An interventional study of open hemorrhoidectomy using argon plasma coagulation and open hemorrhoidectomy using momopolar coagulation in Hemorrhoidal Disease, Hemorrhoid Pain and Hemorrhoidectomy, sponsored by I.M. Sechenov First Moscow State Medical University. Active, not recruiting at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment
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.
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:
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:
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's enrollment of 100 is close to the median of 97 across 169 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
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
In MC arm will be 50 participants
Procedure: open hemorrhoidectomy using momopolar 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.
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
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;
Time frame: Assessment on the fourth postoperative day
Postoperative pain intensity on day 14
Postoperative pain intensity will be assessed using visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).
Time frame: 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).
Time frame: 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.
Time frame: During surgery
Postoperative bleeding
Occurrence of postoperative bleeding requiring medical assessment, additional treatment, or hemostatic intervention.
Time frame: From surgery through postoperative day 28
Rate of Participants with postoperative burning sensation and itching
Presence of patient-reported burning sensation and itching in the anorectal area.
Time frame: 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).
Time frame: Assessment on the 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
Time frame: From enrollment up to 6 months after surgery
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: At the day of the second defecation during first week after surgery
Plan to share: Undecided
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I.M. Sechenov First Moscow State Medical University