Patients' Quality of Life After Pilonidal Cyst Operations.

NCT ID: NCT05982028

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2025-03-01

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.

Conditions

Pilonidal Cyst; Pain Postoperative; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pit picking group

Minimally invasive pilonidal cyst surgery.

Group Type: EXPERIMENTAL

Minimally invasive pit-picking surgery

Intervention Type: PROCEDURE

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.

Excision group

Radical surgical pilonidal cyst excision without suturing

Group Type: EXPERIMENTAL

Radical surgical excision without suturing

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Edvinas Dainius

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lithuanian University of Health Sciences, Clinic of General Surgery

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

PC1 - 4

Identifier Type: -

Identifier Source: org_study_id