Hemorrhoids: Options of Traditional Hemorrhoidectomy

Hemorrhoids Clinical Trial

Official title:

Evaluation of Hemorrhoidectomy Techniques: Scalpel and Electrosurgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06132152
• Other study ID #: 59954654
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2023
• Source: Center of Endourology "Endocenter"
• Contact: Tatiana Garmanova, PhD
• Phone: +79773429249
• Email: tatianagarmanova[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

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
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.

Locations

Country	Name	City	State
Russian Federation	Surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Center of Endourology "Endocenter"

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	during 10 days after surgery
Secondary	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)	3 days after surgery
Secondary	Other medications use	The frequency of other analgesics taken	10 days after surgery
Secondary	Readmission rate	The number of cases of repeated appeals for relapse of the disease or hospitalizations	30 days after surgery
Secondary	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.	7 and 30 days
Secondary	Complication rate	Cases of bleeding, urinary retention, infectious complications after surgery	within 30 days after surgery
Secondary	Residual symptoms	The presence of residual symptoms after surgery	30 days after surgery