Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04863963 |
| Other study ID # |
Observational |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
September 25, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Università degli Studi dell'Aquila |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
