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

NCT06764849 | Withdrawn

• 1 other identifier: IB5478/24
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hemorrhoidectomy; Hemorrhoids Third Degree; Hemorrhoidal Disease; Postoperative Pain

Keywords

hemorrhoidal disease; minimally invasive open excisional hemorrhoidectomy; open excisional hemorrhoidectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Efficacy of the treatment using the Hemorrhoidal Disease Symptom Score

  1 year

• Efficacy of treatment using the Short Health Scale adapted for hemorrhoidal disease

  1 year

Study Arms (2)

OPEN EXCISIONAL HEMORRHOIDECTOMY

ACTIVE COMPARATOR

Patients will undergo conventional open excisional hemorrhoidectomy

Procedure: CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY

MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY

EXPERIMENTAL

Patients will undergo open excisional hemorrhoidectomy using a minimally invasive technique

Procedure: MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY

Interventions

CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY PROCEDURE

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

OPEN EXCISIONAL HEMORRHOIDECTOMY

MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY PROCEDURE

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

MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Son Llatzer: lead

Related Publications (1)

• 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.

  PMID: 30451751 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GENERAL SURGERY SPECIALIST

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 8, 2025
• Study Start: February 1, 2026
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share