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IRCT2017062334639N1 IRCT 2017-07-05 Vice chancellor for research, Shahid Beheshti university of medical sciences Mini laparoscopy for ureteral stone Comparing standard laparoscopy and mini laparoscopy for management of ureteral stone 2017-07-01 anticipated 40 Complete https://irct.ir/trial/26429 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other. 2 ureteral stone. Intervention 1: Intervention: Mini laparoscopic ureterolithotomy will be done for patients with upper ureteral stone. Mini laparoscopic ureterolithotomy (MLU) defines as one 5-mm trocar for a 5-mm laparoscope and two or three 3-mm ports. Transperitoneal approach will be used for all patients. Colon will be mobilized medially and after releasing the ureter, incision will be made longitudinally over the stone site on the ureteral wall and stone will be pulled out. After placing a jj stent, ureteral opening will be repaired with separate stiches and stone will extract from camera port site. Intervention 2: Control: standard laparoscopic ureterolithotomy (SLU) includes using one 12-mm port for a 10-mm laparoscope and three 5-mm ports. Colon will be mobilized medially and after releasing the ureter, incision will be made longitudinally over the stone site on the ureteral wall and stone will be pulled out. After placing a jj stent, ureteral opening will be repaired with separate stiches and stone will extract from camera port site.
public Sepehr Hamedanchi
Labbafinejhad hospital, 9th Boostan, Pasdaran street
Tehran Iran (Islamic Republic of) +98 21 2254 8886 sepehrhamedanchi@sbmu.ac.ir Shahid Beheshti university of medical siences scientific Sepehr Hamedanchi
Labbafinejhad hospital, 9th Boostan, Pasdaran street
Tehran Iran (Islamic Republic of) +98 21 2254 8886 sepehrhamedanchi@sbmu.ac.ir Shahid Beheshti university of medical sciences Iran (Islamic Republic of) Main inclusion criteria: ureteral stones larger than 10 mm which failed to manage with medical expulsive therapy, ureteroscopy or shock wave lithotripsy Main exclusion criteria: patients with very high risk for general anaesthesia; coagulation disorders; stones at distal ureter; pyonephrosis; pregnant patients no limit no limit Both N20.1 caculus of ureter Treatment - Surgery Treatment - Surgery Intervention: Mini laparoscopic ureterolithotomy will be done for patients with upper ureteral stone. Mini laparoscopic ureterolithotomy (MLU) defines as one 5-mm trocar for a 5-mm laparoscope and two or three 3-mm ports. Transperitoneal approach will be used for all patients. Colon will be mobilized medially and after releasing the ureter, incision will be made longitudinally over the stone site on the ureteral wall and stone will be pulled out. After placing a jj stent, ureteral opening will be repaired with separate stiches and stone will extract from camera port site Control: standard laparoscopic ureterolithotomy (SLU) includes using one 12-mm port for a 10-mm laparoscope and three 5-mm ports. Colon will be mobilized medially and after releasing the ureter, incision will be made longitudinally over the stone site on the ureteral wall and stone will be pulled out. After placing a jj stent, ureteral opening will be repaired with separate stiches and stone will extract from camera port site Cosmesis. Timepoint: 3 months after surgery. Method of measurement: Vancouver scar scale. Pain. Timepoint: 6, 12 ,24, 48, 120 hours after surgery. Method of measurement: by the patient using Numeric pain rating scale. Rehabilitation period. Timepoint: days to resume normal activity. Method of measurement: ask from patient. Complications. Timepoint: 3 month. Method of measurement: lab and imaging. Operating time. Timepoint: during surgery. Method of measurement: clock. Bleeding. Timepoint: 12 hours after surgery. Method of measurement: Hb level. Vice chancellor for research, Shahid Beheshti university of medical sciences Approved 2017-01-20 Ethics committee of Shahid Beheshti medical university Shahid Bheshti university of medical sciences, Yaman street, Chamran highway Tehran Iran (Islamic Republic of)