HemorrhoidectomyNCT07534761
Minimaly Ivnasive Surgery for Grade III Hemorrhoids
An observational study of Hemorrhoidectomy and Minimally Invasive Surgical Technique, run by Hospital Son Llatzer at 1 site in Spain.
Trial summary
Hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. Their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. In advanced cases (Goligher Grade III-IV), surgery is the only effective treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoidectomy, Minimally Invasive Surgical Technique
- What is being tested?
- Minimally Invasive hemorrhoidectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2026to 1 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients attending the Surgery Department of our Hospital
Who may be able to join
- Age over 18 years
- Grade III/IV hemorrhoids
- Indication for CEH surgery
- Signed written informed consent
Who cannot join
- Acute hemorrhoidal disease (thrombosis)
- Previous hemorrhoid surgery
- Coexistence of anal fissure
- Coexistence of perianal fistula
- Coexistence of rectal or anal prolapse
- Active inflammatory bowel disease
- Active anal or colorectal cancer
- Language barrier or difficulty in oral and/or written comprehension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Son Llatzer
Palma, Balearic Islands, 07190
Ignacio Fernandez-Hurtado, Colorectal Surgeon, +34 871 202000 ext. 2134, ifernandez@hsll.es
About this study
Official title: Prospective Observational Study to Assess the Reproducibility of Minimally Invasive Surgery in Closed Excisional Hemorrhoidectomy: Phase 2A of theI DEAL Framework
Hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. Their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. In advanced cases (Goligher Grade III-IV), surgery is the only effective treatment. Closed excisional hemorrhoidectomy (CEH), based on the Ferguson technique, is one of the standard procedures. Although effective in the long term, it causes severe postoperative pain. Minimally invasive surgery (MIS) employs enhanced visualization devices to improve surgical precision and reduce tissue damage. While widely used in specialties with small surgical fields, it has not yet been explored in anal surgery. Its advantages include reduced tissue injury and improved healing, although it presents a learning curve and an initially longer surgical time. The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. The IDEAL phase 2a is aimed at the optimization and technical definition of surgical innovation with a focus on continuous improvement based on real clinical practice, laying the foundation for broader and more rigorous subsequent studies.
Since no previous studies on the application of MIS in CEH have been found, the investigators propose a study within Stage 2A of the IDEAL model to assess the reproducibility of this technique. The investigators believe its incorporation into closed excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.
- Being tested
- Minimally Invasive hemorrhoidectomy
- Keywords
- hemorrhoids grade III-IV, Hemorrhoidectomy, IDEAL stage 2A, minimally Invasive Surgical Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive hemorrhoidectomyProcedure or surgery
The investigators propose applying minimally invasive surgery in closed excisional hemorrhoidectomy (CEH) , the most effective technique for treating advanced hemorrhoidal disease. The investigators believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of CEH. The investigator's hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery.
| Study group | Role | What they receive |
|---|---|---|
| Grade III / IV hemorrhoids | Patients with symptomatic grade III/IV hemorrhoids who consent to surgical intervention Receives: Procedure: Minimally Invasive hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Reproducibility of Surgery
ince no studies using this approach were found in the literature, the investigators propose a study to assess the reproducibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 2A. The measurement tool will be the systematic documentation of technical modifications.
Measured: 30 postoperative days
Secondary outcomes (6)
Adverse events in treated patients
Collect the adverse effects that occur during the operative period and within the first 30 postoperative days. Filter those attributable to the use of the minimally invasive approach. Analyze the causes and the technical steps that should be performed or omitted to avoid them. As measurement tools, the Clavien-Dindo scale and the Comprehensive Complication Index (CCI) will be used. The CCI is an index that uses the Clavien-Dindo scale and is calculated with a mathematical formula available at www.assessurgery.com
Measured: 30 postoperative days
Postoperative pain
Postoperative pain will be evaluated using the Visual Analogue Scale (VAS), a validated tool ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will self-assess their baseline pain and pain following defecation at predefined intervals: postoperative days 4, 7, and 14.
Measured: The first 14 postoperative days
Hemorrhoidal disease symptom score
A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome.
Measured: one postoperative year
Short Health Scale in hemorrhoidal disease
A subjective scale which defines symptom intensity, the patient's worrying and the role in impairment of daily activity. Score 4 to 28. Higher scores mean a worse outcome
Measured: One year postoperative
Total number of postoperative analgesics
The total number of analgesic doses taken by the patient during the first 14 postoperative days will be recorded as a numeric variable
Measured: 14 postoperative days
Clinical Failure Rate
Clinical failure rate (CFR) is defined by the difference in haemorrhoidal symptoms according to Haemorrhoidal Disease Symptom Score and haemorrhoidal disease-related quality of life according to Short Health Scale adapted for Haemorrhoidal Disease comparing baseline and 1-year values. This difference was calculated using the following formula: (baseline Haemorrhoidal Disease Symptom Score - postoperative Haemorrhoidal Disease Symptom Score )/ baseline Haemorrhoidal Disease Symptom Score × 100. The change in quality of life related to haemorrhoidal disease was calculated using the following formula: (baseline Short Health Scale adapted for Haemorrhoidal Disease - postoperative Short Health Scale adapted for Haemorrhoidal Disease.)/baseline Short Health Scale adapted for Haemorrhoidal Disease. × 100. CFR was positive when both criteria showed a ≤50% difference.
Measured: one year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
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
- NCT07534761
- Sponsor's protocol ID
- HEM CLOSE IDEAL 2A
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Assess the Reproducibility of Minimally Invasive Surgery in Closed Excisional Hemorrhoidectomy: Phase 2A of theI DEAL Framework
- ClinicalTrials.gov ID
- NCT07534761
- Acronym / sponsor ID
- HEM CLOSE IDEAL 2A
- Keywords
- hemorrhoids grade III-IV, Hemorrhoidectomy, IDEAL stage 2A, minimally Invasive Surgical Technique
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Apr 2026 (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.
Hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. Their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. In advanced cases (Goligher Grade III-IV), surgery is the only effective treatment. Closed excisional hemorrhoidectomy (CEH), based on the Ferguson technique, is one of the standard procedures. Although effective in the long term, it causes severe postoperative pain. Minimally invasive surgery (MIS) employs enhanced visualization devices to improve surgical precision and reduce tissue damage. While widely used in specialties with small surgical fields, it has not yet been explored in anal surgery. Its advantages include reduced tissue injury and improved healing, although it presents a learning curve and an initially longer surgical time. The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. The IDEAL phase 2a is aimed at the optimization and technical definition of surgical innovation with a focus on continuous improvement based on real clinical practice, laying the foundation for broader and more rigorous subsequent studies.
Since no previous studies on the application of MIS in CEH have been found, the investigators propose a study within Stage 2A of the IDEAL model to assess the reproducibility of this technique. The investigators believe its incorporation into closed excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grade III / IV hemorrhoids | – | Procedure: Minimally Invasive hemorrhoidectomyPatients with symptomatic grade III/IV hemorrhoids who consent to surgical intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the Surgery Department of our Hospital
Key inclusion criteria (4 listed)
- Age over 18 years
- Grade III/IV hemorrhoids
- Indication for CEH surgery
- Signed written informed consent
Key exclusion criteria (8 listed)
- Acute hemorrhoidal disease (thrombosis)
- Previous hemorrhoid surgery
- Coexistence of anal fissure
- Coexistence of perianal fistula
- Coexistence of rectal or anal 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 |
|---|---|---|
| Minimally Invasive hemorrhoidectomyThe investigators propose applying minimally invasive surgery in closed excisional hemorrhoidectomy (CEH) , the most effective technique for treating advanced hemorrhoidal disease. The investigators believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of CEH. The investigator's hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery. | Procedure or surgery | Grade III / IV hemorrhoids |
Primary outcome
Technical Reproducibility of Surgery
Time frame: 30 postoperative days
ince no studies using this approach were found in the literature, the investigators propose a study to assess the reproducibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 2A. The measurement tool will be the systematic documentation of technical modifications.
6 secondary outcomes
Adverse events in treated patients
Time frame: 30 postoperative days
Postoperative pain
Time frame: The first 14 postoperative days
Hemorrhoidal disease symptom score
Time frame: one postoperative year
Short Health Scale in hemorrhoidal disease
Time frame: One year postoperative
Total number of postoperative analgesics
Time frame: 14 postoperative days
Clinical Failure Rate
Time frame: one year postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoidectomy and Minimally Invasive Surgical Technique, run by Hospital Son Llatzer at 1 site in Spain.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Fernandez-Hurtado, Colorectal Surgeon (+34 871202000 ext. 2134, ifernandez@hsll.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Reproducibility of Surgery (time frame: 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.