PURPOSE: The object of this study was to evaluate technique using the ultrasonically activated scalpel as an alternative to closed hemorrhoidectomy in an unbiased evaluation of this new technology. METHODS:Thirty patients with Grade 2 or 3 symptomatic hemorrhoids were prospectively randomized to undergo closed hemorrhoidectomy assisted by electrocautery or hemorrhoidectomy with the ultrasonically activated scalpel, i.e., the Harmonic Scalpel. We evaluated the difference between techniques in operative time, postoperative pain, incontinence, and quality of life (using the Short Form-36 survey), as well as complications. RESULTS:Mean operative time for closed hemorrhoidectomy with electrocautery was 35.7 +/- 3 minutes; for Harmonic Scalpel patients, it was 31.7 +/- 2 minutes (P < 0.37). There was no statistical difference in operative time for two- or three-column hemorrhoidectomy. There was no significant difference in pain measurements reported on Day 1 (5.8 +/- 0.4 for electrocautery and 5.6 +/- 0.6 for Harmonic Scalpel, P < 0.82). On postoperative Day 7, the difference in pain between groups approached significance, with pain reported as 3.7 +/- 0.3 for electrocautery and 5.1 +/- 0.7 for Harmonic Scalpel(R) (P < 0.06). At six weeks, both groups were pain free. There was a significant decrease in pain between postoperative Days 1 and 7 in the electrocautery patients that was not seen in the Harmonic Scalpel patients. Incontinence measured preoperatively, at postoperative Day 7, and at postoperative Week 6 was similar for both groups and reflected occasional incontinence of gas. When the various items of the Short Form-36 survey were compared, there was no significant difference between posttreatment and preoperative values. There was no difference in the number of complications between patient groups. CONCLUSION: Although the Harmonic Scalpel is an effective tool in the treatment of hemorrhoidal disease, we found no specific advantage in postoperative pain, fecal incontinence, operative time, quality of life, or complications compared with traditional closed hemorrhoidectomy.
RCT Entities:
PURPOSE: The object of this study was to evaluate technique using the ultrasonically activated scalpel as an alternative to closed hemorrhoidectomy in an unbiased evaluation of this new technology. METHODS: Thirty patients with Grade 2 or 3 symptomatic hemorrhoids were prospectively randomized to undergo closed hemorrhoidectomy assisted by electrocautery or hemorrhoidectomy with the ultrasonically activated scalpel, i.e., the Harmonic Scalpel. We evaluated the difference between techniques in operative time, postoperative pain, incontinence, and quality of life (using the Short Form-36 survey), as well as complications. RESULTS: Mean operative time for closed hemorrhoidectomy with electrocautery was 35.7 +/- 3 minutes; for Harmonic Scalpel patients, it was 31.7 +/- 2 minutes (P < 0.37). There was no statistical difference in operative time for two- or three-column hemorrhoidectomy. There was no significant difference in pain measurements reported on Day 1 (5.8 +/- 0.4 for electrocautery and 5.6 +/- 0.6 for Harmonic Scalpel, P < 0.82). On postoperative Day 7, the difference in pain between groups approached significance, with pain reported as 3.7 +/- 0.3 for electrocautery and 5.1 +/- 0.7 for Harmonic Scalpel(R) (P < 0.06). At six weeks, both groups were pain free. There was a significant decrease in pain between postoperative Days 1 and 7 in the electrocautery patients that was not seen in the Harmonic Scalpel patients. Incontinence measured preoperatively, at postoperative Day 7, and at postoperative Week 6 was similar for both groups and reflected occasional incontinence of gas. When the various items of the Short Form-36 survey were compared, there was no significant difference between posttreatment and preoperative values. There was no difference in the number of complications between patient groups. CONCLUSION: Although the Harmonic Scalpel is an effective tool in the treatment of hemorrhoidal disease, we found no specific advantage in postoperative pain, fecal incontinence, operative time, quality of life, or complications compared with traditional closed hemorrhoidectomy.
Authors: Liam A Haveran; Paul R Sturrock; Mark Y Sun; Janet McDade; Sudershan Singla; Craig A Paterson; Timothy C Counihan Journal: Int J Colorectal Dis Date: 2006-11-22 Impact factor: 2.571
Authors: Moonkyung Cho Schubert; Subbaramiah Sridhar; Robert R Schade; Steven D Wexner Journal: World J Gastroenterol Date: 2009-07-14 Impact factor: 5.742