HemorrhoidsNCT06132152
Hemorrhoids: Options of Traditional Hemorrhoidectomy
A study testing Open hemorrhoidectomy with 'cold' scalpel and Open hemorrhoidectomy with electrosurgical scalpel in people with Hemorrhoids and Open Hemorrhoidectomy, run by Center of Endourology "Endocenter" at 1 site in Russia.
Trial summary
The goal of this prospective clinical trial is to compare the outcomes of several technical options of open hemorrhoidectomy in patients with symptomatic hemorrhoids. Randomly allocated participants will undergo surgical treatment for hemorrhoids with one technical option of open hemorrhoidecomy: with 'cold' scalpel… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Open Hemorrhoidectomy
- What is being tested?
- Open hemorrhoidectomy with 'cold' scalpel and Open hemorrhoidectomy with electrosurgical scalpel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients over 18 years old
- Diagnosed symptomatic hemorrhoidal disease
- Planned surgery - open hemorrhoidectomy
- Absence of other anarectal diseases
- I, II class of anesthetic risk according to ASA classification
- Voluntary signing by the participant of an informed consent for surgical treatment and participation in a clinical trial.
Who cannot join
- Chronic or prolonged use of medications, including narcotic drugs, with analgesic effect for other diseases.
- Patients who have contraindications or technical impossibility of performing subarachnoid anesthesia or the full standard volume of surgery for the corresponding disease.
- Patients who refused to participate at any time before the end of the study, as well as patients who did not pass the final postoperative monitoring (1 month after the intervention).
- Pregnant women
- Complicated course of the postoperative period due to exacerbation of concomitant diseases
Trial locations and contacts
1 site in 1 country.
Russia1 site
Surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University
Moscow, 119991
Tatiana Garmanova, PhD, +79773429249, tatianagarmanova@gmail.com
Ekaterina Kazachenko, MD, +79269721922, ekaterina.k.97@mail.ru
About this study
Official title: Evaluation of Hemorrhoidectomy Techniques: Scalpel and Electrosurgery
The goal of this prospective clinical trial is to compare the outcomes of several technical options of open hemorrhoidectomy in patients with symptomatic hemorrhoids. Randomly allocated participants will undergo surgical treatment for hemorrhoids with one technical option of open hemorrhoidecomy: with 'cold' scalpel or electrosurgical instruments. All information to evaluate outcomes between the groups will be collected before surgery and 1 week and 30 days after surgery.
Read the detailed description
This is a single-center prospective randomized controlled study will be conducted on the basis of the surgical department. Patients with symptomatic hemorrhoids and who will be intended for surgical treatment (open hemorrhoidectomy) will be randomly allocated to one of the group. Prior to surgery the demographic and clinical data will be collected. Open hemorrhoidectomy under spinal anesthesia will be performed with one of the technical options according to the patient's group:
- hemorrhoidectomy with 'cold' scalpel for cutting the perianal skin and anal mucose
- hemorrhoidectomy with electrosurgical scalpel for cutting the perianal skin and anal mucose.
Intraoperative and postoperative data will be collected during first week after surgery and 30 days after surgery. Then the primary and secondary outcomes are evaluated between the groups.
- Conditions
- Hemorrhoids, Open Hemorrhoidectomy
- Being tested
- Open hemorrhoidectomy with 'cold' scalpel, Open hemorrhoidectomy with electrosurgical scalpel
- Keywords
- symptomatic hemorrhoids, open hemorrhoidectomy, postoperative pain, electrosurgery
- Medical subject headings
- Hemorrhoids, Pain, Postoperative, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open hemorrhoidectomy with 'cold' scalpelProcedure or surgery
Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. 'Cold' scalpel will be used for cutting the perianal skin and anal mucose. To stop and prevent bleeding the monopolar coagulation may be used but on low energy level and with no touching the skin and mucose.
Open hemorrhoidectomy with electrosurgical scalpelProcedure or surgery
Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Electrosurgical scalpel will be used during all steps including cutting the perianal skin and anal mucose and to stop and prevent bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Open hemorrhoidectomy with 'cold' scalpel | Active comparator | Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. 'Cold' scalpel will be used for cutting the perianal skin and anal mucose. To stop and prevent bleeding the monopolar coagulation may be used but on low energy level and with no touching the skin and mucose. Receives: Procedure: Open hemorrhoidectomy with 'cold' scalpel |
| Open hemorrhoidectomy with electrosurgical scalpel | Active comparator | Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Electrosurgical scalpel will be used during all steps including cutting the perianal skin and anal mucose and to stop and prevent bleeding. Receives: Procedure: Open hemorrhoidectomy with electrosurgical scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest and during defecation
The pain was assessed using a visual analogue scale (VAS uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end)
Measured: during 10 days after surgery
Secondary outcomes (6)
Rate of prescribing opioid analgesics
the rate of prescribing opioid analgesics to prevent the pain from rising above VAS 5 after surgery (VAS uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end)
Measured: 3 days after surgery
Other medications use
The frequency of other analgesics taken
Measured: 10 days after surgery
Readmission rate
The number of cases of repeated appeals for relapse of the disease or hospitalizations
Measured: 30 days after surgery
The life quality rate
The overall quality of life was assessed using the EQ-5D patient questionnaire. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Measured: 7 and 30 days
Complication rate
Cases of bleeding, urinary retention, infectious complications after surgery
Measured: within 30 days after surgery
Residual symptoms
The presence of residual symptoms after surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In case of meeting inclusion criteria of patient the selection of the group will be determined by randomization, so both groups will be recruited simultaneously
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center of Endourology "Endocenter"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132152
- Sponsor's protocol ID
- 59954654
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemorrhoidectomy Techniques: Scalpel and Electrosurgery
- ClinicalTrials.gov ID
- NCT06132152
- Acronym / sponsor ID
- 59954654
- Conditions
- Hemorrhoids, Open Hemorrhoidectomy
- Keywords
- symptomatic hemorrhoids, open hemorrhoidectomy, postoperative pain, electrosurgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Center of Endourology "Endocenter"University, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 15 Nov 2023 (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.
The goal of this prospective clinical trial is to compare the outcomes of several technical options of open hemorrhoidectomy in patients with symptomatic hemorrhoids. Randomly allocated participants will undergo surgical treatment for hemorrhoids with one technical option of open hemorrhoidecomy: with 'cold' scalpel or electrosurgical instruments. All information to evaluate outcomes between the groups will be collected before surgery and 1 week and 30 days after surgery.
Detailed description
This is a single-center prospective randomized controlled study will be conducted on the basis of the surgical department. Patients with symptomatic hemorrhoids and who will be intended for surgical treatment (open hemorrhoidectomy) will be randomly allocated to one of the group. Prior to surgery the demographic and clinical data will be collected. Open hemorrhoidectomy under spinal anesthesia will be performed with one of the technical options according to the patient's group:
- hemorrhoidectomy with 'cold' scalpel for cutting the perianal skin and anal mucose
- hemorrhoidectomy with electrosurgical scalpel for cutting the perianal skin and anal mucose.
Intraoperative and postoperative data will be collected during first week after surgery and 30 days after surgery. Then the primary and secondary outcomes are evaluated between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In case of meeting inclusion criteria of patient the selection of the group will be determined by randomization, so both groups will be recruited simultaneously
| Arm | Type | Receives |
|---|---|---|
| Open hemorrhoidectomy with 'cold' scalpel | Active comparator | Procedure: Open hemorrhoidectomy with 'cold' scalpelOpen hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. 'Cold' scalpel will be used for cutting the perianal skin and anal mucose. To stop and prevent bleeding the monopolar coagulation may be used but on low energy level and with no touching the skin and mucose. |
| Open hemorrhoidectomy with electrosurgical scalpel | Active comparator | Procedure: Open hemorrhoidectomy with electrosurgical scalpelOpen hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Electrosurgical scalpel will be used during all steps including cutting the perianal skin and anal mucose and to stop and prevent bleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years old
- Diagnosed symptomatic hemorrhoidal disease
- Planned surgery - open hemorrhoidectomy
- Absence of other anarectal diseases
- I, II class of anesthetic risk according to ASA classification
Key exclusion criteria (5 listed)
- Chronic or prolonged use of medications, including narcotic drugs, with analgesic effect for other diseases.
- Patients who have contraindications or technical impossibility of performing subarachnoid anesthesia or the full standard volume of surgery for the corresponding disease.
- Patients who refused to participate at any time before the end of the study, as well as patients who did not pass the final postoperative monitoring (1 month after the intervention).
- Pregnant women
- Complicated course of the postoperative period due to exacerbation of concomitant diseases
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 |
|---|---|---|
| Open hemorrhoidectomy with 'cold' scalpelOpen hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. 'Cold' scalpel will be used for cutting the perianal skin and anal mucose. To stop and prevent bleeding the monopolar coagulation may be used but on low energy level and with no touching the skin and mucose. | Procedure or surgery | Open hemorrhoidectomy with 'cold' scalpel |
| Open hemorrhoidectomy with electrosurgical scalpelOpen hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Electrosurgical scalpel will be used during all steps including cutting the perianal skin and anal mucose and to stop and prevent bleeding. | Procedure or surgery | Open hemorrhoidectomy with electrosurgical scalpel |
Primary outcome
Pain at rest and during defecation
Time frame: during 10 days after surgery
The pain was assessed using a visual analogue scale (VAS uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end)
6 secondary outcomes
Rate of prescribing opioid analgesics
Time frame: 3 days after surgery
Other medications use
Time frame: 10 days after surgery
Readmission rate
Time frame: 30 days after surgery
The life quality rate
Time frame: 7 and 30 days
Complication rate
Time frame: within 30 days after surgery
Residual symptoms
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open hemorrhoidectomy with 'cold' scalpel and Open hemorrhoidectomy with electrosurgical scalpel in people with Hemorrhoids and Open Hemorrhoidectomy, run by Center of Endourology "Endocenter" 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Nov 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Garmanova, PhD (+79773429249, tatianagarmanova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at rest and during defecation (time frame: during 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2023.