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IRCT20170417033489N6 IRCT 2020-12-23 Mashhad University of Medical Sciences Saphenous Vein Graft for Treatment of Penile Curvature Saphenous Vein Graft for Treatment of Peyronie’s Disease, a Comparison Between Single and Multiple Graft Reconstruction 2011-10-01 anticipated 52 Complete https://irct.ir/trial/51769 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization, after assessing entrance eligibility, we divided every second patient into two groups. N/A Peyronie's disease. Intervention 1: Intervention group: Grafting through a double-Y incision and a single saphenous graft placement. We randomly divided 48 patients into two groups. A single surgical team performed all the surgeries. For both groups, saphenous graft harvested from the thigh's anterior surface, then a circumcision incision performed, and penile skin degloved, then a complete or near-complete penile disassembly was performed (neurovascular bundle and corpus spongiosum). For the first group, one double-Y incision was made on tunica albuginea, and a saphenous graft placed within the incision. Intervention 2: Intervention group: Grafting through two parallel incisions and two pieces of saphenous vein grafts that were placed in the incisions. Two transverse incisions on tunica albuginea were made, and two relatively smaller saphenous grafts were placed. Then the tunica albuginea sutured via 4/0 polydioxanone suture. Yes - There is a plan to make this available What will be shared: Information related to the International index of erectile function (IIEF) and the presence of common complications like sacculation, penile shortening, post-operation infection, and penile hypoesthesia will be shared. When: After publication To whom: Scientific and university researchers Conditions: Scientific and university researchers are allowed to ask for the anonymous data of the study. Raw data are provided by the corresponding scientist. Where to obtain: Salman Soltani (MD), Postal address: Urology department, Imam Reza hospital, Shariati Square, Mashhad, Iran. Postal code/ P.O. Box: 9137913316 Telephone number: +9851 38022553 Email Address: SoltaniS@mums.ac.ir How to obtain: One week after submitting the request. Comments:
public Kamyar Tavakkoli Tabassi
Shariati Sq
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3858 3885 tavakolik@mums.ac.ir Mashhad University of Medical Sciences scientific Salman Soltani
Shariati Sq.
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3858 3885 soltanis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) severe penile angulation (>60˚) penile length less than 13 centimeters hinge- or hourglass-deformity complex curvature (multiple axis) patient’s consent to cooperate in this study no limit no limit Male erectile dysfunction N48.6 Induration penis plastica Treatment - Surgery Treatment - Surgery Intervention group: Grafting through a double-Y incision and a single saphenous graft placement. We randomly divided 48 patients into two groups. A single surgical team performed all the surgeries. For both groups, saphenous graft harvested from the thigh's anterior surface, then a circumcision incision performed, and penile skin degloved, then a complete or near-complete penile disassembly was performed (neurovascular bundle and corpus spongiosum). For the first group, one double-Y incision was made on tunica albuginea, and a saphenous graft placed within the incision. Intervention group: Grafting through two parallel incisions and two pieces of saphenous vein grafts that were placed in the incisions. Two transverse incisions on tunica albuginea were made, and two relatively smaller saphenous grafts were placed. Then the tunica albuginea sutured via 4/0 polydioxanone suture. Erectile dysfunction. Timepoint: 18 months post operative. Method of measurement: International index of erectile function. Mashhad University of Medical Sciences Approved 2017-02-19 Ethics committee of Mashhad University of Medical Sciences Azadi sq, Ferdowsi University Mashhad Razavi Khorasan Iran (Islamic Republic of)