Evaluation of Hemorrhoidectomy Techniques: Scalpel and Electrosurgery
| Registry | NCT06132152 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 70 (Estimated) |
| Sponsor | Center of Endourology "Endocenter" (Other) |
| Conditions | Hemorrhoids, Open Hemorrhoidectomy |
| Interventions | Open hemorrhoidectomy with 'cold' scalpel, Open hemorrhoidectomy with electrosurgical scalpel (Procedure) |
| Dates | start 2023-12-01 (estimated), primary completion 2024-05-01 (estimated), completion 2024-11-01 (estimated), first posted 2023-11-15, last updated 2023-11-15 |
| Locations | 1 site in Russia |
Related Papers Related Patents Related Grants Related Experts
All trials for Hemorrhoids All trials for Open Hemorrhoidectomy All trials of Open hemorrhoidectomy with 'cold' scalpel All trials of Open hemorrhoidectomy with electrosurgical scalpel
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Open hemorrhoidectomy with 'cold' scalpel | Active comparator | Procedure: 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 | Active comparator | Procedure: 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University | Moscow | Russia |