Milligan-Morgan Versus Dearterialization With Mucopexy
EMODART3
Milligan-Morgan Hemorrhoidectomy Versus Dearterialization With Mucopexy in the Treatment of Grade III Hemorrhoidal Disease: Multicenter Retrospective Study
1 other identifier
observational
1,000
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2021
CompletedFirst Posted
Study publicly available on registry
April 28, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2021
CompletedSeptember 28, 2021
September 1, 2021
3 months
April 23, 2021
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Rate of complications
Compare surgical techniques in terms of complications
24 months
Effectiveness
Compare surgical techniques in terms of effectiveness (persistence / reappearance of symptoms and recurrences).
24 months
Speed in functional recovery
Compare surgical techniques in terms of functional recovery
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
24 months
Secondary Outcomes (3)
Surgical device
24 months
Type of anesthesia
24 months
Hospitalization times
24 months
Study Arms (2)
Milligan Morgan
Patients 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
Interventions
Surgical intervention used in case of Goligher's grade III hemorrhoidal disease
Eligibility Criteria
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.
You may qualify if:
- ≥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.
You may not qualify if:
- Recurrent disease
- bleeding disorders
- chronic inflammatory bowel diseases
- vasculopathies
- combined surgical techniques (HAL with mucopexy and removal of one or more haemorrhoidal nodules)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antonio Giuliani
L’Aquila, AQ, 67100, Italy
Related Publications (1)
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.
PMID: 37616177DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 23, 2021
First Posted
April 28, 2021
Study Start
July 1, 2021
Primary Completion
September 15, 2021
Study Completion
September 25, 2021
Last Updated
September 28, 2021
Record last verified: 2021-09