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Patients' Quality of Life After Pilonidal Cyst Operations.

Primary Purpose

Pilonidal Cyst, Pain Postoperative, Quality of Life

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Minimally invasive pit-picking surgery
Radical surgical excision without suturing
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Cyst

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Lithuanian University of Health Sciences, Clinic of General Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pit picking group

Excision group

Arm Description

Minimally invasive pilonidal cyst surgery.

Radical surgical pilonidal cyst excision without suturing

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of disease recurrence
Disease recurrence will be assessed by clinical examination.
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Pain after surgery
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain

Full Information

First Posted
July 15, 2023
Last Updated
July 30, 2023
Sponsor
Lithuanian University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05982028
Brief Title
Patients' Quality of Life After Pilonidal Cyst Operations.
Official Title
Evaluation of Patients' Quality of Life and Treatment Outcomes After Pilonidal Cyst Operations.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Cyst, Pain Postoperative, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pit picking group
Arm Type
Experimental
Arm Description
Minimally invasive pilonidal cyst surgery.
Arm Title
Excision group
Arm Type
Experimental
Arm Description
Radical surgical pilonidal cyst excision without suturing
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive pit-picking surgery
Intervention Description
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
Intervention Name(s)
Radical surgical excision without suturing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain after surgery
Description
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
Secondary Outcome Measure Information:
Title
Rate of disease recurrence
Description
Disease recurrence will be assessed by clinical examination.
Time Frame
Recurrence will be assessed 6 months and 2 years after surgery
Title
Pain after surgery
Description
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time Frame
One day after surgery
Title
Pain after surgery
Description
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time Frame
Two days after surgery
Title
Pain after surgery
Description
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time Frame
Two weeks after surgery
Title
Pain after surgery
Description
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time Frame
One month after surgery
Title
Pain after surgery
Description
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time Frame
Two months after surgery
Title
Pain after surgery
Description
Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
Time Frame
Six months after surgery
Other Pre-specified Outcome Measures:
Title
Postoperative complications
Description
Patients will report past complications.
Time Frame
1 months after surgery
Title
Quality of life according to the 36-Item Short Form Survey (SF-36).
Description
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.
Title
Duration of disability
Description
Patients will note the duration of incapacity for work.
Time Frame
1 month after surgery
Title
Wound healing time
Description
Patients will note the time when the wound healed.
Time Frame
Six months after surgery
Title
Quality of life total scores according to a specific life questionnaire developed by the researcher.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Lithuanian University of Health Sciences, Clinic of General Surgery
City
Kaunas
ZIP/Postal Code
LT-47144
Country
Lithuania

12. IPD Sharing Statement

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Patients' Quality of Life After Pilonidal Cyst Operations.

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