Patients' Quality of Life After Pilonidal Cyst Operations.

Trial Title: Patients' Quality of Life After Pilonidal Cyst Operations.

NCT ID: NCT05982028

Condition: Pilonidal Cyst
Pain Postoperative
Quality of Life

Conditions: Official terms:
Cysts
Pilonidal Sinus
Pain, Postoperative

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Minimally invasive pit-picking surgery
Description: 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.
Arm group label: Pit picking group

Intervention type: Procedure
Intervention name: Radical surgical excision without suturing
Description: 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.
Arm group label: Excision group

Summary: 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: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Lithuanian University of Health Sciences, Clinic of General Surgery

Address:
City: Kaunas
Zip: LT-47144
Country: Lithuania

Start date: September 1, 2020

Completion date: March 1, 2025

Lead sponsor:
Agency: Lithuanian University of Health Sciences
Agency class: Other

Source: Lithuanian University of Health Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05982028