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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06764849
• Lead Sponsor: Hospital Son Llatzer

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.

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 Timeline

• Study First Submitted: 2024-12-23
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25
• Study Start: 2026-02-01
• Primary Completion: 2026-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative pain measured with the visual analogic scale	10 days	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.
Postoperative pain measured by the number of rescue painkillers needed	10 days	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..

Secondary Outcome Measures

Name	Time	Method
Efficacy of the treatment using the Hemorrhoidal Disease Symptom Score	1 year	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
Efficacy of treatment using the Short Health Scale adapted for hemorrhoidal disease	1 year	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