NCT06132152

Hemorrhoids: Options of Traditional Hemorrhoidectomy

Evaluation of Hemorrhoidectomy Techniques: Scalpel and Electrosurgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Center of Endourology "Endocenter" · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoids
• Open Hemorrhoidectomy

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-05-01
• Completion: 2024-11-01
• First posted: 2023-11-15
• Last updated: 2023-11-15

Locations

1 site across 1 country: Russia