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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhoids; Hemorrhoid Prolapse
• Intervention / Treatment: Procedure: Milligan Morgan

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Italy
  • AQ
    • L'Aquila, AQ, Italy, 67100
      • Antonio Giuliani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Milligan Morgan; Patients aged ≥18 years-old, with Goligher's grade III haemorrhoidal disease, who underwent elective Milligan-Morgan hemorrhoidectomy surgery.	Procedure: Milligan Morgan; Surgical intervention used in case of Goligher's grade III hemorrhoidal disease; Other Names: Transanal dearterialization with mucopexy
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical device	Analyze the surgical devices used	24 months
Type of anesthesia	Evaluate the type of anesthesia choiced	24 months
Hospitalization times	Evaluate and compare hospitalization times	24 months

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Aquila

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 25, 2021

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Hemorrhoids; Milligan- Morgan; Mucopexy
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Prolapse; Hemorrhoids
• Other Study ID Numbers: Observational

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No