Hemorrhoids: Options of Traditional Hemorrhoidectomy
- Conditions
- HemorrhoidsOpen Hemorrhoidectomy
- Interventions
- Procedure: Open hemorrhoidectomy with 'cold' scalpelProcedure: Open hemorrhoidectomy with electrosurgical scalpel
- Registration Number
- NCT06132152
- Lead Sponsor
- Center of Endourology "Endocenter"
- Brief 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open hemorrhoidectomy with 'cold' scalpel 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 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.
- Primary Outcome Measures
Name Time Method Pain at rest and during defecation 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)
- Secondary Outcome Measures
Name Time Method Readmission rate 30 days after surgery The number of cases of repeated appeals for relapse of the disease or hospitalizations
Complication rate within 30 days after surgery Cases of bleeding, urinary retention, infectious complications after surgery
The life quality rate 7 and 30 days 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.
Rate of prescribing opioid analgesics 3 days after surgery 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)
Other medications use 10 days after surgery The frequency of other analgesics taken
Residual symptoms 30 days after surgery The presence of residual symptoms after surgery
Trial Locations
- Locations (1)
Surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University
🇷🇺Moscow, Russian Federation