Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy (ARGO)

Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy for Grade III-IV Hemorrhoids

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hemorrhoidal Disease; Hemorrhoidectomy; Hemorrhoid Pain
• Intervention / Treatment: Procedure: open hemorrhoidectomy using argon plasma coagulation; Procedure: open hemorrhoidectomy using momopolar coagulation

Detailed Description

Hemorrhoids are one of the most common proctological diseases, causing discomfort and pain for patients, while significantly impairing their quality of life. The main method of radical treatment for grade III-IV hemorrhoidal disease is open hemorrhoidectomy. The disadvantages of such procedure include intensive pain syndrome and prolonged wound healing duration. For improving surgical results, the investigators introduce argon plasma coagulation (APC), a technique not previously reported for open hemorrhoidectomy. Although argon plasma coagulation has not yet achieved widespread use in surgical treatment of hemorrhoidal disease, it is often used for reliable hemostasis, including parenchymatous organs. Argon plasma coagulation is extensively used in endoscopy, particularly in the treatment of Barrett's esophagus, with serious complications recorded in only 0.4% of cases and strictures in 1.7%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. The use of argon plasma coagulation minimizes coagulation-related tissue damage by delivering high-frequency current to the tissue through ionized argon in from a distance. In addition, APC can coagulate vessels up to 3-5 mm in diameter, which is greater than the typical calibre of hemorrhoidal vessels, potentially enabling secure hemostasis. This is a prospective single-centre randomized trial including two arms: the patients from main arm will undergo open hemorrhoidectomy using argon plasma coagulation (APC), while the control arm - will undergo open hemorrhoidectomy with usual monopolar coagulation (MC), in accordance with the inclusion and exclusion criteria. Using the Sample size calculator, a sample size of 50 participants per arm (total 100) provides >80% power with two-sided alpha level 0.05. 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. All potentially eligible participants will undergo screening before enrolment, including:

• Detailed medical history including current and past medications
• Physical examination including digital rectal examination and anoscopy/colonoscopy to confirm hemorrhoid grade
• Collection of demographic data (sex,age)
• Laboratory tests to rule out underlying conditions as per exclusion criteria. Participants meeting all inclusion and no exclusion criteria and who have provided informed consent will be officially enrolled. Randomization will occur on first-hospital day. Randomization is performing using the cluster method via the "Random Allocation Software" program.

All ethical principles outlined in the current version of the Declaration of Helsinki by the World Medical Association will be strictly adhered to. The study was approved by the institutional review board at Sechenov University №12-23. All participants of the trial could withdraw at any time without explanation.After randomization, study participants will be scheduled for open hemorrhoidectomy, performed using either argon plasma coagulation (APC) or standard monopolar coagulation, according to their assigned study arm. The internal and external hemorrhoidal components will undergo dissection from the sphincters down to the vascular pedicle with preservation of mucocutaneous bridges. 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. In the control 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.

Following the surgical procedure, each participant will be provided with an individual follow up card. Using this card, participants will record their pain intensity score from postoperative day 1 to day 7, both before and after analgesic administration. Pain intensity will be assessed using a visual analog scale (VAS), where 0 -indicates no pain and 10- indicates the worst possible pain. The same card will be used to record pain intensity on postoperative days 14 and 28, as well as at the time of the first and second defecation post surgery. Analgesic therapy will consist of non steroidal anti inflammatory drugs (NSAIDs), administered twice daily for one week postoperatively. On postoperative day 28, each participant will be invited for an in person examination by a proctologist to assess quality of life and Wexner Incontinence Score. Six months after surgery, participants will be invited for a follow up in person examination by a proctologist to evaluate long term treatment outcomes.All participant data, including sex, age, disease stage, and study findings, will be recorded in a centralized Excel database. Following data collection, statistical analysis will be performed.Descriptive statistics will be used to summarize baseline demographic and clinical characteristics. Continuous variables will be presented as mean ± standard deviation or median with interquartile range, depending on data distribution. Categorical variables will be presented as frequencies and percentages.• To evaluate pain intensity on days 1-7, 14 and 28 after surgery, pain after first and second defecation, the Student's t-test will be selected to analyze independent samples, and statistical significance will set at p <0.05. Otherwise, the non parametric Mann Whitney U test will be applied. • To evaluate early and long-term complications the Pearson's Chi squared test will be used.• The strength of statistical association between groups and occurrence of postoperative will be evaluated using both relative risk (RR) and odds ratio (OR) metrics. Point estimates and 95% confidence intervals will be reported for each measure. • To evaluate a quality of life questionnaire SF-36 and Wexner Incontinence Score, the Pearson's Chi squared test will be used. Statistical significance will set at p <0.05A. Expected study outcomes:

• Reduction of pain severity from postoperative day 1 to day 7 before and after taking analgesics • Reduction of pain severity on 14 and 28 days after surgery
• Reduction of pain severity on first and second defecation after surgery
• No early complications including intraoperative and postoperative bleeding, burning sensation and itching were observed
• No complications such as anal canal stenosis, perianal scar deformation, and disease recurrence were observed after 6 months follow-up
• Improvement in quality of life among patients following open hemorrhoidectomy using APC

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Moscow
    • Moscow, Moscow, Russia, 101000
      • University Clinical Hospital №4, Sechenov University, Moscow, Russia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged ≥18 years with symptomatic grade III -IV hemorrhoids refractory to conservative treatment will eligible for inclusion.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: argon plasma coagulation- APC-arm; 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; 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.
Active Comparator: open hemorrhoidectomy using monopolar coagulation; In MC arm will be 50 participants	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity on day 14	Postoperative pain intensity will be assessed using visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).	Assessment on the postoperative day 14
Postoperative pain intensity after the first defecation	Postoperative pain intensity will be assessed using visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).	At the day of the first defecation during first week after surgery
Intraoperative bleeding	Occurrence of clinically relevant intraoperative bleeding, as assessed by the operating surgeon and documented in the operative record.	During surgery
Postoperative bleeding	Occurrence of postoperative bleeding requiring medical assessment, additional treatment, or hemostatic intervention.	From surgery through postoperative day 28
Postoperative pain intensity on day 28 after surgery	Postoperative pain intensity will be assessed using visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).	Assessment on the postoperative day 28
Postoperative pain intensity before taking analgesics	Postoperative pain intensity will be assessed using the visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).	Assessment on the postoperative day 1
Postoperative pain intensity before taking analgesics	Postoperative pain intensity will be assessed using the visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).	Assessment on the postoperative day 2
Postoperative pain intensity before taking analgesics	Postoperative pain intensity will be assessed using the visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).	Assessment on the postoperative day 3
Postoperative pain intensity before taking analgesics	Postoperative pain intensity will be assessed using the visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).	Assessment on the postoperative day 5
Postoperative pain intensity before taking analgesics	Postoperative pain intensity will be assessed using the visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).	Assessment on the postoperative day 6
Postoperative pain intensity before taking analgesics	Postoperative pain intensity will be assessed using the visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).	Assessment on the postoperative day 7
Postoperative pain intensity after the second defecation	Postoperative pain intensity will be assessed using visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain)	At the day of the second defecation during first week after surgery
Rate of Participants with postoperative burning sensation and itching	Presence of patient-reported burning sensation and itching in the anorectal area.	From surgery through postoperative day 28
Long-term outcomes: rate of Participants with anal canal stenosis, perianal scar deformation, disease recurrence	Presence of anal canal stenosis, perianal scar deformation, disease recurrence on clinical examination by a proctologist	From enrollment up to 6 months after surgery

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Sergey K Efetov, MD, PhD, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): March 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 5, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hemorrhoids; Postoperative pain; Hemorrhoidectomy; Proctology; Argon plasma coagulation; Grade III hemorrhoids; Grade IV hemorrhoids
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Hemorrhoids
• Other Study ID Numbers: SKE00101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No