Minimal Invasive SurgeryNCT07695649
Reproducibility of a Minimally Invasive Ferguson-type Hemorrhoidectomy for Grade III Hemorrhoids
An observational study of Minimal Invasive Surgery and Hemorrhoidectomy, 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
- Minimal Invasive Surgery, Hemorrhoidectomy
- What is being tested?
- Minimal invasive closed hemorrhoidectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2026to 31 Dec 2026
- 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 excisional hemorrhoidectomy 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 de Mallorca, 07190
Ignacio Fernandez-Hurtado, MD, +34 871202000 ext. 2134, ifernandez@hsll.es
About this study
Official title: Prospective Observational Study to Assess the Reproducibility of Ferguson's Minimally Invasive Hemorrhoidectomy in the Treatment of Grade III Hemorrhoids: Phase 2a of the IDEAL 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. Excisional hemorrhoidectomy is the standard procedure. There are two main options: without wound closure (Milligan-Morgan technique) and with wound closure (Ferguson technique). Both options are effective in the long term and cause severe postoperative pain, although comparative studies between Milligan-Morgan and Ferguson hemorrhoidectomy have shown that the Ferguson technique is associated with less postoperative pain and better early wound healing, while maintaining similar long-term efficacy.
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 scarcely been explored in anal surgery. Its potential advantages include reduced tissue injury and improved healing, although it entails a learning curve and may initially prolong operative time.
Read more
The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. IDEAL phase 2a focuses on the optimization and technical definition of a surgical innovation, emphasizing continuous improvement based on real clinical practice and laying the foundation for broader and more rigorous subsequent studies.
Since no previous studies on the application of MIS in closed Ferguson hemorrhoidectomy have been identified, the investigators propose a phase 2a IDEAL study to assess the reproducibility of this minimally invasive adaptation. The investigators hypothesize that incorporating MIS into the Ferguson technique could further reduce postoperative pain and accelerate recovery, while preserving the well-established effectiveness of closed hemorrhoidectomy in advanced hemorrhoidal disease.
- Conditions
- Minimal Invasive Surgery, Hemorrhoidectomy
- Being tested
- Minimal invasive closed hemorrhoidectomy
- Keywords
- hemorrhoids grade III-IV, Minimal Invasive Surgery, IDEAL stage 1, Closed hemorrhoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal invasive closed hemorrhoidectomyProcedure or surgery
We propose applying minimally invasive surgery to closed Ferguson excisional hemorrhoidectomy, the most effective technique for treating advanced hemorrhoidal disease. We believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of excisional hemorrhoidectomy. Our hypothesis is based on reduced tissue trauma, the increased precision provided by minimally invasive surgery, and secure tissue closure.
| Study group | Role | What they receive |
|---|---|---|
| Grade III-IV Hemorrhoids | Patients with symptomatic grade III-IV hemorrhoids who consent to surgical interv Receives: Procedure: Minimal invasive closed hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Reproducibility of Surgery
Since 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
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
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
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
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
Hemorrhoidal Clinical Fail Rate
It is a pragmatic composite endpoint. It is determined by assessing changes in haemorrhoidal symptoms according to the HDSS and haemorrhoidal disease-related quality of life according to the SHS-HD, comparing baseline and 1-year values. The change in haemorrhoidal symptoms is calculated using the following formula: (baseline HDSS-postoperative HDSS)/baseline HDSS×100. The change in haemorrhoidal disease-related quality of life is calculated using the following formula: (baseline SHS-HD-postoperative SHS-HD)/baseline SHS-HD×100. CFR is positive when both criteria show a reduction of at least 50%.
Measured: One postoperative year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start15 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Invasive SurgeryStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Fernandez Hurtado, Hospital Son Llatzer
- Investigators
- Ignacio Fernandez-Hurtado, MD, Principal investigator, Hospital Son Llatzer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695649
- Sponsor's protocol ID
- HEM IDEAL 2A_FERGUSON
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Assess the Reproducibility of Ferguson's Minimally Invasive Hemorrhoidectomy in the Treatment of Grade III Hemorrhoids: Phase 2a of the IDEAL Framework
- ClinicalTrials.gov ID
- NCT07695649
- Acronym / sponsor ID
- HEM IDEAL 2A_FERGUSON
- Conditions
- Minimal Invasive Surgery, Hemorrhoidectomy
- Keywords
- hemorrhoids grade III-IV, Minimal Invasive Surgery, IDEAL stage 1, Closed hemorrhoidectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jul 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. Excisional hemorrhoidectomy is the standard procedure. There are two main options: without wound closure (Milligan-Morgan technique) and with wound closure (Ferguson technique). Both options are effective in the long term and cause severe postoperative pain, although comparative studies between Milligan-Morgan and Ferguson hemorrhoidectomy have shown that the Ferguson technique is associated with less postoperative pain and better early wound healing, while maintaining similar long-term efficacy.
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 scarcely been explored in anal surgery. Its potential advantages include reduced tissue injury and improved healing, although it entails a learning curve and may initially prolong operative time.
The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. IDEAL phase 2a focuses on the optimization and technical definition of a surgical innovation, emphasizing continuous improvement based on real clinical practice and laying the foundation for broader and more rigorous subsequent studies.
Since no previous studies on the application of MIS in closed Ferguson hemorrhoidectomy have been identified, the investigators propose a phase 2a IDEAL study to assess the reproducibility of this minimally invasive adaptation. The investigators hypothesize that incorporating MIS into the Ferguson technique could further reduce postoperative pain and accelerate recovery, while preserving the well-established effectiveness of closed hemorrhoidectomy in advanced hemorrhoidal disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grade III-IV Hemorrhoids | – | Procedure: Minimal invasive closed hemorrhoidectomyPatients with symptomatic grade III-IV hemorrhoids who consent to surgical interv |
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 excisional hemorrhoidectomy 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 |
|---|---|---|
| Minimal invasive closed hemorrhoidectomyWe propose applying minimally invasive surgery to closed Ferguson excisional hemorrhoidectomy, the most effective technique for treating advanced hemorrhoidal disease. We believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of excisional hemorrhoidectomy. Our hypothesis is based on reduced tissue trauma, the increased precision provided by minimally invasive surgery, and secure tissue closure. | Procedure or surgery | Grade III-IV Hemorrhoids |
Primary outcome
Technical Reproducibility of Surgery
Time frame: 30 postoperative days
Since 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
Total number of postoperative analgesics
Time frame: 14 postoperative days
Postoperative pain
Time frame: The first 14 postoperative days
Short Health Scale in hemorrhoidal disease
Time frame: One year postoperative
Hemorrhoidal disease symptom score
Time frame: one postoperative year
Hemorrhoidal Clinical Fail Rate
Time frame: One postoperative year
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 10 Jul 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.
Ignacio Fernandez-Hurtado, MD principal investigator
Hospital Son Llatzer
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 Minimal Invasive Surgery and Hemorrhoidectomy, 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 10 Jul 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, MD (+34871202000 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 10 Jul 2026.