Pilonidal Sinus, Sinus; Dermal, Pilonidal, Umbilical Granuloma
Conditions
Keywords
Umbilical pilonidal sinus, Treatment, Surgery, Conservative, Investigational treatment, After care
Brief summary
The aim of the study was to compare the results of conservative and surgical treatment, to create an algorithm for the management of the disease, and gain more information about the etiology, pathogenesis, and course of the disease. The investigators hypothesise that surgical treatment of UPS will be better than conservative management in terms of recurrence rate, healing time, patient comfort and satisfaction, and cost effectiveness.
Detailed description
Because of its rarity, umbilical pilonidal sinus (UPS) is still poorly understood in terms of diagnosis, etiology, and the best treatment options. UPS is thought caused by hair penetrating the skin, leading to a foreign-body reaction and development of a sinus lined with granulation tissue. Most of the patients complain of pain, discharge or bleeding from the umbilicus when symptoms develop. It can be diagnosed with a careful examination, in which hairs can be seen deep in the umbilicus and usually protrude from a small sinus. Regarding the optimal treatment of the disease, a complete consensus has not yet been achieved. Some publications are recommended conservative treatment, while surgical treatment is recommended in others. A more meaningful comparison of the two modalities is that of a randomized controlled trial. We, therefore, present our data of prospective randomized controlled clinical trial comparing conservative versus surgical treatment of UPS. This was a multicenter, prospective balanced randomization, double blind, active-controlled, parallel-group, superiority study conducted in Turkey, under the direction of a principal investigator (MK). Eligible patients with UPS were randomized for either conservative treatment (CT) or surgical treatment (ST), and then the results of both groups were compared.
Interventions
PROCEDURESurgery
modified umbilectomy
OTHERconservative
this treatment will include conservative procedures under local anesthesia for patient comfort.
Sponsors
Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
Medical Park Gaziantep Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* all patients willing to participate to the study with the diagnosis of umbilical pilonidal sinus
Exclusion criteria
* no informed consent * serious coagulation abnormalities * known allergy to local anesthetics * pregnancy, or women who refused contraception at the time of treatment * other concomitant umbilical pathologies such as umbilical hernia, granuloma, dermoid cyst * the patients who diagnosed with urachal and omphalomesenteric anomalies through radiological investigation * patients who underwent umbilical operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure Rate | 2 year after initial treatment | Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure. Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing Time | two year | the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms. |
| Visual Analogue Scale for Patient Satisfaction (VAS-PS) | 30 days | Well-being and satisfaction scales comprised linear metric scales known as visual analogue scales, with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Costs | two year | from initial treatment to the complete healing, all kind of cost will be calculated. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conservative Conservative treatment described as follow:
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry. | 42 |
| Surgery Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination. | 42 |
| Total | 84 |
Baseline characteristics
| Characteristic | Conservative | Surgery | Total |
|---|---|---|---|
| Age, Continuous | 21.80 years | 19.86 years | 20.83 years |
| Gender Female | 3 Participants | 2 Participants | 5 Participants |
| Gender Male | 39 Participants | 40 Participants | 79 Participants |
| Region of Enrollment Turkey | 42 participants | 42 participants | 84 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Cure Rate
Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure. Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy.
Time frame: 2 year after initial treatment
Population: Of the 84 patients 41 patients in the CT group. and 40 patients in ST group were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conservative | Cure Rate | 28 participants |
| Surgery | Cure Rate | 40 participants |
Secondary
Healing Time
the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms.
Time frame: two year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conservative | Healing Time | 12.81 days | Standard Deviation 2.96 |
| Surgery | Healing Time | 17.06 days | Standard Deviation 5.1 |
Secondary
Visual Analogue Scale for Patient Satisfaction (VAS-PS)
Well-being and satisfaction scales comprised linear metric scales known as visual analogue scales, with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment).
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conservative | Visual Analogue Scale for Patient Satisfaction (VAS-PS) | 66 units on a scale | Standard Deviation 8 |
| Surgery | Visual Analogue Scale for Patient Satisfaction (VAS-PS) | 71 units on a scale | Standard Deviation 6 |
Other Pre-specified
Costs
from initial treatment to the complete healing, all kind of cost will be calculated.
Time frame: two year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conservative | Costs | 609 USD dollars | Standard Deviation 224 |
| Surgery | Costs | 479 USD dollars | Standard Deviation 75 |