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IRCT201104272982N2 IRCT 2011-10-14 Tehran University of Medical Sciences Comparison of intrahemorrhoidal coagulation using 980 nanometer diode LASER with Milligan Morgan hemorrhoidectomy Comparison of intrahemorrhoidal coagulation using 980 nanometer diode LASER with Milligan Morgan hemorrhoidectomy in Shariati hospital in 2010-2012 2011-03-21 anticipated 60 Complete https://irct.ir/trial/2897 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A haemorrhoids. Intervention 1: control group: patients undergo general anesthesia with defined protocol and would be placed in lithotomy position. After anoscopy and determining abnormal hemorrhoidal pads, they are removed by eliptical incision from anal verge to anorectal ring. Then the base is suture ligated and wound is left open. Patient controlled analgesia device (PCAD)- contains 30 mg morphine sulfate in 30 cc normal saline - is connected in recovery unit and a loading dose is injected. Bolus volume and lock out time would be 1 cc (1 mg morphine) and 8 minutes respectively. Patient are educated before the procedure on how to work with PCAD. One dose of intravenous ceftriaxone and metronidazole given before and continues till 24 hours after surgery. Intervention 2: intervention group: patients undergo general anesthesia with defined protocol and would be placed in lithotomy position. After anoscopy and determining abnormal hemorrhoidal pads, each one would be coagulated using 980 nanometer diode LASER with 15 watts energy and 3 seconds pulses fired in parallel lines, 5 mm apart. No resection is done. Patient controlled analgesia device (PCAD)- contains 30 mg morphine sulfate in 30 cc normal saline - is connected in recovery unit and a loading dose is injected. Bolus volume and lock out time would be 1 cc (1 mg morphine) and 8 minutes respectively. Patient are educated before the procedure on how to work with PCAD. One dose of intravenous ceftriaxone and metronidazole given before and continues till 24 hours after surgery.
public Zhamak Khorgami
Shariati Hospital, North Kargar Avenue
Tehran Iran (Islamic Republic of) +98 21 8490 2450 khorgami@gmail.com Tehran University of Medical Sciences - Shariati Hospital scientific Zhamak Khorgami
Shariati Hospital, North Kargar Avenue
Tehran Iran (Islamic Republic of) +98 21884902450 khorgami@gmail.com Tehran University of Medical Sciences - Shariati hospital Iran (Islamic Republic of) Inclusion Criteria: those with symptomatic hemorrhoids (mainly grade II and III) refractory to medical treatments Exclusion Criteria: extensive circumferencial grade 4 hemorrhoids, drug-addicted patients, other simultaneous anorectal problems (e.g. fissure) 18 years 80 years Both I84.9 Unspecified haemorrhoids without complication Treatment - Surgery Treatment - Surgery control group: patients undergo general anesthesia with defined protocol and would be placed in lithotomy position. After anoscopy and determining abnormal hemorrhoidal pads, they are removed by eliptical incision from anal verge to anorectal ring. Then the base is suture ligated and wound is left open. Patient controlled analgesia device (PCAD)- contains 30 mg morphine sulfate in 30 cc normal saline - is connected in recovery unit and a loading dose is injected. Bolus volume and lock out time would be 1 cc (1 mg morphine) and 8 minutes respectively. Patient are educated before the procedure on how to work with PCAD. One dose of intravenous ceftriaxone and metronidazole given before and continues till 24 hours after surgery. intervention group: patients undergo general anesthesia with defined protocol and would be placed in lithotomy position. After anoscopy and determining abnormal hemorrhoidal pads, each one would be coagulated using 980 nanometer diode LASER with 15 watts energy and 3 seconds pulses fired in parallel lines, 5 mm apart. No resection is done. Patient controlled analgesia device (PCAD)- contains 30 mg morphine sulfate in 30 cc normal saline - is connected in recovery unit and a loading dose is injected. Bolus volume and lock out time would be 1 cc (1 mg morphine) and 8 minutes respectively. Patient are educated before the procedure on how to work with PCAD. One dose of intravenous ceftriaxone and metronidazole given before and continues till 24 hours after surgery. Postoperative narcotic usage. Timepoint: continuous till time of discharge. Method of measurement: Patient controlled analgesia device. Postoperative urinary retention. Timepoint: At the time of discharge. Method of measurement: History taking. Postoperative bleeding. Timepoint: At the time of discharge. Method of measurement: History taking and clinical records. Operation time. Timepoint: At the end of surgery. Method of measurement: from start (after prep and drep) till end (before dressing). Bleeding during surgery. Timepoint: At the end of surgery. Method of measurement: based on the number of wet gauzes. Postoperative pain. Timepoint: 6 hour interval. Method of measurement: Visual analogue scale. Hospital stay. Timepoint: At the time of discharge. Method of measurement: based on medical reocords. Recovery of treated hemorrhoids. Timepoint: 3 months after surgery. Method of measurement: Physical examination. Surgical site infection. Timepoint: At the time of discharge and one week later. Method of measurement: Physical examination. Recovery of symptoms. Timepoint: 3 months after surgery. Method of measurement: History taking. Tehran University of Medical Sciences Approved 2011-01-12 Tehran University of Medical Sciences Central building, Qhods avenue Tehran Iran (Islamic Republic of)