Comparison of Cure and Relapse Rate of the Symptoms in Umbilical Pilonidal Sinus in two surgical way complete sinus excision with reconstruction of umbilicus and sinus excision with umbilical preservation
60 patients with umbilical pilonidal sinus who had not undergone any previous surgeries are operated on using two techniques that group1(30 patients) involves complete excision of the sinus after eversion of the umbilicus are followe by reconstruction of the umbilicus. in group2(30 patients) Under general anesthesia, reveale a 3-mm ulcerated site in the depth of the umbilicus from which bits of hair protruded. A vertical skin incision through the umbilicus skirting one side of the sinuses was made. Diathermy cutting use to minimize bleeding and ensure visibility of the lesion.the tract were completely excised. The skin close primarily and patients in two groups give 3 course of antibiotics. Patients then followe and wound complications, recurrence, and patient satisfaction evaluate at 1 week,2 week,1 month,3 month,6 month postoperative visits.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011912172N1
Registration date:2013-03-08, 1391/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-08, 1391/12/18
Registrant information
Name
Mahdieh Amirbeigy
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
amirbeigy@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Cure and Relapse Rate of the Symptoms in Umbilical Pilonidal Sinus in two surgical way complete sinus excision with reconstruction of umbilicus and sinus excision with umbilical preservation
Public title
Comparison of Cure and Relapse Rate of the Symptoms in Umbilical Pilonidal Sinus in two surgical way complete sinus excision with reconstruction of umbilicus and sinus excision with umbilical preservation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:purulent or bloody discharge and itching from the umbilicus;bits of hair or granulation tissue in the depths of the umbilicus.
Exclusion criteria:fever;intra-abdominal symptoms; epidermal cysts;endometriosis;omphalomesenteric duct remnants;urachal anomalies;benign or malignant tumor;history of laparotomy; previous abdominal surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences and Health Services
Street address
Medical college, Ghotb Ravandi boulevard
City
Kashan
Postal code
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
2880/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Pilonidal cyst
ICD-10 code
L05.9
ICD-10 code description
Pilonidal cyst without abscess
Primary outcomes
1
Description
Cure of umbilical pilonidal sinus
Timepoint
one week two weeks one month three months six months
Method of measurement
observation , questionnaire
Secondary outcomes
1
Description
relapse of umbilical pilonidal sinus
Timepoint
one week two weeks one month three months six months
Method of measurement
obsevation, questionnaire
Intervention groups
1
Description
complete sinus excision with reconstruction of umbilicus
Category
Treatment - Surgery
2
Description
pilonidal sinus excision with umbilical preservation