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

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.

Study Overview

• Status: Withdrawn
• Conditions: Postoperative Pain; Hemorrhoidal Disease; Hemorrhoidectomy; Hemorrhoids Third Degree
• Intervention / Treatment: Procedure: CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY; Procedure: MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OPEN EXCISIONAL HEMORRHOIDECTOMY; Patients will undergo conventional open excisional hemorrhoidectomy	Procedure: CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY; Hemorrhoidectomy performed based on the conventional technique described by Milligan-Morgan
Experimental: MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY; Patients will undergo open excisional hemorrhoidectomy using a minimally invasive technique	Procedure: MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY; Hemorrhoidectomy performed based on the tecnique described by Milligan Morgan, using a minimally invasive approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain measured with the visual analogic scale	Postoperative pain presented 10 days after the surgical procedure was measured using the visual analogic scale (VAS). Operationally, a VAS is a horizontal line 100 mm long anchored by word descriptors at each end; on the left-hand end, it says "no pain," and on the right-hand end of the line, it says "very severalPostoperative pain was assessed 10 days after the surgical procedure using the visual analog scale (VAS). The VAS consists of a 100 mm horizontal line, with descriptors at each end. The left end is labeled "no pain," while the right end is labeled "very severe pain." Patients indicate their perception of pain by marking a point on the line. The VAS score is then calculated by measuring the distance in millimeters from the left end of the line to pain". The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring millimetres from the left-hand end of the line to the point the patient marks.	10 days
Postoperative pain measured by the number of rescue painkillers needed	Postoperative pain presented 10 days after the surgical procedure was measured with the number of rescue painkillers needed during this period. Patients will take the following analgesic regimen: Paracetamol 1 gram every 8 hours and Dexketoprofen 12.5 milligrams every 8 hours alternately. Tramadol 50 milligrams will be used as rescue analgesia. The patient will write down the number of Tramadol tablets needed during the first 10 days on a collection sheetPostoperative pain will be assessed 10 days after the surgical procedure by recording the number of rescue painkillers used during this time. Patients will follow this analgesic regimen: they will take Paracetamol 1 gram every 8 hours and Dexketoprofen 12.5 milligrams every 8 hours, alternating between the two. Tramadol 50 milligrams will be available as rescue analgesia. Patients should note the number of Tramadol tablets taken during the first 10 days on a collection sheet..	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the treatment using the Hemorrhoidal Disease Symptom Score	We analyse the efficacy of both procedures using the difference in scores between before and 1 year after surgery on the Hemorrhoidal Disease Symptom Score (HDSS). The HDSS was assessed using the patient-reported frequency of the five symptoms, including pain, itching, bleeding, soiling, and prolapse. Patients were instructed to answer based on their experience during the previous 3 months. Each symptom was graded on a 5-point scale (0 = never, 1 = less than once a month, 2 = less than once a week, 3 = 1-6 days per week, 4 = every day or always), giving a total score ranging from 0 to 20	1 year
Efficacy of treatment using the Short Health Scale adapted for hemorrhoidal disease	We analyze the effectiveness of both procedures by comparing the scores on the Short Health Scale adapted for hemorrhoidal disease (SHD-HD) before surgery and one year post-surgery. Patients were asked to report their overall symptom burden, how hemorrhoidal disease interfered with their daily activities, and the concerns it caused them. The fourth question focused on their general well-being. This assessment used a 7-point Likert scale, resulting in a total score that ranges from 4 to 28, with higher values indicating worse health out	1 year

Collaborators and Investigators

• Sponsor: Hospital Son Llatzer

Publications and helpful links

General Publications

• Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 8, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: hemorrhoidal disease; minimally invasive open excisional hemorrhoidectomy; open excisional hemorrhoidectomy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: IB5478/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No