Skip to main content
Clinical Trials/NCT05982028
NCT05982028Enrolling By InvitationNot Applicable

Evaluation of Patients' Quality of Life and Treatment Outcomes After Pilonidal Cyst Operations.

Lithuanian University of Health Sciences1 site in 1 country100 target enrollmentStarted: September 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
100
Locations
1
Primary Endpoint
Pain after surgery

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Pit picking group

Experimental

Minimally invasive pilonidal cyst surgery.

Intervention: Minimally invasive pit-picking surgery (Procedure)

Excision group

Experimental

Radical surgical pilonidal cyst excision without suturing

Intervention: Radical surgical excision without suturing (Procedure)

Outcomes

Primary Outcomes

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 Outcomes

  • Rate of disease recurrence(Recurrence will be assessed 6 months and 2 years after surgery)
  • Pain after surgery(Six months after surgery)
  • Pain after surgery(One day after surgery)
  • Pain after surgery(Two days after surgery)
  • Pain after surgery(Two weeks after surgery)
  • Pain after surgery(One month after surgery)
  • Pain after surgery(Two months after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Edvinas Dainius

Principal Investigator

Lithuanian University of Health Sciences

Study Sites (1)

Loading locations...

Similar Trials