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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-02-01

Brief Summary

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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.

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Detailed Description

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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

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Hemorrhoidectomy Hemorrhoids Third Degree Hemorrhoidal Disease Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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OPEN EXCISIONAL HEMORRHOIDECTOMY

Patients will undergo conventional open excisional hemorrhoidectomy

Group Type ACTIVE_COMPARATOR

CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY

Intervention Type PROCEDURE

Hemorrhoidectomy performed based on the conventional technique described by Milligan-Morgan

MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY

Patients will undergo open excisional hemorrhoidectomy using a minimally invasive technique

Group Type EXPERIMENTAL

MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY

Intervention Type PROCEDURE

Hemorrhoidectomy performed based on the tecnique described by Milligan Morgan, using a minimally invasive approach.

Interventions

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CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY

Hemorrhoidectomy performed based on the conventional technique described by Milligan-Morgan

Intervention Type PROCEDURE

MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY

Hemorrhoidectomy performed based on the tecnique described by Milligan Morgan, using a minimally invasive approach.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No