Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pilonidal Sinus Sinus; Dermal, Pilonidal Umbilical Granuloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Surgery

Intervention Type PROCEDURE

modified umbilectomy

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.

Group Type ACTIVE_COMPARATOR

conservative

Intervention Type OTHER

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

Interventions

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Surgery

modified umbilectomy

Intervention Type PROCEDURE

conservative

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

Intervention Type OTHER

Other Intervention Names

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umbilectomy non-surgical management

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No