HemorrhoidsPhase 2BoTo-HEMNCT07399860
Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain
A Phase 2 study testing Botulinum toxin type A and Saline (0.9% NaCl) in people with Hemorrhoids and Postoperative Pain, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.
Trial summary
Hemorrhoidectomy is an effective surgical treatment for advanced hemorrhoidal disease but is often associated with significant postoperative pain, which may delay recovery. One of the main contributors to pain after hemorrhoidectomy is spasm and increased tone of the internal anal sphincter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Postoperative Pain
- What is being tested?
- Botulinum toxin type A and Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2026to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years, male and female
- Symptomatic grade III-IV hemorrhoidal disease (Goligher), refractory to conservative treatment
- Scheduled for open (Milligan-Morgan) or closed (Ferguson) hemorrhoidectomy
Who cannot join
- Known hypersensitivity to botulinum toxin A, human albumin, or local anesthetics.
- Neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome).
- Use of aminoglycosides or other agents interfering with neuromuscular transmission within 14 days.
- Coagulopathy or ongoing anticoagulant therapy not suitable for perioperative interruption.
- Active anorectal infection, fissure, abscess, or inflammatory bowel disease in the active phase.
- Previous anal sphincter surgery or baseline fecal incontinence.
Show all 9Show fewer
- Pregnancy or breastfeeding.
- ASA ≥ III or significant systemic disease compromising anesthesia or wound healing.
- Participation in another interventional clinical trial within 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Lomonosov Moscow State University Medical Research and Educational Center
Moscow, Moscow, 119991
Tatiana Garmanova, MD, PhD, + 7 977 342 92 49, tatianagarmanova@gmail.com
Aleksandr Lukianov, MD, + 7 916 772 93 03, alexmax|1225469@gmail.com
About this study
Official title: Effect of Internal Anal Sphincter Botulinum Toxin A Injection 7 Days Before Hemorrhoidectomy on Postoperative Pain: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Hemorrhoidectomy is an effective surgical treatment for advanced hemorrhoidal disease but is often associated with significant postoperative pain, which may delay recovery. One of the main contributors to pain after hemorrhoidectomy is spasm and increased tone of the internal anal sphincter.
This randomized, double-blind, placebo-controlled clinical trial evaluates whether preoperative injection of botulinum toxin type A into the internal anal sphincter, performed seven days before hemorrhoidectomy, can reduce postoperative pain compared with placebo. Adult patients with grade III-IV hemorrhoids scheduled for excisional hemorrhoidectomy will be randomized to receive either botulinum toxin A or saline injection prior to surgery.
Postoperative pain intensity, analgesic consumption, complications, functional outcomes, and patient satisfaction will be assessed during the first 30 days after surgery.
Read the detailed description
This multicenter, randomized, double-blind, placebo-controlled trial is designed to investigate the effect of preoperative botulinum toxin type A injection into the internal anal sphincter on postoperative pain following excisional hemorrhoidectomy.
Eligible adult patients with symptomatic grade III-IV hemorrhoids will be randomized in a 1:1 ratio to receive either botulinum toxin type A or placebo injection seven days prior to surgery. Botulinum toxin A will be injected into the internal anal sphincter in four quadrants using a standardized technique, while the control group will receive an identical volume of normal saline. Both patients and surgeons performing hemorrhoidectomy, as well as outcome assessors, will be blinded to treatment allocation.
All participants will subsequently undergo open or closed hemorrhoidectomy using standardized surgical and perioperative care protocols. Postoperative pain will be assessed using a visual analogue scale during the first seven postoperative days. Secondary outcomes include analgesic consumption, postoperative complications, length of hospital stay, transient fecal incontinence, time to first bowel movement, readmissions, and patient-reported satisfaction within 30 days after surgery.
The study aims to determine whether preoperative chemical sphincter relaxation with botulinum toxin A can improve postoperative recovery and reduce pain following hemorrhoidectomy.
- Conditions
- Hemorrhoids, Postoperative Pain
- Being tested
- Botulinum toxin type A, Saline (0.9% NaCl)
- Keywords
- Hemorrhoidectomy, Botulinum toxin, Postoperative pain, Anal sphincter spasm
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called botox, BTX-A
Participants receive a single preoperative injection of botulinum toxin type A into the internal anal sphincter. The injection is administered seven days prior to excisional hemorrhoidectomy. Botulinum toxin type A is injected in divided doses at predefined points of the internal anal sphincter using standard technique. The intervention is performed once and no repeat injections are planned.
Saline (0.9% NaCl)Drug
Participants receive a single preoperative injection of normal saline into the internal anal sphincter. The injection is administered seven days prior to excisional hemorrhoidectomy. Normal saline is injected in divided doses at the same predefined points and using the same technique and injection volume as in the experimental group. The intervention is performed once, with no repeat injections planned.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Botulinum Toxin A Injection | Experimental | Participants receive a preoperative injection of botulinum toxin type A into the internal anal sphincter seven days prior to excisional hemorrhoidectomy, in addition to standard surgical treatment. Receives: Drug: Botulinum toxin type A |
| Preoperative Placebo Injection | Placebo comparator | Participants receive a preoperative injection of normal saline into the internal anal sphincter seven days prior to excisional hemorrhoidectomy, in addition to standard surgical treatment. Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Within the First 7 Days After Hemorrhoidectomy
Postoperative pain intensity assessed using a 100-mm visual analogue scale (VAS). Daily pain scores are recorded and used to calculate the area under the curve (AUC) over postoperative days 1-7 for comparison between study groups.
Measured: Postoperative days 1-7
Secondary outcomes (8)
Total opioid consumption within 72 hours postoperatively
Total postoperative opioid consumption expressed in morphine equivalents (mg) measured within the first 72 hours after surgery. Opioid use is recorded and compared between the botulinum toxin type A group and the placebo group.
Measured: Within 72 hours after surgery (postoperative hours 0-72)
Length of hospital stay
Length of postoperative hospital stay measured in days, calculated from the day of surgery to the day of hospital discharge, and compared between the botulinum toxin type A group and the placebo group.
Measured: From day of surgery until hospital discharge (up to 30 days postoperatively)
Incidence of postoperative complications within 30 days
Incidence of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo classification, and compared between the botulinum toxin type A group and the placebo group.
Measured: Within 30 days after surgery
Transient fecal incontinence rates assessed by Wexner score
Transient fecal incontinence assessed using the Wexner score to evaluate severity and frequency of symptoms, and compared between the botulinum toxin type A group and the placebo group.
Measured: Postoperative days 14 and 30
Readmission or unplanned medical visits within 30 days
Hospital readmission or unplanned medical visits occurring within 30 days after surgery, compared between the botulinum toxin type A group and the placebo group.
Measured: Within 30 days postoperatively
Pain during defecation assessed by VAS
Pain intensity during defecation assessed using the Visual Analog Scale (VAS) and compared between the botulinum toxin type A group and the placebo group.
Measured: Postoperative days 1, 3, and 7
Time to first bowel movement
Time to first bowel movement measured in hours and compared between the botulinum toxin type A group and the placebo group.
Measured: From day of surgery until first bowel movement (up to hospital discharge, maximum 7 days)
Patient satisfaction score
Patient satisfaction assessed using a numeric rating scale from 0 to 10, where higher scores indicate greater satisfaction. Scores are compared between the botulinum toxin type A group and the placebo group.
Measured: Postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lomonosov Moscow State University Medical Research and Educational Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tatiana Garmanova, MD, PhD, Study director, Lomonosov Moscow State University Medical Research and Educational Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399860
- Sponsor's protocol ID
- BoTo-HEM RCT
- Acronym
- BoTo-HEM
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional and ethical restrictions and because no data-sharing plan is specified in the study protocol.
Publications
Lie H, Lukito PP, Sudirman T, Purnama AA, Sutedja R, Setiawan A, Jeo WS, Irawan A, Satriya W, Koerniawan HS, Hariyanto TI. Utility of botulinum toxin injection for post-operative pain management after conventional hemorrhoidectomy: a systematic review and meta-analysis of clinical trials. Scand J Gastroenterol. 2023 Feb;58(2):116-122. doi: 10.1080/00365521.2022.2116292. Epub 2022 Sep 1.
PubMed 36048469Patti R, Arcara M, Bonventre S, Sammartano S, Sparacello M, Vitello G, Di Vita G. Randomized clinical trial of botulinum toxin injection for pain relief in patients with thrombosed external haemorrhoids. Br J Surg. 2008 Nov;95(11):1339-43. doi: 10.1002/bjs.6236.
PubMed 18844269Jin J, Unasa H, Bahl P, Mauiliu-Wallis M, Svirskis D, Hill A. Can Targeting Sphincter Spasm Reduce Post-Haemorrhoidectomy Pain? A Systematic Review and Meta-Analysis. World J Surg. 2023 Feb;47(2):520-533. doi: 10.1007/s00268-022-06807-3. Epub 2022 Nov 10.
PubMed 36357803Quinn R, Jamsari G, Albayati S. Botulinum toxin injection for management of post-haemorrhoidectomy pain: an updated systematic review and meta-analysis of randomised clinical trials. Tech Coloproctol. 2025 Apr 7;29(1):96. doi: 10.1007/s10151-025-03137-z.
PubMed 40192825Sirikurnpiboon S, Jivapaisarnpong P. Botulinum Toxin Injection for Analgesic Effect after Hemorrhoidectomy: A Randomized Control Trial. J Anus Rectum Colon. 2020 Oct 29;4(4):186-192. doi: 10.23922/jarc.2020-027. eCollection 2020.
PubMed 33134600Yaghoobi Notash A, Sadeghian E, Heshmati A, Sorush A. Effectiveness of Local Botulinum Toxin Injection for Perianal Pain after Hemorrhoidectomy. Middle East J Dig Dis. 2022 Jul;14(3):330-334. doi: 10.34172/mejdd.2022.291. Epub 2022 Jul 30.
PubMed 36619264Patti R, Almasio PL, Muggeo VM, Buscemi S, Arcara M, Matranga S, Di Vita G. Improvement of wound healing after hemorrhoidectomy: a double-blind, randomized study of botulinum toxin injection. Dis Colon Rectum. 2005 Dec;48(12):2173-9. doi: 10.1007/s10350-005-0179-5.
PubMed 16400513Davies J, Duffy D, Boyt N, Aghahoseini A, Alexander D, Leveson S. Botulinum toxin (botox) reduces pain after hemorrhoidectomy: results of a double-blind, randomized study. Dis Colon Rectum. 2003 Aug;46(8):1097-102. doi: 10.1007/s10350-004-7286-6.
PubMed 12907905
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Internal Anal Sphincter Botulinum Toxin A Injection 7 Days Before Hemorrhoidectomy on Postoperative Pain: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07399860
- Acronym / sponsor ID
- BoTo-HEM / BoTo-HEM RCT
- Conditions
- Hemorrhoids, Postoperative Pain
- Keywords
- Hemorrhoidectomy, Botulinum toxin, Postoperative pain, Anal sphincter spasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Lomonosov Moscow State University Medical Research and Educational CenterUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemorrhoidectomy is an effective surgical treatment for advanced hemorrhoidal disease but is often associated with significant postoperative pain, which may delay recovery. One of the main contributors to pain after hemorrhoidectomy is spasm and increased tone of the internal anal sphincter.
This randomized, double-blind, placebo-controlled clinical trial evaluates whether preoperative injection of botulinum toxin type A into the internal anal sphincter, performed seven days before hemorrhoidectomy, can reduce postoperative pain compared with placebo. Adult patients with grade III-IV hemorrhoids scheduled for excisional hemorrhoidectomy will be randomized to receive either botulinum toxin A or saline injection prior to surgery.
Postoperative pain intensity, analgesic consumption, complications, functional outcomes, and patient satisfaction will be assessed during the first 30 days after surgery.
Detailed description
This multicenter, randomized, double-blind, placebo-controlled trial is designed to investigate the effect of preoperative botulinum toxin type A injection into the internal anal sphincter on postoperative pain following excisional hemorrhoidectomy.
Eligible adult patients with symptomatic grade III-IV hemorrhoids will be randomized in a 1:1 ratio to receive either botulinum toxin type A or placebo injection seven days prior to surgery. Botulinum toxin A will be injected into the internal anal sphincter in four quadrants using a standardized technique, while the control group will receive an identical volume of normal saline. Both patients and surgeons performing hemorrhoidectomy, as well as outcome assessors, will be blinded to treatment allocation.
All participants will subsequently undergo open or closed hemorrhoidectomy using standardized surgical and perioperative care protocols. Postoperative pain will be assessed using a visual analogue scale during the first seven postoperative days. Secondary outcomes include analgesic consumption, postoperative complications, length of hospital stay, transient fecal incontinence, time to first bowel movement, readmissions, and patient-reported satisfaction within 30 days after surgery.
The study aims to determine whether preoperative chemical sphincter relaxation with botulinum toxin A can improve postoperative recovery and reduce pain following hemorrhoidectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Botulinum Toxin A Injection | Experimental | Drug: Botulinum toxin type AParticipants receive a preoperative injection of botulinum toxin type A into the internal anal sphincter seven days prior to excisional hemorrhoidectomy, in addition to standard surgical treatment. |
| Preoperative Placebo Injection | Placebo comparator | Drug: Saline (0.9% NaCl)Participants receive a preoperative injection of normal saline into the internal anal sphincter seven days prior to excisional hemorrhoidectomy, in addition to standard surgical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years, male and female
- Symptomatic grade III-IV hemorrhoidal disease (Goligher), refractory to conservative treatment
- Scheduled for open (Milligan-Morgan) or closed (Ferguson) hemorrhoidectomy
Key exclusion criteria (9 listed)
- Known hypersensitivity to botulinum toxin A, human albumin, or local anesthetics.
- Neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome).
- Use of aminoglycosides or other agents interfering with neuromuscular transmission within 14 days.
- Coagulopathy or ongoing anticoagulant therapy not suitable for perioperative interruption.
- Active anorectal infection, fissure, abscess, or inflammatory bowel disease in the active phase.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: botox, BTX-AParticipants receive a single preoperative injection of botulinum toxin type A into the internal anal sphincter. The injection is administered seven days prior to excisional hemorrhoidectomy. Botulinum toxin type A is injected in divided doses at predefined points of the internal anal sphincter using standard technique. The intervention is performed once and no repeat injections are planned. | Drug | Preoperative Botulinum Toxin A Injection |
| Saline (0.9% NaCl)Participants receive a single preoperative injection of normal saline into the internal anal sphincter. The injection is administered seven days prior to excisional hemorrhoidectomy. Normal saline is injected in divided doses at the same predefined points and using the same technique and injection volume as in the experimental group. The intervention is performed once, with no repeat injections planned. | Drug | Preoperative Placebo Injection |
Primary outcome
Postoperative Pain Intensity Within the First 7 Days After Hemorrhoidectomy
Time frame: Postoperative days 1-7
Postoperative pain intensity assessed using a 100-mm visual analogue scale (VAS). Daily pain scores are recorded and used to calculate the area under the curve (AUC) over postoperative days 1-7 for comparison between study groups.
8 secondary outcomes
Total opioid consumption within 72 hours postoperatively
Time frame: Within 72 hours after surgery (postoperative hours 0-72)
Length of hospital stay
Time frame: From day of surgery until hospital discharge (up to 30 days postoperatively)
Incidence of postoperative complications within 30 days
Time frame: Within 30 days after surgery
Transient fecal incontinence rates assessed by Wexner score
Time frame: Postoperative days 14 and 30
Readmission or unplanned medical visits within 30 days
Time frame: Within 30 days postoperatively
Pain during defecation assessed by VAS
Time frame: Postoperative days 1, 3, and 7
Time to first bowel movement
Time frame: From day of surgery until first bowel movement (up to hospital discharge, maximum 7 days)
Patient satisfaction score
Time frame: Postoperative day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Results publication: PubMed 36048469Lie H, Lukito PP, Sudirman T, Purnama AA, Sutedja R, Setiawan A, Jeo WS, Irawan A, Satriya W, Koerniawan HS, Hariyanto TI. Utility of botulinum toxin injection for post-operative pain management after conventional hemorrhoidectomy: a systematic review and meta-analysis of clinical trials. Scand J Gastroenterol. 2023 Feb;58(2):116-122. doi: 10.1080/00365521.2022.2116292. Epub 2022 Sep 1.
- Results publication: PubMed 18844269Patti R, Arcara M, Bonventre S, Sammartano S, Sparacello M, Vitello G, Di Vita G. Randomized clinical trial of botulinum toxin injection for pain relief in patients with thrombosed external haemorrhoids. Br J Surg. 2008 Nov;95(11):1339-43. doi: 10.1002/bjs.6236.
- Results publication: PubMed 36357803Jin J, Unasa H, Bahl P, Mauiliu-Wallis M, Svirskis D, Hill A. Can Targeting Sphincter Spasm Reduce Post-Haemorrhoidectomy Pain? A Systematic Review and Meta-Analysis. World J Surg. 2023 Feb;47(2):520-533. doi: 10.1007/s00268-022-06807-3. Epub 2022 Nov 10.
- Results publication: PubMed 40192825Quinn R, Jamsari G, Albayati S. Botulinum toxin injection for management of post-haemorrhoidectomy pain: an updated systematic review and meta-analysis of randomised clinical trials. Tech Coloproctol. 2025 Apr 7;29(1):96. doi: 10.1007/s10151-025-03137-z.
- Results publication: PubMed 33134600Sirikurnpiboon S, Jivapaisarnpong P. Botulinum Toxin Injection for Analgesic Effect after Hemorrhoidectomy: A Randomized Control Trial. J Anus Rectum Colon. 2020 Oct 29;4(4):186-192. doi: 10.23922/jarc.2020-027. eCollection 2020.
- Results publication: PubMed 36619264Yaghoobi Notash A, Sadeghian E, Heshmati A, Sorush A. Effectiveness of Local Botulinum Toxin Injection for Perianal Pain after Hemorrhoidectomy. Middle East J Dig Dis. 2022 Jul;14(3):330-334. doi: 10.34172/mejdd.2022.291. Epub 2022 Jul 30.
- Results publication: PubMed 16400513Patti R, Almasio PL, Muggeo VM, Buscemi S, Arcara M, Matranga S, Di Vita G. Improvement of wound healing after hemorrhoidectomy: a double-blind, randomized study of botulinum toxin injection. Dis Colon Rectum. 2005 Dec;48(12):2173-9. doi: 10.1007/s10350-005-0179-5.
- Results publication: PubMed 12907905Davies J, Duffy D, Boyt N, Aghahoseini A, Alexander D, Leveson S. Botulinum toxin (botox) reduces pain after hemorrhoidectomy: results of a double-blind, randomized study. Dis Colon Rectum. 2003 Aug;46(8):1097-102. doi: 10.1007/s10350-004-7286-6.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional and ethical restrictions and because no data-sharing plan is specified in the study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tatiana Garmanova, MD, PhD study director
Lomonosov Moscow State University Medical Research and Educational Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin type A and Saline (0.9% NaCl) in people with Hemorrhoids and Postoperative Pain, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Garmanova, MD, PhD (+ 7 977 342 92 49, tatianagarmanova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Within the First 7 Days After Hemorrhoidectomy (time frame: Postoperative days 1-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07399860, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.