the prevalence of renal stone disease ranges from 420% with geographic variations . with the advent of endourological and non - invasive interventions , the management of renal calculi has witnessed a marked improvement in outcome . percutaneous nephrolithotomy ( pnl ) is one of the most commonly performed endourological procedures for stone management . pnl results in earlier stone - free status with lesser need of auxiliary procedures when compared to extra - corporeal shock wave lithotripsy ( eswl ) . however , one of the limiting factors of pnl over eswl has been the need for hospitalization in the former , while the latter is a day care procedure . reasons for perioperative hospitalization for pnl include the feared risk of bleeding from the access tract , nephrostomy tube management , fever , risk of sepsis or the need for a re - look procedure . few series have evaluated the feasibility and efficacy of the hemostatic tract sealants as an adjunct to tubeless pnl . therefore , a randomized study for the head - to - head comparison of standard pnl using a nephrostomy tube with tubeless pnl using a composite hemostatic seal on a day care basis is needed . this randomized controlled study was conducted to compare the outcome of tubeless day care pnl using an indigenous composite hemostatic access tract seal with standard pnl , where the cases were admitted preoperatively and a nephrostomy tube was placed at the end of surgery . inclusion criteria were patients more than 18 years of age , body - mass index ( bmi ) less than 30 kg / m , isolated pelvic or pelvicalyceal calculi with the total stone burden less than 40 mm , no anatomical abnormalities , normal renal function , american society of anaesthesiologists ( asa ) grade 1 or 2 , residence within a short distance in order to have the ability to report to a hospital within an hour of any adverse complications and motivated and compliant with the instructions provided . exclusion criteria included patients with bmi 30 kg / m , staghorn calculi , concomitant urinary tract infection , previous renal surgery , congenital anomalies , solitary kidney , patients without adequate family support or patients not willing for either day care or standard pnl . patients who were eligible for the study were randomized using a computer - generated table to either the day care surgery with seal ( dcs)group or the control group . cases in whom any of the following intraoperative events occurred were excluded from the final analysis . these intraoperative events were more than two access tracts , intraoperative bleeding needing transfusion , perforation of the pelvicalyceal system , anesthesia related complications , residual stone needing a re - look pnl or a procedure lasting more than 2 hours . the tract was dilated using a 12fr amplatz fascial dilator ( cook medical , usa ) followed by a cobra catheter ( cook medical , usa ) , 30fr amplatz dilator ( cook medical , usa ) and lastly , a 30fr amplatz sheath insertion . a rigid nephroscope ( 27-french , karl storz , germany ) was used . for lithotripsy : swiss pneumatic lithoclast was implemented . in the dcs group , santosh - pgi hemostatic seal. the steps of seal deployment are highlighted in figure 1 . following the stone clearance , the amplatz access sheath was withdrawn to the junction of pelvicalyceal system with the parenchyma . approximate length of the seal was determined by subtracting the length of the amplatz sheath outside the skin surface from the total length of the sheath . the composite seal was prepared by wrapping a strip of oxidized regenerated cellulose over a gelatin - sponge and was soaked in a solution of 250 mg of tranexamic acid with 5 ml of 1:1000 dilution of noradrenaline and 20 ml of 76% trazograf . the seal was deployed by pushing the seal through the amplatz sheath under fluoroscopic guidance using the non - conical end of the amplatz dilator as the plunger up to the level of the skin surface ( figure 1 ) . keeping the plunger position stable , the skin was sutured with a nylon 2 - 0 suture on a curved cutting needle . santosh - pgi refers to the name of the urologist ( santosh ) and the institute ( post - graduate institute of medical education and research , chandigarh , india ) where the study was conducted . the constituents of the seal included a strip of oxidized regenerated cellulose ( surgicel from ethicon , a division of johnson and johnson , new jersey , usa ) , 80 x 50 x 10 mm gelatin - sponge ( gelspon from eucare pharmaceuticals , india ) , 250 mg tranexamic acid ( inj . tenacid from leeford healthcare , india ) , 5ml of 1:1000 dilution of nor - adrenaline ( injection adrenor from samarth pharma , india ) and 20 ml of 76% iodinated contrast agent ( injection trazograf 76% , from jb chemicals and pharmaceuticals ltd . , india ) . x - ray kub of the patient showing left renal calculi ( a ) , tract dilatation using amplatz dilator and sheath ( b ) , the target calculus ( c ) , following stone clearance the amplatz sheath withdrawn up to parenchymal margin ( d ) , components of composite seal ( e ) , seal prepared ( f ) , seal being deployed ( g ) , fluoroscopic view of deployed seal ( h ) . in the control group , once the urine was clear and the patient had no fever , the nephrostomy was clamped on the third postoperative day . postoperative parameters that were recorded included the verbal numerical rating score ( vnrs 1 to 10 ) for pain at the 6 hour , paracetamol analgesic requirements ( in the recovery room and thereafter rescue analgesics ) , the need for blood transfusion , urinary leakage from the wound or peri - nephrostomy leak , fever , postoperative drop in hemoglobin and the duration of hospital stay . patients in the dcs group were discharged within 24 hours if they were afebrile with no hematuria and minimal to no pain . they were also prescribed rescue analgesics ( paracetamol 650 mg ) and were instructed to take them when they felt that the pain was severe or intolerable . they were advised to keep a record of the days of analgesic intake and the number of times the drug was taken on that day . they were asked to report to the emergency department in case of hematuria , urinary soakage , intractable pain or fever . patients in the control group were shifted to the ward and were discharged later after the removal of the nephrostomy tube . the patients were followed up at the end of 6 weeks . at follow - up , the parameters evaluated were rescue analgesic requirements , any complications , readmissions and days needed to return to normal work . the primary goal of the study was to assess whether the use of hemostatic seal without nephrostomy would result in a significant reduction in hemoglobin and analgesic requirement . the secondary endpoints were to assess the feasibility of the day care protocol for pnl and whether it would help in the earlier resumption of normal daily activities . for normally distributed data , continuous variables were compared using the student t test . for skewed data , pearson chi - square test and the fisher exact test were implemented for comparison of qualitative variables . patients were operated under general anesthesia . initially , a 6fr ureteric access catheter was placed using a cystoscope . the tract was dilated using a 12fr amplatz fascial dilator ( cook medical , usa ) followed by a cobra catheter ( cook medical , usa ) , 30fr amplatz dilator ( cook medical , usa ) and lastly , a 30fr amplatz sheath insertion . a rigid nephroscope ( 27-french , karl storz , germany ) was used . for lithotripsy : swiss pneumatic lithoclast was implemented . in the dcs group , santosh - pgi hemostatic seal. the steps of seal deployment are highlighted in figure 1 . following the stone clearance , the amplatz access sheath was withdrawn to the junction of pelvicalyceal system with the parenchyma . approximate length of the seal was determined by subtracting the length of the amplatz sheath outside the skin surface from the total length of the sheath . the composite seal was prepared by wrapping a strip of oxidized regenerated cellulose over a gelatin - sponge and was soaked in a solution of 250 mg of tranexamic acid with 5 ml of 1:1000 dilution of noradrenaline and 20 ml of 76% trazograf . the seal was deployed by pushing the seal through the amplatz sheath under fluoroscopic guidance using the non - conical end of the amplatz dilator as the plunger up to the level of the skin surface ( figure 1 ) . keeping the plunger position stable , the skin was sutured with a nylon 2 - 0 suture on a curved cutting needle . santosh - pgi refers to the name of the urologist ( santosh ) and the institute ( post - graduate institute of medical education and research , chandigarh , india ) where the study was conducted . the constituents of the seal included a strip of oxidized regenerated cellulose ( surgicel from ethicon , a division of johnson and johnson , new jersey , usa ) , 80 x 50 x 10 mm gelatin - sponge ( gelspon from eucare pharmaceuticals , india ) , 250 mg tranexamic acid ( inj . tenacid from leeford healthcare , india ) , 5ml of 1:1000 dilution of nor - adrenaline ( injection adrenor from samarth pharma , india ) and 20 ml of 76% iodinated contrast agent ( injection trazograf 76% , from jb chemicals and pharmaceuticals ltd . , india ) . x - ray kub of the patient showing left renal calculi ( a ) , tract dilatation using amplatz dilator and sheath ( b ) , the target calculus ( c ) , following stone clearance the amplatz sheath withdrawn up to parenchymal margin ( d ) , components of composite seal ( e ) , seal prepared ( f ) , seal being deployed ( g ) , fluoroscopic view of deployed seal ( h ) . in the control group , an 18 french nephrostomy tube was placed . once the urine was clear and the patient had no fever , the nephrostomy was clamped on the third postoperative day . postoperative parameters that were recorded included the verbal numerical rating score ( vnrs 1 to 10 ) for pain at the 6 hour , paracetamol analgesic requirements ( in the recovery room and thereafter  rescue analgesics ) , the need for blood transfusion , urinary leakage from the wound or peri - nephrostomy leak , fever , postoperative drop in hemoglobin and the duration of hospital stay . patients in the dcs group were discharged within 24 hours if they were afebrile with no hematuria and minimal to no pain . they were also prescribed rescue analgesics ( paracetamol 650 mg ) and were instructed to take them when they felt that the pain was severe or intolerable . they were advised to keep a record of the days of analgesic intake and the number of times the drug was taken on that day . they were asked to report to the emergency department in case of hematuria , urinary soakage , intractable pain or fever . patients in the control group were shifted to the ward and were discharged later after the removal of the nephrostomy tube . the patients were followed up at the end of 6 weeks . at follow - up , the parameters evaluated were rescue analgesic requirements , any complications , readmissions and days needed to return to normal work . the primary goal of the study was to assess whether the use of hemostatic seal without nephrostomy would result in a significant reduction in hemoglobin and analgesic requirement . the secondary endpoints were to assess the feasibility of the day care protocol for pnl and whether it would help in the earlier resumption of normal daily activities . for normally distributed data , continuous variables were compared using the student t test . for skewed data , pearson chi - square test and the fisher exact test were implemented for comparison of qualitative variables . a p - value of < 0.05 was considered as statistically significant . finally , 122 cases were randomized to either day care surgery with the seal group ( dcs ) or the control group ( figure 2 ) . five cases in the dcs group and 4 cases in the control group were excluded due to intraoperative adverse events . finally , 56 cases in the dcs group and 57 in the control group were included for analysis . consort flow diagram of the study . the baseline demographic profile , stone characteristics and operative profiles were comparable in both the groups ( table 1 ) . in the dcs group , 58.9% of the cases were male with mean age of 36.20 13.32 years . seventy - five percent of the cases in the dcs group while 71.9% in the control group had a single calculus . mean preoperative hemoglobin and serum creatinine levels were comparable in both the groups ( 13.20 1.85 vs. 12.78 1.75 ; p = 0.216 and 0.86 0.19 vs. 0.79 0.19 ; p = 0.071 , respectively ) . majority of the cases in both the dcs and control groups needed a single access tract ( 94.6 vs. 96.5% respectively ; p = 0.63 ) and an inferior calyceal access ( 78.5% vs. 59.6% respectively ; p = 0.09 ) . the mean duration of surgery was comparable in both the groups ( 41.3 11.6 minutes in the dcs group vs. 43.2 10.9 minutes in the control group , p = 0.371 ) . 
  demographic , stone and operative profile of the dcs * and control group dcs hemoglobin , s.cr  serum creatinine ; dm  diabetes mellitus , htn  hypertension , copd  chronic obstructive pulmonary disease . results of the postoperative outcome are shown in table 2 . in the postoperative period , the pain score at the 6 postoperative hour and the total analgesic requirement in the recovery room were significantly lower in the dcs group when compared to the control group ( 3.79 1.23 vs. 6.12 0.96 and 1.48 0.50 vs. 4.09 1.11 ; p < 0.05 , respectively ) . mean drop in hemoglobin was significantly lower in the dcs group than in the control group ( 1.05 0.68 vs. 1.30 0.58 gm / dl respectively , p < 0.05 ) . mean duration of postoperative hospital stay in the dcs group was 0.48 0.26 days while it was significantly higher in the control group ( 4.74 1.53 days , p < 0.01 ) . cases in the control group consumed significantly higher amounts of rescue analgesics ( 3.90 2.53 grams in the dcs group vs. 16.72 4.43 grams in the control group , p < 0.05 ) . postoperative outcome in the dcs and control group overall , postoperative complications occurred in 11 cases ( 19.6% ) in the dcs group , while its incidence was 47.4% in the control group ( p < 0.05 ) . nearly nine percent of the cases in the dcs group ( 5 out of 56 ) while 10.5% of the cases in the control group ( 6 out of 57 ) had fever in the postoperative period . one patient in the dcs group needed hospital stay for more than 24 hours for sirs . the need for blood transfusion was lower in the dcs group when compared to the control population ( 1.8% vs. 7% respectively , p = 0.36 ) . when peri - nephrostomy urine leak is taken in to consideration , the incidence of access tract site urine leakage was significantly lower in the dcs subgroup when compared to the controls ( 3.6% vs. 21.1% , p < 0.05 ) . the incidence of urinary tract infection and tract site abscess was 3.6% and 5.4% in the dcs group while it was 7% and 1.8% in the control group , respectively . two cases in the control group had pleural effusion for which chest - tube drainage was needed in one of the cases . none of the cases in both the groups had organ failure , visceral injury or mortality . two cases in the dcs group while 1 case in the control group had residual calculi , which were treated with eswl . relatively higher proportion of cases in the dcs group needed re - admission , however the difference was not statistically significant ( 7.1% vs. 1.8% ; p = 0.21 ) . three cases in the dcs group were re - admitted for tract site abscess while one had hematuria that resolved with conservative management . management of tract site abscess included incision and drainage of the tract , antibiotic course as per the culture report , with the need of a dj stent placement in one case . daily wound dressing was done at the local health care center and the tract healed in about 2 weeks . time to resume normal work was significantly lower in the dcs subgroup ( 8.05 3.05 days in the dcs group vs. 18.42 4.42 days in the control group ; p < 0.05 ) . these include observation for hematuria , indwelling nephrostomy tubes for hemostasis , intravenous antibiotics to prevent sepsis , serial hematological tests to look for bleeding , observation for medical and surgical complications . overall , the incidence of major complications following a pnl is low . in a study by tefekli and colleagues , the overall incidence of modified clavien grade 3 to 5 complication rate was 10.5% while it was even lower for a simple calculus ( isolated pelvic or calyceal calculi ) . in our study , this was due to the fact that it was a cohort of highly selected cases with renal stone disease . the potential advantages of day care pnl include quicker convalescence , decreased pain due to lack of nephrostomy tubes , lower risk of hospital acquired infections and significant cost savings . ever since its first description by preminger in 1986 , ambulatory day care pnl is still rarely performed by endourologists worldwide . however , with greater experience in the field of pnl , it is apparent that a subset of patients may be treated on a day care basis . as seen in our study , 90.2% of the cases who were initially randomized to the dcs group could be managed under the dcs protocol . nephrostomy tubes used for providing unobstructed urinary drainage and tract site hemostasis have been one of the factors for prolonged hospitalization . we observed that the mean drop in hemoglobin was significantly lower in dcs group when compared to the control group ( 1.05 0.68 vs. 1.30 0.58 gm / dl , p = 0.039 ) . also , the need for blood transfusion was lower in the dcs group ( 1.8% vs. 7% , p = 0.36 ) . sufficient evidence exists to suggest tubeless pnl to be equivalent or even superior to standard pnl for a select group of patients . various adjuncts have been tried to enhance hemostasis of the percutaneous tract , one of which is insertion/ instillation of hemostatic agents into the tract including oxidized cellulose , gelatin sponge , gelatin granules plus thrombin and fibrin glue [ 811 ] . singh and colleagues found significantly less pain , lower analgesia requirement , and shorter hospital stay with lower wound soakage / discomfort in the gelatin - assisted tubeless pnl group versus the tubeless pnl without gelatin packing . nagele and colleagues found that closing the tract of the mini - pnl with gelatin matrix hemostatic sealant is a safe and fast alternative and provides the option of discharging the patient in good condition without the commonly used nephrostomy tube . kumar and colleagues reported that the use of systemic tranexamic acid in percutaneous nephrolithotomy is safe , and is associated with reduced blood loss and lower complication rates . however systemic tranexamic acid has got its own side effects and is contraindicated in patients more than 50 years of age , in cases of chronic renal failure , coronary artery disease , subarachnoid hemorrhage and in cases of active intravascular clotting . in such cases low dose ( 250 mg ) tranexamic acid can be used locally as its systemic toxicity would be less . moreover , using tranexamic acid along with noradrenaline would further reduce its systemic absorption , hence contributing to lower systemic side effects . emara and colleagues showed a significant reduction in blood loss by using the topical tranexamic acid when compared to the control group in pelvic hemiarthroplasty . the potential of norepinephrine to reduce intraoperative blood loss has been explored in other surgeries too . in a study by wuethrich and colleagues , continuous intraoperative norepinephrine infusion was shown to significantly reduce the need for blood transfusion in open radical cystectomy . we made a composite tract sealant using a combination of a strip of oxidized regenerated cellulose wrapped over gelatin sponge soaked in 250 mg of tranexamic acid and 5 ml of 1:1000 dilution of noradrenaline and 76% solution of trazograf . the contrast material helped to place the seal under fluoroscopic guidance outside the pelvicalyceal system into the pnl tract , noradrenaline helped by constricting smaller bleeding vessels , tranexamic acid helped by acting as an anti - fibrinolytic agent , while the gelatin sponge and oxidized regenerated cellulose strips helped by accelerating hemostasis by formation of a platelet plug . since , each component has already been used in the human body , there were no concerns raised about their use in the composite seals . a reduction in the transfusion rate would not only decrease the hospital stay , but would also reduce the incidence of transfusion - mediated reactions in post - pnl cases . therefore , there was no increment in the cost of surgery from the patients perspective . it was less than that reported in previous studies . in a series of 10 cases of ambulatory day care pnl , singh et al . reported the average operative time of 48.4 minutes , while it was 83.5 minutes in a study by shahrour and colleagues [ 15 , 16 ] . furthermore , we calculated the time interval starting from the skin puncture and ending with the skin suture . also , instead of sequential dilatation , we dilated the tract in three steps , which helped in reducing the operative time with no significant adverse consequences . the stone clearance rate in our study was 96.4% in the dcs group and 98.2% in the control group , which was higher than in the studies by giusti and shoma ( 95.4 and 92% respectively ) [ 17 , 18 ] . the higher incidence of stone clearance may be explained by the favorable stone and renal anatomy while preoperatively selecting patients for the study . we observed that the mean pain score assessed by the vnrs score at the 6 postoperative hour and total analgesic requirement in the recovery room were significantly lower in the dcs group when compared to the control group ( 3.79 1.23 vs. 6.12 0.96 ; p < 0.05 and 1.48 0.50 vs. 4.09 1.11 ; p < 0.05 , respectively ) . the pain score in the dcs group was comparable to the study by shoma et al . undoubtedly , tubeless pnl in appropriately selected patients has been shown to be associated with significantly reduced postoperative pain and analgesic requirement [ 17 , 18 ] . instead of placing an antegrade dj stent , we retained the ureteric access catheter that was removed at the time of discharge . this practice provided the benefits of tubeless pnl along with avoidance of additional cystoscopic procedure required for stent removal . we found that the mean duration of postoperative hospital stay in the dcs group was 0.48 0.26 days , while it was significantly higher in the control group ( 4.74 1.53 days , p < 0.01 ) . in our study , 90.2% ( 55/61 ) of the cases who were initially randomized to the dcs group were discharged within 24-hours of the surgery . preoperatively selected cases could successfully complete the study protocol and were discharged within 24 hours of surgery . alyami et al . reported that 66% of their cases could be safely discharged after an overnight stay . in the study by tabey and colleagues , 71.4% of the cases could be safely discharged from the hospital within 24-hours postoperatively . relatively higher proportion of cases could be discharged within 24 hours of surgery in our series . possible reasons could be shorter operative time thereby decreasing the duration of anesthetic drug exposure , use of pnl - tract seals that could be the possible reason for lower postoperative blood loss , pain and access site morbidity in the form of urine leakage , liberal use of analgesics with avoidance of opioids in the postoperative period for pain control and avoidance of stent placement while retaining the ureteric catheter . the ureteric catheter was easily removed in the postoperative period once the urine was clear . this helped to prevent stent - related symptoms that could result in postoperative discomfort resulting in prolongation of hospital stay as well as avoided additional cystoscopic procedures for stent removal . time to resume normal work was significantly lower in the dcs subgroup ( 8.05 3.05 days in the dcs group vs. 18.42 4.42 days in the control group ; p < 0.001 ) suggesting that the day care protocol could decrease the number of leaves taken from work . however , the re - admission rates were relatively higher ( although not statistically significant ) in the dcs group thereby suggesting that these patients are vulnerable for certain postoperative complications which they must understand and comply with when given the instructions by the treating physician . day care protocol should be avoided in patients who do not have immediate access to a health care facility . in the review by choe and colleagues , it was found that the majority of the studies did not consistently result in a significant decline in postoperative blood loss and need of blood transfusion . one thing is clear that the use of hemostatic adjuncts do result in significantly decreased post - pnl morbidity . very few randomized and retrospective / prospective studies are available evaluating the efficacy of hemostatic adjuncts in tubeless pnl for reducing postoperative bleeding . we chose a combination of easily available cheaper agents to augment pnl tract hemostasis which resulted in a significantly lower postoperative pain score and a fall in hemoglobin allowing early discharge of patients from the hospital . limitations of our study include a small sample size and lack of critical cost - analysis from the patients perspective . implications of our study in the literature are that in carefully selected patients , the composite seal can serve as a useful adjunct for tubeless pnl . the major advantage is the low cost involved in the preparation of this composite seal compared to commercially available sealants like tissel and floseal . it resulted in significant reduction of blood loss and analgesic requirement with significantly reduced hospital stay , nephrostomy tube site morbidity and time required to resume normal activity when compared to standard pnl . however , patients must be compliant with instructions and should have access to a health care facility , as few of them may need re - admission . all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 helsinki declaration and its later amendments or comparable ethical standards . informed consent : informed consent was obtained from all individual participants included in the study .
introductionto compare the outcomes of tubeless day care pnl using hemostatic seal in the access tract versus standard pnl.material and methodsit was a prospective randomized controlled study . 
 cases were randomized to either the day care group with hemostatic seal ( dcs ) or the control group where patients were admitted and a nephrostomy tube was placed at the conclusion of surgery.resultsa total of 180 cases were screened and out of these , 113 were included in the final analysis . 
 the stone clearance rates were comparable in both the groups . 
 the mean drop in hemoglobin was significantly lower in dcs group than the control group ( 1.05 0.68 vs. 1.30 0.58 gm / dl , p = 0.038).mean postoperative pain score , analgesic requirement ( paracetamol ) and duration of hospital stay were also significantly lower in the dcs group ( 3.79 1.23 vs. 6.12 0.96 , 1.48 0.50 vs. 4.09 1.11 grams and 0.48 0.26 vs. 4.74 1.53 days respectively ; p < 0.05 ) . 
 the incidence of urine leakage through the access tract site was significantly lower in the dcs subgroup when compared to the controls ( 3.6% vs. 21.1% , p < 0.05 ) . 
 cases in the dcs group resumed their normal activities in a significantly shorter time ( 8.05 3.05 vs.18.42 4.42 days ; p < 0.05 ) . 
 higher proportion of cases in the dcs group got re - admitted , although it was not a statistically significant number ( 7.1% vs. 1.8% ; p = 0.21).conclusionstubeless day care pnl with composite hemostatic tract seal is considered safe . 
 it resulted in a significant reduction of blood loss and analgesic requirement with significantly reduced hospital stay , nephrostomy tube site morbidity and time required to resume normal activity when compared to the standard pnl . 
 however , patients must be compliant with the given instructions and should have access to a health care facility , as few of them may need re - admission .