Assessing the effect of closed suction drainage by using of prosthesis (Lichtenstein technique) in preventing wound complications following inguinal hernioplasty in Amir-Al-Momenin hospital, Semnan, 2013
Aims
There are several methods to prevent or to drain seroma. We aimed to assess effects of closed suction drainage system insertion in preventing of wound complications..
Design of the study:
In a clinical trial, 42 patients with primary inguinal hernia candidate for hernioplasty by using of prosthetic who underwent surgery to repair for first time were enrolled and randomly divided into two groups.
The main inclusion and exclusion criteria:
Inclusion criteria: Patients with primary inguinal hernia, having good condition for surgery under general anesthesia. Exclusion criteria: Recurrent hernia.
Sample size: 42 patients with primary inguinal hernia who divided into two groups.
Interventions:
21 patients underwent hernia surgery without drains and 21 others with closed suction drainage system. In the first group after hernia repair with prosthesis (Liechtenstein technique) do not used any drains, and in other group closed suction drainage was established. Patients were evaluated 24 hours after surgery in the hospital, and 4-7 days and 10-15 days after surgery in clinic for complications including the formation of seroma, hematoma and wound infection or other complications.
Time of intervention: In the end of surgery in operating room.
Study outcomes: Decreasing of wound complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120118168N2
Registration date:2014-12-19, 1393/09/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Hamid Reza Hemmati
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7822
Email address
dr.hahemmati@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of closed suction drainage by using of prosthesis (Lichtenstein technique) in preventing wound complications following inguinal hernioplasty in Amir-Al-Momenin hospital, Semnan, 2013
Public title
Assessing the effect of closed suction drainage in preventing wound complications following inguinal hernioplasty by using of prosthesis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with primary inguinal hernia, Having good condition for surgery under general anesthesia.
Exclusion criteria: Recurrent hernia.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee, Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Postal code
Approval date
2014-03-08, 1392/12/17
Ethics committee reference number
93/564791 Date:16/12/1392
Health conditions studied
1
Description of health condition studied
Surgical Wound Complications
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure, not elsewhere classified
Primary outcomes
1
Description
Surgical Wound Complications
Timepoint
24 Hours, 4-7 days and 10-15 days after surgery
Method of measurement
Examination, Inspection and drainage culture
Secondary outcomes
1
Description
Fever and tenderness around the surgical wound
Timepoint
24 hours, 4-7 and 10-15 days after surgery
Method of measurement
Examination and Inspection
Intervention groups
1
Description
21 patients as control group were undergoing hernia surgery that repair with prosthesis (Liechtenstein technique) without insertinf of drains.
Category
Treatment - Surgery
2
Description
21 patients as intervention group underwent hernia surgery with prosthesis (Liechtenstein technique) and closed suction drainage system was established after at the incision
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Al-Mimenin Hospital
Full name of responsible person
Dr. Hamidreza Hemmati
Street address
Imam Hussein square
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Basidj Boulevard
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Hemmati
Position
Torasic Surgeon/ Assistant Professor
Other areas of specialty/work
Street address
Imam Hussein square
City
Semnan
Postal code
Phone
+98 23 3343 7822
Fax
Email
dr.hahemmati@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of medical Sciences
Full name of responsible person
Dr Hamidreza Hemmati
Position
Torax Surgeon/ Assistant Professor
Other areas of specialty/work
Street address
Imam Hussein Square
City
Semnan
Postal code
Phone
+98 23 3343 7822
Fax
Email
dr.hhemmati@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Nurse BSN, Resarch Expert
Other areas of specialty/work
Street address
Basidj Boulevard, Amin Ave., Kowsar Hospital
City
Semnan
Postal code
Phone
+98 23 3343 7822
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)