Patients' Quality of Life After Pilonidal Cyst Operations.

NCT05982028 | Unknown

• 1 other identifier: PC1 - 4
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Cyst; Pain Postoperative; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  One week after surgery

Secondary Outcomes (7)

• Rate of disease recurrence

  Recurrence will be assessed 6 months and 2 years 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

Other Outcomes (5)

• Postoperative complications

  1 months after surgery

• Quality of life according to the 36-Item Short Form Survey (SF-36).

  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

  1 month after surgery

Study Arms (2)

Pit picking group

EXPERIMENTAL

Minimally invasive pilonidal cyst surgery.

Procedure: Minimally invasive pit-picking surgery

Excision group

EXPERIMENTAL

Radical surgical pilonidal cyst excision without suturing

Procedure: Radical surgical excision without suturing

Interventions

Minimally invasive pit-picking surgery 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.

Pit picking group

Radical surgical excision without suturing 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.

Excision group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences, Clinic of General Surgery

Kaunas, LT-47144, Lithuania

Location

MeSH Terms

Conditions

Pilonidal Sinus; Pain, Postoperative

Interventions

Sutures

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: August 8, 2023
• Study Start: September 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-07

Locations

LI (1)