Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy

NCT07587892 | Active Not Recruiting

• 1 other identifier: SKE00101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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; Hemorrhoidectomy; Hemorrhoid Pain

Keywords

Hemorrhoids; Hemorrhoidectomy; Argon plasma coagulation; Grade III hemorrhoids; Grade IV hemorrhoids; Postoperative pain; Proctology

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity before taking analgesics on postoperative day 4

  Postoperative pain intensity will be assessed using the visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain). The primary analysis will compare the VAS pain scores on postoperative day 4, before taking analgesics;

  Assessment on the fourth postoperative day

Secondary Outcomes (14)

• Postoperative pain intensity on day 14

  Assessment on the postoperative day 14

• Postoperative pain intensity after the first defecation

  At the day of the first defecation during first week after surgery

• Intraoperative bleeding

  During surgery

• Postoperative bleeding

  From surgery through postoperative day 28

• Rate of Participants with postoperative burning sensation and itching

  From surgery through postoperative day 28

Study Arms (2)

argon plasma coagulation- APC-arm

EXPERIMENTAL

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 APC arm will be 50 participants.Patients aged ≥18 years with symptomatic grade III -IV hemorrhoids refractory to conservative treatment will eligible for inclusion. Exclusion criteria are: * external hemorrhoids thrombosis * patients with grade I-II hemorrhoids * acute and chronic anal fissures * requiring combined interventions * previous surgical interventions for hemorrhoids like a rubber band ligation * sclerotherapy or laser hemorrhoidplasty (LHP) * pregnancy * Any known anorectal malignancy or suspicion of malignancy * Significant systemic diseases (severe cardiovascular disease, severe hepatic dysfunction)

Procedure: open hemorrhoidectomy using argon plasma coagulation

open hemorrhoidectomy using monopolar coagulation

ACTIVE COMPARATOR

In MC arm will be 50 participants

Procedure: open hemorrhoidectomy using momopolar coagulation

Interventions

open hemorrhoidectomy using argon plasma coagulation PROCEDURE

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.

argon plasma coagulation- APC-arm

open hemorrhoidectomy using momopolar coagulation PROCEDURE

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

open hemorrhoidectomy using monopolar coagulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• external hemorrhoids thrombosis
• patients with grade I-II hemorrhoids
• acute and chronic anal fissures
• requiring combined interventions
• previous surgical interventions for hemorrhoids like a rubber band ligation
• sclerotherapy or laser hemorrhoidplasty (LHP)
• pregnancy
• Any known anorectal malignancy or suspicion of malignancy
• Significant systemic diseases (severe cardiovascular disease, severe hepatic dysfunction)

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

University Clinical Hospital №4, Sechenov University, Moscow, Russia

Moscow, Moscow, 101000, Russia

Location

Related Publications (2)

• Efetov S, Otabekov A, Koziy A. Seamless open excisional haemorrhoidectomy-Six faces of surgical technique: A Video Vignette. Colorectal Dis. 2024 Jul;26(7):1478-1479. doi: 10.1111/codi.17009. Epub 2024 May 21. No abstract available.

  PMID: 38773684 BACKGROUND

• Efetov S, Rebrova A, Volgin M, Koziy AY, Zubayraeva A. Argon plasma coagulation in two-step procedure for surgical treatment of huge circular four-stage haemorrhoids - A video vignette. Colorectal Dis. 2025 Sep;27(9):e70237. doi: 10.1111/codi.70237. No abstract available.

  PMID: 40990073 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sergey K Efetov, MD, PhD

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Efetov Sergey

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: May 14, 2026
• Study Start: August 1, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

RU (1)