Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial
Surgery
+ conservative
Cysts+3
+ Neoplasms
+ Pathological Conditions, Signs and Symptoms
Treatment Study
Summary
Study start date: November 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.84 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Medical Park Gaziantep Hospital
Gaziantep, Turkey (Türkiye)25 Aralık Familiy Physician Health Center
Gaziantep, Turkey (Türkiye)Dr.Ersin Arslan State Hospital
Gaziantep, Turkey (Türkiye)