Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

Medical Park Gaziantep Hospital

Status: Completed

Conditions: Umbilical Granuloma; Sinus; Dermal, Pilonidal; Pilonidal Sinus

Treatments: Other: conservative; Procedure: Surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01662765

MK-003-UPS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups

Surgery

Experimental group

Description:

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.

Treatment:

Procedure: Surgery

Conservative

Active Comparator group

Description:

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.

Treatment:

Other: conservative