HemorrhoidectomyNCT06764849
Minimally Invasive Open Excisional Hemorrhoidectomy Compared to Conventional Open Excisional Hemorrhoidectomy: a Clinical Trial
A study testing CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY and MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY in people with Hemorrhoidectomy and Hemorrhoids Third Degree, run by Hospital Son Llatzer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoidectomy, Hemorrhoids Third Degree, Hemorrhoidal Disease
- What is being tested?
- CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY and MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years.
- Hemorrhoids grade III.
- Surgical indication for hemorrhoidal disease.
Who cannot join
- Acute hemorrhoidal disease.
- Previous hemorrhoidal surgery.
- Concomitant anal fissure.
- Concomitant anal fistulae.
- Concomitant rectal prolapse.
- Concomitant inflamatory bowel disease or anal cancer.
- Language impairment.
About this study
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.
Read the 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).
- Being tested
- CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY, MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY
- Keywords
- hemorrhoidal disease, minimally invasive open excisional hemorrhoidectomy, open excisional hemorrhoidectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMYProcedure or surgery
Hemorrhoidectomy performed based on the conventional technique described by Milligan-Morgan
MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMYProcedure or surgery
Hemorrhoidectomy performed based on the tecnique described by Milligan Morgan, using a minimally invasive approach.
| Study group | Role | What they receive |
|---|---|---|
| OPEN EXCISIONAL HEMORRHOIDECTOMY | Active comparator | Patients will undergo conventional open excisional hemorrhoidectomy Receives: Procedure: CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY |
| MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY | Experimental | Patients will undergo open excisional hemorrhoidectomy using a minimally invasive technique Receives: Procedure: MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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..
Measured: 10 days
Secondary outcomes (2)
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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Why it stopped: It corresponds to IDEAL Framework stage 4 and now we are conducting stage 2
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Fernandez Hurtado, Hospital Son Llatzer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764849
- Sponsor's protocol ID
- IB5478/24
- Status last verified
- Aug 2025
- First submitted
- 23 Dec 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30451751
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Open Excisional Hemorrhoidectomy Compared to Conventional Open Excisional Hemorrhoidectomy: a Clinical Trial
- ClinicalTrials.gov ID
- NCT06764849
- Acronym / sponsor ID
- IB5478/24
- Keywords
- hemorrhoidal disease, minimally invasive open excisional hemorrhoidectomy, open excisional hemorrhoidectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It corresponds to IDEAL Framework stage 4 and now we are conducting stage 2
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPEN EXCISIONAL HEMORRHOIDECTOMY | Active comparator | Procedure: CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMYPatients will undergo conventional open excisional hemorrhoidectomy |
| MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY | Experimental | Procedure: MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMYPatients will undergo open excisional hemorrhoidectomy using a minimally invasive technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 18 years.
- Hemorrhoids grade III.
- Surgical indication for hemorrhoidal disease.
Key exclusion criteria (7 listed)
- Acute hemorrhoidal disease.
- Previous hemorrhoidal surgery.
- Concomitant anal fissure.
- Concomitant anal fistulae.
- Concomitant rectal prolapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMYHemorrhoidectomy performed based on the conventional technique described by Milligan-Morgan | Procedure or surgery | OPEN EXCISIONAL HEMORRHOIDECTOMY |
| MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMYHemorrhoidectomy performed based on the tecnique described by Milligan Morgan, using a minimally invasive approach. | Procedure or surgery | MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY |
Primary outcome
Postoperative pain measured with the visual analogic scale
Time frame: 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
Time frame: 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..
2 secondary outcomes
Efficacy of the treatment using the Hemorrhoidal Disease Symptom Score
Time frame: 1 year
Efficacy of treatment using the Short Health Scale adapted for hemorrhoidal disease
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 30451751Rorvik 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.
- Individual participant dataSharing planned: No
Related trials for Hemorrhoidectomy
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Not yet recruiting
Laser Hemorrhoidoplasty Versus Open Hemorrhoidectomy for Postoperative Pain
Hemorrhoid
Not yet recruitingPhase 2
Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
Hemorrhoids Internal, Hemorrhoids Second Degree
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CONVENTIONAL OPEN EXCISIONAL HEMORRHOIDECTOMY and MINIMALLY INVASIVE OPEN EXCISIONAL HEMORRHOIDECTOMY in people with Hemorrhoidectomy and Hemorrhoids Third Degree, run by Hospital Son Llatzer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain measured with the visual analogic scale (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06764849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.