Implementation of Minimally Invasive Surgery for Grade III Hemorrhoids

Hospital Son Llatzer

Status: Completed

Conditions: Minimal Invasive Surgery; Hemorrhoidectomy

Treatments: Procedure: Minimal invasive hemorrhoidectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06851312

HEM IDEAL1

Details and patient eligibility

About

Hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. Their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. In advanced cases (Goligher Grade III-IV), surgery is the only effective treatment. Open excisional hemorrhoidectomy (OEH), based on the Milligan-Morgan technique, is the standard procedure. Although effective in the long term, it causes severe postoperative pain.

Minimally invasive surgery (MIS) employs enhanced visualization devices to improve surgical precision and reduce tissue damage. While widely used in specialties with small surgical fields, it has not yet been explored in anal surgery. Its advantages include reduced tissue injury and improved healing, although it presents a learning curve and an initially longer surgical time.

The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. In Stage 1, the first application in humans is documented, analyzing outcomes and feasibility.

Since no previous studies on the application of MIS in OEH have been found, the investigators propose a study within Stage 1 of the IDEAL model to assess the feasibility of this technique. The investigators believe its incorporation into open excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

• Age over 18 years
• Grade III hemorrhoids
• BMI below 30
• Indication for OEH surgery
• Signed written informed consent

EXCLUSION CRITERIA

• Acute hemorrhoidal disease (thrombosis)
• Previous hemorrhoid surgery
• Coexistence of anal fissure
• Coexistence of perianal fistula
• Coexistence of rectal or anal prolapse
• Active inflammatory bowel disease
• Active anal or colorectal cancer
• Language barrier or difficulty in oral and/or written comprehension

Trial design

5 participants in 1 patient group

Grade III Hemorrhoids

Description:

Patients with symptomatic grade III hemorrhoids who consent to surgical intervention

Treatment:

Procedure: Minimal invasive hemorrhoidectomy