Clinical trial NCT04863963: Milligan-Morgan Versus Dearterialization With Mucopexy
Official title: Milligan-Morgan Hemorrhoidectomy Versus Dearterialization With Mucopexy in the Treatment of Grade III Hemorrhoidal Disease: Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhoids
Hemorrhoid Prolapse
Keywords: Hemorrhoids
Milligan- Morgan
Mucopexy
Lead sponsor: Università degli Studi dell'Aquila
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of complications
timeFrame: 24 months
measure: Effectiveness
timeFrame: 24 months
measure: Speed in functional recovery
timeFrame: 24 months
measure: Rate of choice of the two techniques
timeFrame: 24 months
Secondary outcomes:
measure: Surgical device
timeFrame: 24 months
measure: Type of anesthesia
timeFrame: 24 months
measure: Hospitalization times
timeFrame: 24 months
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Antonio Giuliani
state: AQ
Study officials:
References: