Hemorrhoids, Open Hemorrhoidectomy
Conditions
Keywords
symptomatic hemorrhoids, open hemorrhoidectomy, postoperative pain, electrosurgery
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.
Interventions
PROCEDUREOpen 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.
PROCEDUREOpen 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.
Sponsors
Center of Endourology Endocenter
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Before the operation, all patients are scheduled to perform an open hemorrhoidectomy, which includes radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Patients are not informed about which instrument will be used. 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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Other medications use | 10 days after surgery | The frequency of other analgesics taken |
| Readmission rate | 30 days after surgery | The number of cases of repeated appeals for relapse of the disease or hospitalizations |
| 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) |
| Complication rate | within 30 days after surgery | Cases of bleeding, urinary retention, infectious complications after surgery |
| Residual symptoms | 30 days after surgery | The presence of residual symptoms 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. |
Countries
Russia
Contacts
Primary ContactTatiana Garmanova, PhD
Backup ContactEkaterina Kazachenko, MD
Outcome results
None listed