Clinical trial NCT06132152: Hemorrhoids: Options of Traditional Hemorrhoidectomy
Official title: Evaluation of Hemorrhoidectomy Techniques: Scalpel and Electrosurgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemorrhoids
Open Hemorrhoidectomy
Keywords: symptomatic hemorrhoids
open hemorrhoidectomy
postoperative pain
electrosurgery
Lead sponsor: Center of Endourology "Endocenter"
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain at rest and during defecation
timeFrame: during 10 days after surgery
Secondary outcomes:
measure: Rate of prescribing opioid analgesics
timeFrame: 3 days after surgery
measure: Other medications use
timeFrame: 10 days after surgery
measure: Readmission rate
timeFrame: 30 days after surgery
measure: The life quality rate
timeFrame: 7 and 30 days
measure: Complication rate
timeFrame: within 30 days after surgery
measure: Residual symptoms
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University
Study officials:
References: