Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy

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.

Conditions

• Hemorrhoidal Disease
• Hemorrhoid Pain
• Hemorrhoidectomy

Interventions

PROCEDURE

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.

PROCEDURE

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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University

  lead OTHER

Principal Investigators

• Sergey K Efetov, MD, PhD · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2026-03-01

Completion

2026-10-01

Countries

• Russia

Study Locations