HemorrhoidsEMODART3NCT04863963
Milligan-Morgan Versus Dearterialization With Mucopexy
An observational study of Hemorrhoids and Hemorrhoid Prolapse, run by Università degli Studi dell'Aquila at 1 site in Italy.
Trial summary
Nowadays, there are several methods that can be used for grade III hemorrhoidal disease, according to Goligher classificiation. Milligan Morgan hemorrhoidectomy is considered the most effective treatment in many centers, even if characterized by marked postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhoids, Hemorrhoid Prolapse
- What is being tested?
- Milligan Morgan
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 25 Sep 2021
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be of a multicentre observational retrospective type. Any Italian Center belonging to the Italian Society of Colorectal Surgery (SICCR) in which at least 30 procedures are performed per year for haemorrhoidal disease can participate. The study will include patients treated with the aforementioned methods in the period including the 4 years prior to the adhesion of the center to the survey. All patients aged ≥18 years-old, with Goligher's grade III haemorrhoidal disease can be included in the study, who underwent elective Doppler-guided or non-Doppler guided HAL surgery associated with mucopexy or Milligan-Morgan hemorrhoidectomy.
Who may be able to join
- ≥18 years-old
- Goligher's grade III haemorrhoidal disease
- indication to elective Doppler-guided or non-Doppler guided HAL surgery associated with mucopexy or Milligan-Morgan hemorrhoidectomy.
Who cannot join
- Recurrent disease
- bleeding disorders
- chronic inflammatory bowel diseases
- vasculopathies
- combined surgical techniques (HAL with mucopexy and removal of one or more haemorrhoidal nodules)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Milligan-Morgan Hemorrhoidectomy Versus Dearterialization With Mucopexy in the Treatment of Grade III Hemorrhoidal Disease: Multicenter Retrospective Study
Nowadays, there are several methods that can be used for grade III hemorrhoidal disease, according to Goligher classificiation. Milligan Morgan hemorrhoidectomy is considered the most effective treatment in many centers, even if characterized by marked postoperative pain. Among the minimally invasive alternative procedures, the transanal hemorrhoidal dearterialization (HAL - ligation of the hemorrhoidal artery) Doppler-guided or without Doppler, associated with mucopexy, seems to gain success, with promising results but still awaiting high-grade scientific evidence.
On the basis of this background, we decided to carry out a multi-center survey on a national scale, retrospectively including patients diagnosed with Goligher's grade III hemorrhoidal disease, surgically treated with hemorrhoidectomy or dearterialization.
Read the detailed description
The study will be of a multicentre observational retrospective type. Any Italian Center belonging to the Italian Society of Colorectal Surgery (SICCR) in which at least 30 procedures are performed per year for haemorrhoidal disease can join the study. Each Center must identify a Head of the study and a maximum of 2 collaborators. Each Center participating in the Study will be provided with a data collection sheet for completion. The information regarding the follow-up may come from a telephone survey or an outpatient clinical visit. In both cases, the patient will be asked to express informed consent by filling in the form attached to the information sheet.
The study will include patients treated with the analysed methods (Milligan Morgan or hemorrhoidal dearterialization) in the period comprising the 4 years prior to the adhesion of the center to the survey.
Patients included in the study will need to have at least 24 months of follow-up.
Given the inevitable effects of the SARS-CoV-2 pandemic on surgical and outpatient activities, the study period is considered valid until February 2020. Data regarding surgery or follow-up after March 2020 will not be included in analyzes.
The participation of 435 patients for each group is expected (870 total patients) considering a power of 80%, of which at least 50 in this facility, over the age of 18.
Clinical recovery is defined as the disappearance of the proctological symptoms reported by the patient (post-operative symptom score equal to 0).
Instead, anatomical healing is defined as the absence of haemorrhoidal pathology on objective examination (maximum Gholigher's grade 1).
Relapse is defined as the persistence or reappearance of the reported symptoms and the finding on physical examination of hemorrhoidal disease of a degree equal to or higher than the assessment attributed during the preoperative examination.
The physical examination is conducted by the same medical staff who made the diagnosis.
Symptoms will be assessed using the symptom score system proposed by Giordano et al., according to which the patient is asked to assign a score to each parameter evaluated, ranging from 0 (absence of symptoms) to 4 (daily symptoms or at each evacuation). The parameters evaluated are bleeding, prolapse, the need for manual reduction, pain or discomfort and the impact on quality of life. An overall score of 0 corresponds to the total absence of symptoms, while an overall score of 20 indicates the worst possible symptomatology.
The patient will be asked to assign a score to the symptoms present before the surgery and therefore 24 months after the same.
According to the data in the literature, the following factors could be associated with a higher risk of relapse: female sex, presence of associated mucosal prolapse.
- Conditions
- Hemorrhoids, Hemorrhoid Prolapse
- Being tested
- Milligan Morgan
- Keywords
- Hemorrhoids, Milligan- Morgan, Mucopexy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milligan MorganProcedure or surgery
Also called Transanal dearterialization with mucopexy
Surgical intervention used in case of Goligher's grade III hemorrhoidal disease
| Study group | Role | What they receive |
|---|---|---|
| Milligan Morgan | Patients aged ≥18 years-old, with Goligher's grade III haemorrhoidal disease, who underwent elective Milligan-Morgan hemorrhoidectomy surgery. Receives: Procedure: Milligan Morgan | |
| Dearterialization with mucopexy | Patients aged ≥18 years-old, with Goligher's grade III haemorrhoidal disease, who underwent elective Doppler-guided or non-Doppler guided HAL surgery associated with mucopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complications
Compare surgical techniques in terms of complications
Measured: 24 months
Effectiveness
Compare surgical techniques in terms of effectiveness (persistence / reappearance of symptoms and recurrences).
Measured: 24 months
Speed in functional recovery
Compare surgical techniques in terms of functional recovery
Measured: 24 months
Rate of choice of the two techniques
Evaluate the rate of choice in Italy of the two different surgical techniques (HAL THD with mucopexy and Milligan Morgan hemorrhoidectomy) for the treatment of Golighers's grade III hemorrhoidal disease
Measured: 24 months
Secondary outcomes (3)
Surgical device
Analyze the surgical devices used
Measured: 24 months
Type of anesthesia
Evaluate the type of anesthesia choiced
Measured: 24 months
Hospitalization times
Evaluate and compare hospitalization times
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Jul 2021
- Primary completion15 Sep 2021
- Study completion25 Sep 2021
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 HemorrhoidsStudies 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
- Other
- Enrolment
- 1,000 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Romano, Università degli Studi dell'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863963
- Sponsor's protocol ID
- Observational
- Acronym
- EMODART3
- Status last verified
- Sep 2021
- First submitted
- 23 Apr 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giuliani A, Romano L, Necozione S, Cofini V, Di Donato G, Schietroma M, Carlei F; EMODART3 Study Group. Excisional Hemorrhoidectomy Versus Dearterialization With Mucopexy for the Treatment of Grade III Hemorrhoidal Disease: The EMODART3 Multicenter Study. Dis Colon Rectum. 2023 Dec 1;66(12):e1254-e1263. doi: 10.1097/DCR.0000000000002885. Epub 2023 Aug 24.
PubMed 37616177
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milligan-Morgan Hemorrhoidectomy Versus Dearterialization With Mucopexy in the Treatment of Grade III Hemorrhoidal Disease: Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT04863963
- Acronym / sponsor ID
- EMODART3 / Observational
- Conditions
- Hemorrhoids, Hemorrhoid Prolapse
- Keywords
- Hemorrhoids, Milligan- Morgan, Mucopexy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Università degli Studi dell'AquilaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 25 Sep 2021 (actual)
- First posted
- 28 Apr 2021 (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.
Nowadays, there are several methods that can be used for grade III hemorrhoidal disease, according to Goligher classificiation. Milligan Morgan hemorrhoidectomy is considered the most effective treatment in many centers, even if characterized by marked postoperative pain. Among the minimally invasive alternative procedures, the transanal hemorrhoidal dearterialization (HAL - ligation of the hemorrhoidal artery) Doppler-guided or without Doppler, associated with mucopexy, seems to gain success, with promising results but still awaiting high-grade scientific evidence.
On the basis of this background, we decided to carry out a multi-center survey on a national scale, retrospectively including patients diagnosed with Goligher's grade III hemorrhoidal disease, surgically treated with hemorrhoidectomy or dearterialization.
Detailed description
The study will be of a multicentre observational retrospective type. Any Italian Center belonging to the Italian Society of Colorectal Surgery (SICCR) in which at least 30 procedures are performed per year for haemorrhoidal disease can join the study. Each Center must identify a Head of the study and a maximum of 2 collaborators. Each Center participating in the Study will be provided with a data collection sheet for completion. The information regarding the follow-up may come from a telephone survey or an outpatient clinical visit. In both cases, the patient will be asked to express informed consent by filling in the form attached to the information sheet.
The study will include patients treated with the analysed methods (Milligan Morgan or hemorrhoidal dearterialization) in the period comprising the 4 years prior to the adhesion of the center to the survey.
Patients included in the study will need to have at least 24 months of follow-up.
Given the inevitable effects of the SARS-CoV-2 pandemic on surgical and outpatient activities, the study period is considered valid until February 2020. Data regarding surgery or follow-up after March 2020 will not be included in analyzes.
The participation of 435 patients for each group is expected (870 total patients) considering a power of 80%, of which at least 50 in this facility, over the age of 18.
Clinical recovery is defined as the disappearance of the proctological symptoms reported by the patient (post-operative symptom score equal to 0).
Instead, anatomical healing is defined as the absence of haemorrhoidal pathology on objective examination (maximum Gholigher's grade 1).
Relapse is defined as the persistence or reappearance of the reported symptoms and the finding on physical examination of hemorrhoidal disease of a degree equal to or higher than the assessment attributed during the preoperative examination.
The physical examination is conducted by the same medical staff who made the diagnosis.
Symptoms will be assessed using the symptom score system proposed by Giordano et al., according to which the patient is asked to assign a score to each parameter evaluated, ranging from 0 (absence of symptoms) to 4 (daily symptoms or at each evacuation). The parameters evaluated are bleeding, prolapse, the need for manual reduction, pain or discomfort and the impact on quality of life. An overall score of 0 corresponds to the total absence of symptoms, while an overall score of 20 indicates the worst possible symptomatology.
The patient will be asked to assign a score to the symptoms present before the surgery and therefore 24 months after the same.
According to the data in the literature, the following factors could be associated with a higher risk of relapse: female sex, presence of associated mucosal prolapse.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milligan Morgan | – | Procedure: Milligan MorganPatients aged ≥18 years-old, with Goligher's grade III haemorrhoidal disease, who underwent elective Milligan-Morgan hemorrhoidectomy surgery. |
| Dearterialization with mucopexy | – | –Patients aged ≥18 years-old, with Goligher's grade III haemorrhoidal disease, who underwent elective Doppler-guided or non-Doppler guided HAL surgery associated with mucopexy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be of a multicentre observational retrospective type. Any Italian Center belonging to the Italian Society of Colorectal Surgery (SICCR) in which at least 30 procedures are performed per year for haemorrhoidal disease can participate. The study will include patients treated with the aforementioned methods in the period including the 4 years prior to the adhesion of the center to the survey. All patients aged ≥18 years-old, with Goligher's grade III haemorrhoidal disease can be included in the study, who underwent elective Doppler-guided or non-Doppler guided HAL surgery associated with mucopexy or Milligan-Morgan hemorrhoidectomy.
Key inclusion criteria (3 listed)
- ≥18 years-old
- Goligher's grade III haemorrhoidal disease
- indication to elective Doppler-guided or non-Doppler guided HAL surgery associated with mucopexy or Milligan-Morgan hemorrhoidectomy.
Key exclusion criteria (5 listed)
- Recurrent disease
- bleeding disorders
- chronic inflammatory bowel diseases
- vasculopathies
- combined surgical techniques (HAL with mucopexy and removal of one or more haemorrhoidal nodules)
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 |
|---|---|---|
| Milligan MorganAlso: Transanal dearterialization with mucopexySurgical intervention used in case of Goligher's grade III hemorrhoidal disease | Procedure or surgery | Milligan Morgan |
Primary outcome
Rate of complications
Time frame: 24 months
Compare surgical techniques in terms of complications
Effectiveness
Time frame: 24 months
Compare surgical techniques in terms of effectiveness (persistence / reappearance of symptoms and recurrences).
Speed in functional recovery
Time frame: 24 months
Compare surgical techniques in terms of functional recovery
Rate of choice of the two techniques
Time frame: 24 months
Evaluate the rate of choice in Italy of the two different surgical techniques (HAL THD with mucopexy and Milligan Morgan hemorrhoidectomy) for the treatment of Golighers's grade III hemorrhoidal disease
3 secondary outcomes
Surgical device
Time frame: 24 months
Type of anesthesia
Time frame: 24 months
Hospitalization times
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 37616177Giuliani A, Romano L, Necozione S, Cofini V, Di Donato G, Schietroma M, Carlei F; EMODART3 Study Group. Excisional Hemorrhoidectomy Versus Dearterialization With Mucopexy for the Treatment of Grade III Hemorrhoidal Disease: The EMODART3 Multicenter Study. Dis Colon Rectum. 2023 Dec 1;66(12):e1254-e1263. doi: 10.1097/DCR.0000000000002885. Epub 2023 Aug 24.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemorrhoids and Hemorrhoid Prolapse, run by Università degli Studi dell'Aquila at 1 site in Italy.
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 5 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: finished, as of the sponsor's last update on 28 Sep 2021. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of complications (time frame: 24 months). The study lists 4 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 NCT04863963, 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 28 Sep 2021.