An interventional study of Minimally invasive pit-picking surgery and Radical surgical excision without suturing in Pilonidal Cyst, Pain Postoperative and Quality of Life, sponsored by Lithuanian University of Health Sciences. Enrolling by invitation at 1 site in Lithuania. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by Lithuanian University of Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Lithuanian University of Health Sciences is the lead sponsor of 105 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Minimally invasive pilonidal cyst surgery.
Procedure: Minimally invasive pit-picking surgery
Radical surgical pilonidal cyst excision without suturing
Procedure: Radical surgical excision without suturing
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.
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.
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.
Time frame: One week after surgery
Rate of disease recurrence
Disease recurrence will be assessed by clinical examination.
Time frame: 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
Time frame: One day after surgery
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time frame: Two days after surgery
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time frame: Two weeks after surgery
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time frame: One month after surgery
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time frame: Two months after surgery
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time frame: Six months after surgery
Postoperative complications
Patients will report past complications.
Time frame: 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.
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.
Duration of disability
Patients will note the duration of incapacity for work.
Time frame: 1 month after surgery
Wound healing time
Patients will note the time when the wound healed.
Time frame: 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.
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.
Started Sep 2020 (actual). Primary completion is estimated for Sep 2024, 48 months after the start.
Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 48 months is above that.
How these figures are worked out, and which studies are left out of them.
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