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

Hospital Son Llatzer

Status: Withdrawn

Conditions: Postoperative Pain; Hemorrhoids Third Degree; Hemorrhoidectomy; Hemorrhoidal Disease

Treatments: Procedure: MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY; Procedure: CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY

Study type: Interventional

Funder types: Other

Identifiers

NCT06764849

IB5478/24

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age older than 18 years.
• Hemorrhoids grade III.
• Surgical indication for hemorrhoidal disease.

Exclusion criteria

• Acute hemorrhoidal disease.
• Previous hemorrhoidal surgery.
• Concomitant anal fissure.
• Concomitant anal fistulae.
• Concomitant rectal prolapse.
• Concomitant inflamatory bowel disease or anal cancer.
• Language impairment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

OPEN EXCISIONAL HEMORRHOIDECTOMY

Active Comparator group

Description:

Patients will undergo conventional open excisional hemorrhoidectomy

Treatment:

Procedure: CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY

MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY

Experimental group

Description:

Patients will undergo open excisional hemorrhoidectomy using a minimally invasive technique

Treatment:

Procedure: MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY