Patients' Quality of Life After Pilonidal Cyst Operations.

• ClinicalTrials.gov Identifier: NCT05982028
• Recruitment Status: Enrolling by invitation
• First Posted: August 8, 2023
• Last Update Posted: August 8, 2023
• Sponsor: Lithuanian University of Health Sciences
• Information provided by (Responsible Party): Edvinas Dainius, Lithuanian University of Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pilonidal Cyst; Pain Postoperative; Quality of Life	Procedure: Minimally invasive pit-picking surgery; Procedure: Radical surgical excision without suturing	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Patients' Quality of Life and Treatment Outcomes After Pilonidal Cyst Operations.
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: September 1, 2024
• Estimated Study Completion Date: March 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Pain after surgery [ Time Frame: One week 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.

Secondary Outcome Measures :

1. Rate of disease recurrence [ Time Frame: Recurrence will be assessed 6 months and 2 years after surgery ]
   Disease recurrence will be assessed by clinical examination.
2. Pain after surgery [ Time Frame: One day after surgery ]
   Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
3. Pain after surgery [ Time Frame: Two days after surgery ]
   Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
4. Pain after surgery [ Time Frame: Two weeks after surgery ]
   Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
5. Pain after surgery [ Time Frame: One month after surgery ]
   Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
6. Pain after surgery [ Time Frame: Two months after surgery ]
   Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
7. Pain after surgery [ Time Frame: Six months after surgery ]
   Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain

Other Outcome Measures:

1. Postoperative complications [ Time Frame: 1 months after surgery ]
   Patients will report past complications.
2. Quality of life according to the 36-Item Short Form Survey (SF-36). [ Time Frame: 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. ]
   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.
3. Duration of disability [ Time Frame: 1 month after surgery ]
   Patients will note the duration of incapacity for work.
4. Wound healing time [ Time Frame: Six months after surgery ]
   Patients will note the time when the wound healed.
5. Quality of life total scores according to a specific life questionnaire developed by the researcher. [ Time Frame: 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. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Lithuania

Lithuanian University of Health Sciences, Clinic of General Surgery

Kaunas, Lithuania, LT-47144

Sponsors and Collaborators

Lithuanian University of Health Sciences

More Information

• Responsible Party: Edvinas Dainius, Principal Investigator, Lithuanian University of Health Sciences
• ClinicalTrials.gov Identifier: NCT05982028
• Other Study ID Numbers: PC1 - 4
• First Posted: August 8, 2023
• Last Update Posted: August 8, 2023
• Last Verified: July 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cysts; Pilonidal Sinus; Pain, Postoperative; Neoplasms; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations