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Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy
Sponsor: I.M. Sechenov First Moscow State Medical University
Summary
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.
Official title: Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy for Grade III-IV Hemorrhoids
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-08-01
Completion Date
2026-10-01
Last Updated
2026-05-18
Healthy Volunteers
No
Interventions
open hemorrhoidectomy using argon plasma coagulation
After spinal anesthesia and positioning in lithotomy, the external component of the hemorrhoidal cushion will be grasped with Allis forceps, followed by its traction medially. Using argon plasma coagulation at the "cut" mode (power - 40W), an initial incision will be made in the peri-anal skin above the external hemorrhoidal node. Then, using "argon plasma coagulation" mode (power - 40W), the internal and external hemorrhoidal components will undergo dissection from the sphincters down to the vascular pedicle with preservation of mucocutaneous bridges. The vascular pedicle will be coagulated using the APC and cut. The tips of the surgery include non-suturing approach to vascular pedicle and non-touch technique to the preserved tissue for reducing pain severity. APC may allow to perform bloodless surgery due to welding of vessels.
open hemorrhoidectomy using momopolar coagulation
In the MC arm, participants will undergo the same open excisional hemorrhoidectomy technique, but tissue dissection and hemostasis will be performed using standard monopolar coagulation according to institutional routine practice
Locations (1)
University Clinical Hospital №4, Sechenov University, Moscow, Russia
Moscow, Moscow, Russia