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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
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 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.
Surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University
Moscow, Russia
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)
Time frame: during 10 days after surgery
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)
Time frame: 3 days after surgery
Other medications use
The frequency of other analgesics taken
Time frame: 10 days after surgery
Readmission rate
The number of cases of repeated appeals for relapse of the disease or hospitalizations
Time frame: 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.
Time frame: 7 and 30 days
Complication rate
Cases of bleeding, urinary retention, infectious complications after surgery
Time frame: within 30 days after surgery
Residual symptoms
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The presence of residual symptoms after surgery
Time frame: 30 days after surgery