MPFF for hemorrhoids undergoing minimally invasive procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study in real-world clinical practice. It records how MPFF is used alongside standard care for adults with grade 2–3 chronic hemorrhoids undergoing laser, dearterialization, or combined procedures. The study does not require changes to usual treatment decisions and follows existing guidelines and medical-use instructions. Data collected include treatment details, quality of life, satisfaction, and any changes in therapy as determined by the treating physician. The aim is to see how MPFF affects outcomes in routine care, not to test a new experimental intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males and females aged over 18 years.
* Informing the patient in writing about the inclusion in the study and his/her consent to participate in it.
* Absence of conditions requiring urgent medical care.
* The patient was diagnosed with chronic hemorrhoids of grade 2 or 3 according to Goligher classification.
* The patient is scheduled to undergo one of the listed types of minimally invasive surgical treatment within 7 ± 2 days from the inclusion in the study (V0):
* laser vaporization (laser submucosal destruction or ablation);
* transanal dearterialization (hemorrhoidal artery ligation);
* transanal dearterialization + laser vaporization (laser submucosal destruction or ablation);
* transanal dearterialization + sclerotherapy.
* No venoactive drug treatment within 4 weeks prior to inclusion in the study.
* The patient has been prescribed with MPFF at the inclusion visit, or it is planned to prescribe MPFF-containing drug in the postoperative period (for cluster 1 sites), or the patient has not been prescribed with any systemic venoactive drug, and it is not planned to prescribe it the postoperative period (for cluster 2 sites).\*

Exclusion Criteria:

* Pregnancy or breast-feeding, or planning for pregnancy during the study or at least in two months after its completion.
* Confirmed or suspected malignancy.
* Severe somatic disorder (of heart or blood vessels, lungs, kidneys, pancreas, or liver), accompanied by the organ function decompensation.
* Mental disorder.
* Contraindications for examination.
* Predicted unwillingness of the patient to follow the protocol of treatment and supervision, poor adherence to treatment.
* Patient's participation in any interventional/observational study at the present time.
* Patients who received venoactive drugs in the 4 weeks prior to Visit 0 (inclusion visit).

Where it's running

• GBUZ hospital
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Ivan KOSTAREV — A.N. Ryzhikh National Medical Research Center of Proctology
• Study coordinator: Olga Linnik
• Email: olga.linnik@servier.com
• Phone: 495 9370700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.