Clinical Research Directory

The Impact of Perianal Disease on Patient's Sex Life

Perianal diseases, such as perianal abcesses, anal fistulae and perianal Crohn's disease, are often associated with significant physical symptoms, including pain and chronic drainage. However, the impact of these conditions on a patient's personal life, intimacy, and body image-often referred to as "hidden morbidity"-is frequently overlooked in clinical practice. The purpose of this prospective observational study is to evaluate the psychosexual burden in patients suffering from chronic perianal disease. Using validated tools (IIEF-5 for men, FSFI-6 for women) and a specialized Supplemental Patient-Reported Outcome Measure (PROM), researchers will investigate how the presence of surgical devices (such as setons), disease etiology, and clinical symptoms affect sexual function and self-esteem. The study also aims to identify gaps in physician-patient communication regarding sexual health. By quantifying these impacts, the study seeks to promote a more holistic, patient-centered approach to the surgical management of perianal conditions.

Effect of Different Sitz Bath Methods on Perianal Abscess After Surgery

Perianal abscess is a purulent infection of the tissues surrounding the anal canal and rectum. The postoperative wound is prone to infection, and the literature indicates that hip bathing is helpful to prevent infection, reduce edema, and promote healing. Therefore, patients need to use a bidet for medical sitz bath to avoid infection and contamination. The bidet on the market is divided into ordinary type and rinse type (manual or electric). There are no high-quality studies comparing the effects of these sitz baths. A prospective randomized controlled trial was designed to investigate the effects of regular sitz bath, manual irrigation, and electric irrigation. A total of 102 patients with perianal abscess in the Affiliated Hospital of Putian University were included in the study. The patients were 18-75 years old and underwent surgical treatment. Patients with recurrent abscess, anal fistula, mental disease, pregnant or lactating women, and diabetes were excluded. The patients were divided into general group, manual group and electric group by random number table method, with 34 cases in each group. All patients received hip bathing with 0.02% potassium permanganate solution at 41-43 ° C three times a day for 10-15 minutes each time after surgery.

Effect of Red and Blue Light Irradiation on Postoperative Wound Healing in Perianal Absces

This study aims to investigate whether specialized red-blue light irradiation facilitates faster postoperative recovery and reduces complication rates in patients following perianal abscess surgery. A total of 222 eligible patients were randomly allocated equally into three groups (74 per group):①Routine Care Group: Standard wound care including cleansing and dressing changes；②Red Light Therapy Group: Routine care plus red light phototherapy；③Combined Red-Blue Light Therapy Group: Routine care plus concurrent red and blue light phototherapy.Wound healing time and incidence of complications were compared to assess postoperative recovery across interventions. The primary hypothesis posits that adjunctive phototherapy-particularly combined red-blue light irradiation-will significantly enhance wound healing, reduce edema and pain, and decrease complication rates (e.g.bleeding, urinary retention) compared to routine care alone.

Machine Learning-Based Risk Stratification for Fistula Formation After Perianal Abscess Drainage

This prospective cohort study investigates the influence of provider experience and drainage location on fistula formation within 6 months following perianal abscess drainage. Additionally, the study explores the role of artificial intelligence (AI)-based interpretation of magnetic resonance (MR) images in early identification of fistula development.

Semiflex Assisted Vacuum Therapy for Perianal Abscesses/Sinuses and Fistula: a Pilot Study

Rationale: Perianal fistulas are a common, invalidating problem for which a more effective and widely applicable treatment is necessary. Vacuum therapy has become one of the main pillars for management of a wide variety of (chronic) wound healing problems. A novel catheter set was developed for vacuum therapy of perianal abscesses/sinuses and fistulas: The Semiflex Dome System. This system will allow for a better and faster treatment and it will offer conformability with various fistula shapes and sizes. Objective: With this pilot study, the investigators aim to test our novel catheter set for vacuum therapy of perianal abscesses/sinuses and fistulas for feasibility and efficacy. Study design: The design of this prospective, multicentre study is a feasibility study. Study population: Patients (≥ 18 years) with (Crohn's) perianal fistulas and patients with perianal abscesses/sinuses are eligible. Intervention: A tailored (length and diameter) Semiflex dome catheter is inserted under general anaesthesia, after 6 weeks of seton drainage in patients with a perianal fistula and right away in patients with a perianal abscess/sinus. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew) and is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. After two - three days the catheter will be exchanged by a shorter catheter in the outpatient setting. The therapy is continued for a maximum of four weeks in patients with a perianal abscess/sinus and two weeks in patients with perianal fistulas. Main study parameters/endpoints: The primary objective of the study is the feasibility of the methodology with respect to smoothness of insertion and changing the semiflex catheters, capability of proper fixation of the catheter and maintaining vacuum for more than 48 hours, and compliance to the therapy in terms of pain and discomfort. Secondary objectives are efficacy of drainage of the perianal abscess/sinus, efficacy of curing the perianal abscess/sinus in terms of complete collapse of the sinus and disappearance of induration, efficacy of management of perianal fistula in terms of clinical and radiological healing, and safety in terms of complications. Nature and extent of the burden and risks associated with participation: The Semiflex Dome Catheter System will be placed in patients with perianal fistulas and perianal abscess/sinus who would otherwise be treated using prior-art passive drainage catheters or repurposed vacuum-assisted closure therapy sponges. There are no known additional risks stemming from the proposed therapy. The Semiflex Dome Catheter System is made entirely of medical-grade silicone certified with ISO 10993- 05 and ISO 10993-10. The catheters will be connected with a tube configured to be connected to a CE certified vacuum generating system. Sample size: Since this is a pilot study no sample size is required. The pilot study will consist of 2 parts. In the first part, 10 patients in each study group will be included and it will be assessed per study group if the catheter meets the proof of principle. After a positive result in one or both study groups, the second part of the study will start. 10 patients in each study group will be included. The proposed treatment protocol is considered feasible if at least 70% of the Semiflex dome catheter treatment per study group meets the four primary objectives.

Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. After surgical intervention complications can occur with recidivism, chronic fistulas that go from the anal to the skin and sometimes the anal sphincter is damaged which can cause problems with incontinence. Through ultrasound the abscess is opened under more controlled forms with a better visual overview. This is a new technique that has not been tested in larger studies. The aim with ultrasound-drainage as with traditional incision to drain the abscess so that the infected area can heal. The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D ultrasonography.