Hemorrhoids: Options of Traditional Hemorrhoidectomy

Evaluation of Hemorrhoidectomy Techniques: Scalpel and Electrosurgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhoids; Open Hemorrhoidectomy
• Intervention / Treatment: Procedure: Open hemorrhoidectomy with 'cold' scalpel; Procedure: Open hemorrhoidectomy with electrosurgical scalpel

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tatiana Garmanova, PhD; Phone Number: +79773429249; Email: tatianagarmanova@gmail.com
• Study Contact Backup: Name: Ekaterina Kazachenko, MD; Phone Number: +79269721922; Email: ekaterina.k.97@mail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University
    • Contact: Tatiana Garmanova, PhD; Phone Number: +79773429249; Email: tatianagarmanova@gmail.com
    • Contact: Ekaterina Kazachenko, MD; Phone Number: +79269721922; Email: ekaterina.k.97@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Center of Endourology "Endocenter"

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: postoperative pain; electrosurgery; symptomatic hemorrhoids; open hemorrhoidectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 59954654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No