Patients' Quality of Life After Pilonidal Cyst Operations.

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Quality of Life; Pilonidal Cyst; Pain Postoperative
• Intervention / Treatment: Procedure: Minimally invasive pit-picking surgery; Procedure: Radical surgical excision without suturing

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania, LT-47144
    • Lithuanian University of Health Sciences, Clinic of General Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pit picking group; Minimally invasive pilonidal cyst surgery.	Procedure: Minimally invasive pit-picking surgery; 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.
Experimental: Excision group; Radical surgical pilonidal cyst excision without suturing	Procedure: Radical surgical excision without suturing; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Patients will report past complications.	1 months after surgery
Quality of life according to the 36-Item Short Form Survey (SF-36).	Patients fill out the the 36-Item Short Form Survey (SF-36). All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table. The scores from those questions that address each specific area of functional health status are then averaged together, for a final score within each of the 8 dimensions measured (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/ fatigue, emotional well being, social functioning, pain, general health). All 8 categories are scored in the same way.	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.
Duration of disability	Patients will note the duration of incapacity for work.	1 month after surgery
Wound healing time	Patients will note the time when the wound healed.	Six months after surgery
Quality of life total scores according to a specific life questionnaire developed by the researcher.	Patients fill out a specific life questionnaire. This questionnaire consists of 20 questions, the value of each question is from 1 to 5 points. The minimum score value is 20, the maximum score value is 100. A lower score value indicates a better quality of life.	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.

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 15, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Pain, Postoperative; Cysts; Pilonidal Sinus
• Other Study ID Numbers: PC1 - 4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No