Clinical trial NCT05982028: Patients' Quality of Life After Pilonidal Cyst Operations.
Official title: Evaluation of Patients' Quality of Life and Treatment Outcomes After Pilonidal Cyst Operations.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pilonidal Cyst
Pain Postoperative
Quality of Life
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Pain after surgery
timeFrame: One week after surgery
Secondary outcomes:
measure: Rate of disease recurrence
timeFrame: Recurrence will be assessed 6 months and 2 years after surgery
measure: Pain after surgery
timeFrame: One day after surgery
measure: Pain after surgery
timeFrame: Two days after surgery
measure: Pain after surgery
timeFrame: Two weeks after surgery
measure: Pain after surgery
timeFrame: One month after surgery
measure: Pain after surgery
timeFrame: Two months after surgery
measure: Pain after surgery
timeFrame: Six months after surgery
Other outcomes:
measure: Postoperative complications
timeFrame: 1 months after surgery
measure: Quality of life according to the 36-Item Short Form Survey (SF-36).
timeFrame: Before surgery, 1 and 2 days after surgery, 1 and 2 weeks after surgery, 1, 2 and 6 months after surgery. Change from baseline in quality of life scores over a 6-month period will be assessed.
measure: Duration of disability
timeFrame: 1 month after surgery
measure: Wound healing time
timeFrame: Six months after surgery
measure: Quality of life total scores according to a specific life questionnaire developed by the researcher.
timeFrame: Before surgery, 1 and 2 days after surgery, 1 and 2 weeks after surgery, 1, 2 and 6 months after surgery. Change from baseline in quality of life scores over a 6-month period will be assessed.
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences, Clinic of General Surgery
Study officials:
References: