European Journal of Cardiovascular Medicine

In 1976, Fernstrom and Johansson first described percutaneous nephrolithotomy (PCNL) which is the universally accepted modality in the treatment of large and complex renal stones. Over a period of time, various changes have occurred in the techniques of PCNL.PCNL was associated with morbidities such as bleeding, pyrexia, incomplete stone removal, pleural injury, and adjacent organ injury.¹After completion of stone removal, usually, a nephrostomy tube is placed which helps in tamponade of bleeding, drainage of urine, tract recovery, and a guide for second look nephroscopy if needed. In various studies, the usage of small caliber nephrostomy tubes were found to be equivalent to large nephrostomy tubes. Apart from the above-mentioned benefits of placing a nephrostomy tube, it often increases early postoperative morbidity like pain and prolonged hospital stay.²

Technical evolutions in optics of nephroscope and lithotripters have decreased morbidity after PCNL considerably. The presence and removal of nephrostomy are associated with morbidities such as infection, pain, urine leak, bleeding, and prolonged hospitalization. Bellman et al in 1997 first described “tubeless” PCNL which involved placement of a ureteric stent without nephrostomy. The presence of a double-J stent in tubeless PCNL may be associated with stent-related problems such as frequency, urgency, nocturia, pain, and hematuria. However, the morbidity of the nephrostomy tube after PCNL is much higher compared to the stent-related symptoms of tubeless PCNL which can be managed by medical therapy.³

The estimated prevalence of renal stone disease is 1% to 5%. Soucie et al proposed that the prevalence of stone disease is 10% in males and 4% in females. Whites are commonly affected than Asians and Afro-Americans. The incidence of stone disease is highest in fourth to sixth decades. Hot arid climate, obesity and sedentary lifestyle predispose to stone formation. Hippocrates had described the renal colic symptoms as follows: “An acute pain is felt in the kidney, the loins, the flank and the testis of the affected side. The patient passes urine frequently. Gradually the urine is suppressed. With the urine, the sand is passed. “There had been a vast progress in the evaluation, imaging and management of this disease.⁴ Initially the management procedures had significant morbidity and sometimes mortality. With advances in surgical techniques, the mortality has reduced considerably. PCNL had improved reasonably over the last twenty years as a result of technical advancements and perfections in surgical skill for doing PCNL. A milestone in the history of PCNL is the introduction and development of the ‘tubeless PCNL’ which isnow been proposed to have a comparatively lesser morbidity rates than the standard procedure. The purpose of this study is to analyse the evidence -based literature regarding the ‘nephrostomy-free’ or ‘tubeless’ PCNL and to assess the safety, efficacy, possibility, and benefits of tubeless PCNL over standard PCNL. Purpose was to study outcomes and complications of tubeless PCNL and to systematically analyse the safety and efficacy of the tubeless PCNL.⁵

This was a prospective comparative study, conducted in the Department of Urology, Super Speciality Hospital, Government Medical College, Kadapa and Department of Urology, Government General Hospital, Kurnool Medical College, Kurnool, Andhra Pradesh a period of 12 months from June 2023 to May 2024. A total number of 216 cases of tubeless PCNL was studied data collected and results analysed. Sample size estimated based on prevalence of the operable renal calculi (using formula S =4pq/l2) Results of study group were compared with other group of traditional PCNL with 232 patients.

Inclusion criteria

Patients with renal and/or upper uretric calculi of greater than 1.5cm, negative urine culture and no coagulopathy.

Exclusion criteria

Those patients with solitary kidney, more than 2 percutaneous accesses, significant perforation of the collecting system and significant intraoperative bleeding and patients with raised creatinine, patients with ectopic, malrotated and fused kidneys.

Pre-operative assessment done with indication for surgery and patient's complete history and physical examination. Important laboratory parameters such as urine analysis and culture / sensitivity, haemoglobin, electrolytes and serum urea/creatinine, coagulation profile were checked before the surgery. Hb%, serum electrolytes, creatinine and urea repeated after surgery also. Pre-operative intavenous urography (IVU), plain CT KUB, early morning X-ray KUB on the day of surgery was performed in all cases. Ultrasound and/or X-ray KUB were repeated 24 hours after surgery. Mean stone burden was calculated in each case by the horizontal and vertical dimensions of the stone, as seen on IVU.

The surgical technique was carried out under general anaesthesia. A 5F transurethral ureteric catheter was placed. Percutaneous access was created in all cases under fluoroscopic guidance with the patient in prone position. The nephrostomy tract was dilated with metal dilators and Amplatz sheath was left in situ. A 26 Fr angled Storznephroscope was used and calculus disintegration was performed using lithoclast.

On completion of the procedure, DJ stent was placed and Amplatz sheath was removed. The wound was stitched with Prolene 4/0 mattress suture. A Foley's catheter was left in the bladder at the end of the procedure, for all study cases tubeless methodology followed i.e no nephrostomy. After surgery fluoroscopy and endoscopy were used to assess stone free status.

Patients data such as age, stone size, stone site, type of puncture, duration of surgery, hemoglobin, complication rate, analgesic need, type of analgesic, dose of analgesic, duration of hospitalization and total cost of the procedure were noted.

Statistical Analysis:

Collected data entered in to excel spread sheet and results analysed. The data was expressed in terms of Mean ± standard deviation. The intergroup comparison done by unpaired t-test. All statistical tests were conducted with a significance of level of p value < 0.05.

We evaluated the data of 448 cases undergoing PCNL in our hospital. We divided total cases in to 2 groups. There are 216 cases in group A who underwent tubeless PCNL and 232 patents in group B of traditional PCNL. Both groups has similar demographics according to age sex and comorbidities. Among these 216 cases (group A) 140 were male and 76 female patients. Male to female ratio is 1.66:1. The average age was 44.6 years with arrange of 20 to 65 years. Where as in group B male to female ratio is 2.3:1 and average age is 48.8 years. Out of 216 cases 12.9% (28) have hypertension, 9.25% (20) have diabetes mellitus, 8 patient have COPDs, 4 patient had hypothyroidism and 4 patient was known CKD.

Mean stone burden in group A is 2.24 cms with the smallest stone of 1.5 cm to largest stone of size 3.2cms. In 58 (53.7%) cases lower calyceal puncture done, 56 (25.9%) patients underwent upper calyceal puncture and for 22 (20.3%) cases middle calyceal puncture done. Single tract access was successful in most of the cases.

In addition, complications included high fever (more than 38.5°C) in 2 patients and prolonged renal pain were observed in 4 patients (1.85%) of tubeless PCNL patients. In Group A, for 204 (94.4%) patients and in Group B, for 212(91.3%) patients complete stone clearance was achieved. In Group A, Four patients (1.85%) underwent ureteroscopy for distal ureteric stone. In group B, 8 cases (3.44%) underwent ureterorenoscopy.

Table 1: Comorbidities In Both Groups

Table 2: Perioperative Parameters In Both Groups

Table 3: Post Operative Issues

The concept of a tubeless technique represents a novel alternative in the search to miniaturize the procedure. Bellman et al. reported their initial experience with a series of 50 patients who underwent various percutaneous procedures.⁶ Later Limb and Bellman completed 112 successful tubeless procedures, representing almost one-third of all their percutaneous procedures. Their Prospective randomized studies designed to compare tubeless vs. mini vs. standard   the superiority of the tubeless PCNL.⁷

In Our present study, we compared the effectiveness an safety of Standard PCNL and tubeless PCNL for operative time, postoperative analgesia, hospital stay, and stone-free rate. In the present study, there was no statistically significant difference between both groups for the age and sex of patients, comorbidities, stone side and location, this minimized the effect of any of them on the outcomes of theprocedures.⁸ There was no significant difference in initial stone burden between tubed and tubeless groups. The mean operative time in our study was longer in the standard PCNL group than in the Tubeless PCNL group [for group A-56.4min for group B 81.8 min, respectively] this difference was statistically significant. Ni et al. reported that tubeless PCNL had a reduced operative time versus standard PCNL. For the blood transfusion rate, there was a no significant difference between the two groups in the present study.⁹

Blood transfusion rate for group A was 5.55%, and for group B was8.62%. In the study of Khairy Salem et al. there was no need for blood transfusion during or after the operation due to insignificant blood loss. In studies conducted by Gupta et al and Crook et al there is no statistically significant difference in blood transfusion rates between two groups i.e standard PCNL and tubeless PCNL. Hospital stay plays an important role in the evaluation of a technique, in our present study it was lower in Tubeless PCNL group [2.5 versus 4.8 days] than standard PCNL group; this difference was statistically significant. This result was similar to other published studies, such as in the study of Khairy Salem et al. in which the mean (range) hospital stay was 1.7 (1–4) days in the tubeless PCNL group and 2.8 (3–4) days in the Standard PCNL.¹⁰

Our findings demonstrated that tubeless PCNLs can be safely and effectively performed by an experienced endourologic team without limiting the number of eligible candidates by preoperative patient selection. Tubeless PCNL has an obvious advantage of significantly reduced postoperative pain, less analgesic requirement and shorter stays. Complications rate are less with tubeless PCNL and blood transfusion is less when compared with traditional PCNL. We believe that this study will contribute to the further popularization of the tubeless technique for the benefit of the patient, the medical team, and the health care system.

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