Milligan-Morgan Hemorrhoidectomy Versus Dearterialization With Mucopexy in the Treatment of Grade III Hemorrhoidal Disease: Multicenter Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Speed in functional recovery
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥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.
Exclusion Criteria
- •Recurrent disease
- •bleeding disorders
- •chronic inflammatory bowel diseases
- •vasculopathies
- •combined surgical techniques (HAL with mucopexy and removal of one or more haemorrhoidal nodules)
Outcomes
Primary Outcomes
Speed in functional recovery
Time Frame: 24 months
Compare surgical techniques in terms of functional recovery
Rate of complications
Time Frame: 24 months
Compare surgical techniques in terms of complications
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
Effectiveness
Time Frame: 24 months
Compare surgical techniques in terms of effectiveness (persistence / reappearance of symptoms and recurrences).
Secondary Outcomes
- Type of anesthesia(24 months)
- Hospitalization times(24 months)
- Surgical device(24 months)
Investigators
Lucia Romano
Principal Investigator
Università degli Studi dell'Aquila