Patients' Quality of Life After Pilonidal Cyst Operations.

Lithuanian University of Health Sciences

Status: Invitation-only

Conditions: Pilonidal Cyst; Quality of Life; Pain Postoperative

Treatments: Procedure: Minimally invasive pit-picking surgery; Procedure: Radical surgical excision without suturing

Study type: Interventional

Funder types: Other

Identifiers

NCT05982028

PC1 - 4

Details and patient eligibility

About

Biomedical research consists of two main parts. In the first part, the pilonidal cyst-specific quality of life questionnaire is compiled, adapted, validated, tested for suitability in assessing patients after pilonidal cyst operations.

The second part will compare two pilonidal cyst operations. A prospective, comparative, randomized clinical study will be conducted.

Full description

The first part includes the creation, adaptation, validity and suitability of the pilonidal cyst-specific quality of life questionnaire in assessing patients after pilonidal cyst operations, verification and evaluation of the quality of life and its dynamics after these operations. A survey of patients operated on for acute and chronic pilonidal cysts will be conducted. The main evaluation criteria of the first part will be the internal consistency of the questionnaire, the stability of the measurements, the construct validity and the frequency of patients with moderate and severe symptoms according to the specific quality of life questionnaire after pilonidal cyst surgery and the SF36v2 quality of life questionnaire.

The second part will compare two pilonidal cyst operations. A prospective, comparative, randomized clinical study will be conducted. This part of the study will study patients scheduled for surgery for chronic pilonidal cyst. Patients will be randomized into two groups, a group that will undergo radical excision of the pilonidal cyst without suturing the wound and a group that will undergo minimally invasive "pit picking" surgery. Patients will be interviewed before surgery, as well as on the first and second day after surgery. Discharged patients will complete quality-of-life questionnaires at 1, 2 weeks, and 2 months. Patients will be invited for a visit after 1 and 6 months, wound healing, disease recurrence and quality of life will be evaluated. The main evaluation criteria of the second part will be objective data - postoperative complications, wound healing time, duration of incapacity for work, frequency of disease recurrence and subjective data - changes in pain (VAS 10 cm scale) and quality of life total points according to SF36v2 and the specific life questionnaire created after radical pilonidal cyst excision and "pit picking" operations.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18-75 (men and women)
2. Chronic symptomatic (primary or recurrent) pilonidal cyst
3. American Society of Anesthesiologists physical status I to III
4. Signed the person's information and consent form to participate in the study.

Exclusion criteria

1. Acute pilonidal cyst
2. Patients who do not speak Lithuanian
3. Cognitive, visual, auditory and locomotor system disorders
4. Insufficiency of kidneys, liver, cardiopulmonary system
5. Refuses to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pit picking group

Experimental group

Description:

Minimally invasive pilonidal cyst surgery.

Treatment:

Procedure: Minimally invasive pit-picking surgery

Excision group

Experimental group

Description:

Radical surgical pilonidal cyst excision without suturing

Treatment:

Procedure: Radical surgical excision without suturing