Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2023-12-01
2024-11-01
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
All collected information will be stored in electronic databases, where patient names and group numbers are anonymized and encrypted. Thus, during the statistical calculation, a person will not know about the name of the group.
Study Groups
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Open hemorrhoidectomy with 'cold' scalpel
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 'cold' scalpel
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 scalpel
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.
Open hemorrhoidectomy with electrosurgical scalpel
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.
Interventions
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Open hemorrhoidectomy with 'cold' scalpel
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 scalpel
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Center of Endourology "Endocenter"
OTHER
Responsible Party
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Locations
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Surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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59954654
Identifier Type: -
Identifier Source: org_study_id
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