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Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy

Study acronym: ARGO
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Secondary endpoints revised (14)v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This prospective single-center randomized clinical trial evaluates whether the use of argon plasma coagulation (APC) during open excisional hemorrhoidectomy reduces postoperative pain and perioperative morbidity compared with conventional monopolar coagulation in adults with symptomatic grade III-IV hemorrhoids requiring surgical treatment. A total of 100 participants will be randomized in a 1:1 ratio to open hemorrhoidectomy performed with APC or open hemorrhoidectomy performed with monopolar coagulation. In two arms, the severity of pain will be assessed from day 1 to day 7 postoperatively, both before and after taking analgesics. Additional assessments will be conducted on days 14 and 28 post-surgery, as well as during the first and second defecation using a visual analog scale (VAS). Early postoperative complications, including intraoperative and postoperative bleeding, burning sensation and itching will be evaluated. Long-term complications such as anal canal stenosis, perianal scar deformation, and disease recurrence will be assessed six months after surgery using digital examination performed by consultant proctologist. The goal of this clinical trial is to discover the safety and efficacy of open excisional hemorrhoidectomy for hemorrhoids III-IV grade using argon plasma coagulation.
Trial Details
NCT Number NCT07587892
Lead Sponsor I.M. Sechenov First Moscow State Medical University
Conditions
(from sponsor)
Hemorrhoidal Disease, Hemorrhoid Pain, Hemorrhoidectomy
Related terms Hemorrhoids, Postoperative Pain
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov