Pilonidal CystNCT05982028
Patients' Quality of Life After Pilonidal Cyst Operations.
A study testing Minimally invasive pit-picking surgery and Radical surgical excision without suturing in people with Pilonidal Cyst and Pain Postoperative, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pilonidal Cyst, Pain Postoperative, Quality of Life
- What is being tested?
- Minimally invasive pit-picking surgery and Radical surgical excision without suturing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Sep 2020to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 (men and women)
- Chronic symptomatic (primary or recurrent) pilonidal cyst
- American Society of Anesthesiologists physical status I to III
- Signed the person's information and consent form to participate in the study.
Who cannot join
- Acute pilonidal cyst
- Patients who do not speak Lithuanian
- Cognitive, visual, auditory and locomotor system disorders
- Insufficiency of kidneys, liver, cardiopulmonary system
- Refuses to participate in the study
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Lithuanian University of Health Sciences, Clinic of General Surgery
Kaunas, LT-47144
About this study
Official title: 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.
Read the 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
- Being tested
- Minimally invasive pit-picking surgery, Radical surgical excision without suturing
- Medical subject headings
- Pilonidal Sinus, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive pit-picking surgeryProcedure or 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.
Radical surgical excision without suturingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pit picking group | Experimental | Minimally invasive pilonidal cyst surgery. Receives: Procedure: Minimally invasive pit-picking surgery |
| Excision group | Experimental | Radical surgical pilonidal cyst excision without suturing Receives: Procedure: Radical surgical excision without suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week after surgery
Secondary outcomes (7)
Rate of disease recurrence
Disease recurrence will be assessed by clinical examination.
Measured: 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
Measured: One day after surgery
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Measured: Two days after surgery
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Measured: Two weeks after surgery
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Measured: One month after surgery
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Measured: Two months after surgery
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Measured: Six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Sep 2020
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pilonidal CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edvinas Dainius, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982028
- Sponsor's protocol ID
- PC1 - 4
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dainius E, Vaiciute M, Burzinskis E, Parseliunas A, Latkauskas T, Simatoniene V, Ilgunaityte S, Venskutonis D, Tamelis A. The Pilonidal Sinus Disease-Specific Quality of Life Questionnaire (SQoL): Reliability, Validity, and Utilisation. J Clin Med. 2026 Jul 27;15(15):5875. doi: 10.3390/jcm15155875.
PubMed 42589979
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients' Quality of Life and Treatment Outcomes After Pilonidal Cyst Operations.
- ClinicalTrials.gov ID
- NCT05982028
- Acronym / sponsor ID
- PC1 - 4
- Conditions
- Pilonidal Cyst, Pain Postoperative, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pit picking group | Experimental | Procedure: Minimally invasive pit-picking surgeryMinimally invasive pilonidal cyst surgery. |
| Excision group | Experimental | Procedure: Radical surgical excision without suturingRadical surgical pilonidal cyst excision without suturing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-75 (men and women)
- Chronic symptomatic (primary or recurrent) pilonidal cyst
- American Society of Anesthesiologists physical status I to III
- Signed the person's information and consent form to participate in the study.
Key exclusion criteria (5 listed)
- Acute pilonidal cyst
- Patients who do not speak Lithuanian
- Cognitive, visual, auditory and locomotor system disorders
- Insufficiency of kidneys, liver, cardiopulmonary system
- Refuses to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive pit-picking surgeryMidline 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. | Procedure or surgery | Pit picking group |
| Radical surgical excision without suturingUnder 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. | Procedure or surgery | Excision group |
Primary outcome
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.
7 secondary outcomes
Rate of disease recurrence
Time frame: Recurrence will be assessed 6 months and 2 years after surgery
Pain after surgery
Time frame: One day after surgery
Pain after surgery
Time frame: Two days after surgery
Pain after surgery
Time frame: Two weeks after surgery
Pain after surgery
Time frame: One month after surgery
Pain after surgery
Time frame: Two months after surgery
Pain after surgery
Time frame: Six months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Derived from this study: PubMed 42589979Dainius E, Vaiciute M, Burzinskis E, Parseliunas A, Latkauskas T, Simatoniene V, Ilgunaityte S, Venskutonis D, Tamelis A. The Pilonidal Sinus Disease-Specific Quality of Life Questionnaire (SQoL): Reliability, Validity, and Utilisation. J Clin Med. 2026 Jul 27;15(15):5875. doi: 10.3390/jcm15155875.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive pit-picking surgery and Radical surgical excision without suturing in people with Pilonidal Cyst and Pain Postoperative, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after surgery (time frame: One week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.