators’ performance during laparoscopic surgery. A measure of intraoperative laparoscopic performance is useful not only in training but also in evaluation. Several global rating scales of evaluation of technical skill was described in various general surgical procedures[30], but none have been documented in LDN. Operative parameters like time to complete individual steps of surgery can be a surrogate to measure performance. A progressive reduction in operative times has been taken as a marker to achieve proficiency in donor nephrectomy[3]. The present study plans to compare the time taken to complete individual steps of donor nephrectomy by the trainee surgeon while doing HADN vs TLDN with ensuring donor safety. 

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2.            Baez-Suarez Y, Amaya-Nieto J, Garcia-Lopez A, Giron-Luque F: Hand-assisted Laparoscopic Nephrectomy: Evaluation of the Learning Curve. Transplantation proceedings 2020, 52(1):67-72.

3.            Raque J, Billeter AT, Lucich E, Marvin MM, Sutton E: Training techniques in laparoscopic donor nephrectomy: a systematic review. Clinical transplantation 2015, 29(10):893-903.

4.            Halgrimson WR, Campsen J, Mandell MS, Kelly MA, Kam I, Zimmerman MA: Donor complications following laparoscopic compared to hand-assisted living donor nephrectomy: an analysis of the literature. J Transplant 2010, 2010:825689.

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14.          Gaston KE, Moore DT, Pruthi RS: Hand-Assisted Laparoscopic Nephrectomy:: Prospective Evaluation of the Learning Curve. The Journal of Urology 2004, 171(1):63-67.

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