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IRCT20190624043991N15 IRCT 2021-07-28 Tehran University of Medical Sciences intrapritineal laparoscopic technique U-shape incision on on prostate capsule: New intrapritineal laparoscopic technique in simple prostatectomy. 2021-08-30 anticipated 10 Complete https://irct.ir/trial/57619 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: The present study is a single-blind randomized clinical trial. For randomization, the blanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined. According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the sealdenvelop online site, the generated sequence will be made available to a technician outside the research team. Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician. The patient is placed in (intrapritineal laparoscopic technique and U-shape incision on prostate capsule) or (Extraperitoneal laparoscopic technique and direct incision on the prostate capsule) group based on the randomly selected envelope, Blinding description: Patients who have given their consent to participate in the study will be treated with intrapritineal laparoscopic technique and U-shape incision on prostate capsule or Extraperitoneal laparoscopic technique and direct incision on the prostate capsule. The patient has no information about the surgical procedure and the design. N/A Intraperitoneal laparoscopic prostatectomy. Intervention 1: Intervention group: intrapritineal laparoscopic technique and U-shape incision on prostate capsule. During surgery; the patient is placed in the supine and intubated via a NG Tube. A Foley catheter 22f is inserted and the patient ‘s legs is placed at a 30-degree angle. Then a two-centimeter incision is made below the umbilicus, after that the peritoneum is opened and a 10 mm port is placed. The abdomen is then slowly filled with CO2 gas and two ports (5mm) are inserted in the umbilicus and the lateral of rectum under direct vision. In the next step, peritoneum is opened in the anterior part of the bladder and then the fourth port is placed in the suprapubic area for suctioning. The prostate capsule is opened transversely by a U-Shape incision at the distance of 0.5 cm from the bladder neck. At this time, the prostate adenoma is removed by suction and after inserting a 22f catheter, the capsule is sutured continuously. Patient is discharged with the catheter. One week later, the patient catheter is removed and 3 months later, IPSS and QMAX will measured again. Intervention 2: Intervention group: Extraperitoneal laparoscopic technique and direct incision on the prostate capsule. Yes - There is a plan to make this available What will be shared: demographic information anonymously When: one year after publication To whom: Researchers working in academia, physicians, surgeons and hospitals Conditions: Any analysis can be done with the consent of the main researcher Where to obtain: Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560 How to obtain: After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy. Comments: -
public Dr Akram Mirzaei
Urology Research Center, Sina Hospital , Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mirzaee.scholar@gmail.com Tehran University of Medical Sciences scientific Dr Mohammad Kazem Aghamir
Urology Research Center, Sina Hospital , Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mkaghamir@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with indications for prostate surgery infection bladder stones refractory retention non-response to medical treatment refractory hematuria Consent to participate in the study 18 years 70 years Male Abnormal rectal examination Active infection Severe heart or lung disease N42 Other and unspecified disorders of prostate Treatment - Surgery Treatment - Surgery Intervention group: intrapritineal laparoscopic technique and U-shape incision on prostate capsule. During surgery; the patient is placed in the supine and intubated via a NG Tube. A Foley catheter 22f is inserted and the patient ‘s legs is placed at a 30-degree angle. Then a two-centimeter incision is made below the umbilicus, after that the peritoneum is opened and a 10 mm port is placed. The abdomen is then slowly filled with CO2 gas and two ports (5mm) are inserted in the umbilicus and the lateral of rectum under direct vision. In the next step, peritoneum is opened in the anterior part of the bladder and then the fourth port is placed in the suprapubic area for suctioning. The prostate capsule is opened transversely by a U-Shape incision at the distance of 0.5 cm from the bladder neck. At this time, the prostate adenoma is removed by suction and after inserting a 22f catheter, the capsule is sutured continuously. Patient is discharged with the catheter. One week later, the patient catheter is removed and 3 months later, IPSS and QMAX will measured again. Intervention group: Extraperitoneal laparoscopic technique and direct incision on the prostate capsule Improving surgical technique. Timepoint: before and one month after surgery. Method of measurement: International prostatectomy score, maximum urinary flow rate and Prostate-Specific Antigen. Tehran University of Medical Sciences Approved 2020-06-28 Sina Hospital Research Ethics Committee Sina Hospital - Hassan Abad St. - Tehran - Iran تهران Tehran Iran (Islamic Republic of)