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NCT Number: NCT04863963

Milligan-Morgan Versus Dearterialization With Mucopexy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antonio Giuliani

L’Aquila, AQ, 67100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Milligan Morgan

Procedure

Surgical intervention used in case of Goligher's grade III hemorrhoidal disease

Other names: Transanal dearterialization with mucopexy

Primary outcomes

  1. Rate of complications

    Time frame: 24 months

    Compare surgical techniques in terms of complications

  2. Effectiveness

    Time frame: 24 months

    Compare surgical techniques in terms of effectiveness (persistence / reappearance of symptoms and recurrences).

  3. Speed in functional recovery

    Time frame: 24 months

    Compare surgical techniques in terms of functional recovery

  4. 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

Secondary outcomes

  1. Surgical device

    Time frame: 24 months

    Analyze the surgical devices used

  2. Type of anesthesia

    Time frame: 24 months

    Evaluate the type of anesthesia choiced

  3. Hospitalization times

    Time frame: 24 months

    Evaluate and compare hospitalization times

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Aquila

Other

Registry information

Official study title

Milligan-Morgan Hemorrhoidectomy Versus Dearterialization With Mucopexy in the Treatment of Grade III Hemorrhoidal Disease: Multicenter Retrospective Study

Acronym: EMODART3

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2021
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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