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Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

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ClinicalTrials.gov Identifier: NCT01662765
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Collaborator:
Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
Information provided by (Responsible Party):
Mehmet Kaplan, Medical Park Gaziantep Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pilonidal Sinus
Sinus; Dermal, Pilonidal
Umbilical Granuloma
Interventions Procedure: Surgery
Other: conservative
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Conservative Surgery
Hide Arm/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.

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

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.

Period Title: Overall Study
Started 42 42
Completed 41 40
Not Completed 1 2
Arm/Group Title Conservative Surgery Total
Hide Arm/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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 42 42 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 84 participants
21.80
(12 to 34)
19.86
(10 to 37)
20.83
(10 to 37)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Female
3
   7.1%
2
   4.8%
5
   6.0%
Male
39
  92.9%
40
  95.2%
79
  94.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Turkey Number Analyzed 42 participants 42 participants 84 participants
42 42 84
1.Primary Outcome
Title Cure Rate
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 84 patients 41 patients in the CT group. and 40 patients in ST group were analyzed
Arm/Group Title Conservative Surgery
Hide Arm/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.

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

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.

Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: participants
28 40
2.Secondary Outcome
Title Healing Time
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgery Conservative
Hide Arm/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.

Surgery: modified umbilectomy

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.

Overall Number of Participants Analyzed 42 42
Mean (Standard Deviation)
Unit of Measure: days
12.81  (2.96) 17.06  (5.1)
3.Secondary Outcome
Title Visual Analogue Scale for Patient Satisfaction (VAS-PS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conservative Surgery
Hide Arm/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.

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.
Overall Number of Participants Analyzed 33 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
66  (8) 71  (6)
4.Other Pre-specified Outcome
Title Costs
Hide Description from initial treatment to the complete healing, all kind of cost will be calculated.
Time Frame two year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conservative Surgery
Hide Arm/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.

Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
Overall Number of Participants Analyzed 42 42
Mean (Standard Deviation)
Unit of Measure: USD dollars
609  (224) 479  (75)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conservative Surgery
Hide Arm/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.

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.

All-Cause Mortality
Conservative Surgery
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Conservative Surgery
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Conservative Surgery
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/42 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mehmet Kaplan
Organization: Bahcesehir University, School of Medicine
Phone: +905056268899
EMail: dr.kaplan27@gmail.com
Layout table for additonal information
Responsible Party: Mehmet Kaplan, Medical Park Gaziantep Hospital
ClinicalTrials.gov Identifier: NCT01662765     History of Changes
Other Study ID Numbers: MK-003-UPS
First Submitted: August 8, 2012
First Posted: August 10, 2012
Results First Submitted: January 18, 2016
Results First Posted: February 16, 2017
Last Update Posted: February 16, 2017