Neoplasms

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Immune System Diseases

Pilonidal Sinus

Granuloma

Paranasal Sinus Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Cysts

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Anesthetics

Ornidazole

Anti-Bacterial Agents

Ampicillin

Antibiotics, Antitubercular

Sulbactam

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.

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.

Surgery

this treatment will include conservative procedures under local anesthesia for patient comfort.

conservative

Mehmet KAPLAN, MD

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.

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.

Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial

from initial treatment to the complete healing, all kind of cost will be calculated.

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.

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.

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).

Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.

Medical Park Gaziantep Hospital

Principal investigator

Conservative treatment described as follow:

Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.

Conservative

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.

Total

Age, Continuous

Gender

Turkey

Region of Enrollment

Dr. Mehmet Kaplan

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.

conservative: this treatment will include conservative procedures under local anesthesia for patient comfort.

Of the 84 patients 41 patients in the CT group. and 40 patients in ST group were analyzed

Cure Rate

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.

Surgery: modified umbilectomy

Healing Time

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.

Visual Analogue Scale for Patient Satisfaction (VAS-PS)

Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease	NCT01662765	Pilonidal Sinus Sinus; Dermal, ... Umbilical Granu...	Surgery conservative	-	Medical Park Gaziantep Hospital
Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease	NCT01662765	Pilonidal Sinus Sinus; Dermal, ... Umbilical Granu...	Surgery conservative	-	Medical Park Gaziantep Hospital

Spots Global Cancer Trial Database for umbilical granuloma