Patients' Quality of Life After Pilonidal Cyst Operations.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Patients' Quality of Life and Treatment Outcomes After Pilonidal Cyst Operations.

Conditions
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Pilonidal Cyst, Pain Postoperative, Quality of Life

Intervention / Treatment
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* Procedure: Minimally invasive pit-picking surgery
* Procedure: Radical surgical excision without suturing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-75 (men and women) Chronic symptomatic (primary or recurrent) pilonidal cyst American Society of Anesthesiologists physical status I to III Signed the person's information and consent form to participate in the study. Exclusion Criteria: Acute pilonidal cyst Patients who do not speak Lithuanian Cognitive, visual, auditory and locomotor system disorders Insufficiency of kidneys, liver, cardiopulmonary system Refuses to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pit picking group<br>Minimally invasive pilonidal cyst surgery. | Procedure: Minimally invasive pit-picking surgery<br>* Midline pits and secondary fistula openings were probed to determine the direction and length of any associated sinus tracts, followed by an excision with a 3 or 5 mm punch biopsy needle, depending on the size of the pit. A 2 cm lateral incision was made parallel to the pilonidal cyst. Hair and granulations within the sinus tracts were removed, and the cyst cavity was drained through the incision. Nonabsorbable monofilament sutures were used to close the excisional wounds of the pits and secondary fistula. Once haemostasis was achieved, the wound was covered with a sterile gauze with 10 % povidone-iodine solution.<br>|
| Experimental: Excision group<br>Radical surgical pilonidal cyst excision without suturing | Procedure: Radical surgical excision without suturing<br>* Under the guidance of brilliant green, the cavity of the pilonidal cyst, along with the sinus tracts and fistulas, was marked. A symmetric elliptical incision was made to excise the pits and secondary fistula openings. The pilonidal cyst was removed from the healthy subcutaneous tissue and sacrococcygeal fascia using monopolar electrocautery. The wound was not sutured and was left open to heal by secondary intention. After haemostasis was achieved, the wound was covered with sterile gauze with 10 % povidone-iodine solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after surgery | Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain at rest on a specified 100 mm scale at the specified time. | One week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of disease recurrence | Disease recurrence will be assessed by clinical examination. | Recurrence will be assessed 6 months and 2 years after surgery | 
| Pain after surgery | Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain | One day after surgery | 
| Pain after surgery | Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain | Two days after surgery | 
| Pain after surgery | Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain | Two weeks after surgery | 
| Pain after surgery | Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain | One month after surgery | 
| Pain after surgery | Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain | Two months after surgery | 
| Pain after surgery | Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain | Six months after surgery |