Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy (ARGO)

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