NCT06764849

Minimally Invasive Open Excisional Hemorrhoidectomy Compared to Conventional Open Excisional Hemorrhoidectomy: a Clinical Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital Son Llatzer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to demonstrate that open excisional hemorrhoidectomy (OEH), when performed using a minimally invasive approach, results in less postoperative pain and comparable outcomes to conventional OEH.

Detailed description

At our hospital, the investigators have developed a new approach to hemorrhoid surgery by modifying the traditional open excisional hemorrhoidectomy. This new method incorporates an image-amplifying device and utilizes microsurgery tools. Preliminary results have shown significant improvement in patients' immediate postoperative pain, with efficacy comparable to conventional methods one year after treatment. We propose conducting a clinical trial to confirm these initial findings. The study will include two gropus: one undergoing conventional open excisional hemorrhoidectomy (OEH) and the other receiving minimally invasive open excisional hemorrhoidectomy (miOEH). Patients will be randomly assigned to one of these two groups. The primary outcome of interest will be the level of postoperative pain assessed 10 days after surgery. The secondary outcomes will evaluate the effectiveness of the technique one year post-surgery, measured by the Hemorrhoidal Disease Symptom Score(HDSS) and the Short Health Scale in Hemorrhoidal Disease (SHSHD).

Conditions

• Hemorrhoidectomy
• Hemorrhoids Third Degree
• Hemorrhoidal Disease
• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY	Hemorrhoidectomy performed based on the conventional technique described by Milligan-Morgan
PROCEDURE	MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY	Hemorrhoidectomy performed based on the tecnique described by Milligan Morgan, using a minimally invasive approach.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2025-01-08
• Last updated: 2025-09-03