''Lichtenstein'' tension-free mesh repair is the most common surgical techniques used for inguinal hernia repair." Read-Rives" method is tension-free, too, but here prosthesis is placed just over the peritoneum, and there is not any weak area. The aim of this study was to compare the results of "Read-Rives" and Lichtenstein method in the hernioplasty. In this prospective randomized clinical trial, 126 patients who had unilateral inguinal hernia were included. 64 patients were operated by Lichtenstein and 62 patients were operated Rives method. Early post-operative complications, duration of surgery and hospital stay, return to normal activity, and recurrence of hernia were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102085783N1
Registration date:2011-05-10, 1390/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-10, 1390/02/20
Registrant information
Name
Shaban Mehrvarz
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 3550
Email address
mehrvarz@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2002-04-04, 1381/01/15
Expected recruitment end date
2004-03-01, 1382/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of "Read-Rives" and ''Lichtenstein'' repair for treatment of unilateral inguinal hernia.
Public title
Comparison of "Read-Rives" and ''Lichtenstein'' repair for treatment of unilateral inguinal hernia.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Presence of type III and IV (Nyhus classification)
Exclusion criteria: Morbidly obese patients, presence of incarcerated or strangulated hernias
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
126
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
Baqiyatallah University of Medical Sciences
Street address
Mollasadra Ave, Vanak Square,
City
Tehran
Postal code
Approval date
2004-04-26, 1383/02/07
Ethics committee reference number
4508-22/240
Health conditions studied
1
Description of health condition studied
inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
early post-operative complications (i.e. infection, hematoma, unusual pain),
Timepoint
weekly
Method of measurement
visit and telephone
2
Description
post op pain
Timepoint
first potoprative day
Method of measurement
Visual Analog Scale(VAS)
3
Description
Return to normal activity
Timepoint
weekly
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Recurrence Rate
Timepoint
weekiy
Method of measurement
visit
Intervention groups
1
Description
Rives procedures were done through the longitudinal opening in the transversalis fascia in the inguinal floor, at the first, the prepritoneal space was dissected and the spermatic cord was parietalized, after that, a 10×15cm of mesh was implanted in front of the peritoneum, and the mesh was held in place with 2/0 nylon sutures to pubic tubercle, cooper ligament, and psoas muscle. Finally the fascia was closed over the mesh.
Category
Treatment - Surgery
2
Description
In the Lichtenstein repair for large direct hernias the sac was reduced into the prepritoneal space with purse string over it. We preferred using of a 10×15cm polypropylene (proline) mesh prosthesis for all the patients. In the Lichtenstein repair, the mesh was placed over the transversalis fascia and secured with 2/0 nylon sutures to pubic tubercle, inguinal ligament, and anterior rectus sheet.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah (a.s) hospital
Full name of responsible person
Shaban Mehrvarz
Street address
Baqiyatallah University of Medical Sciences,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences,
Full name of responsible person
Dr. Shaban Mehrvarz
Street address
Mollasadra Ave, Vanak Square,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
Dept. of Surgery, Baqiyatallah University of Medical Sciences
Full name of responsible person
Jamal Akhavan Moghaddam
Position
Assistant Professor of Surgery
Other areas of specialty/work
Street address
Mollasadra Ave, Vanak Square,
City
Tehran
Postal code
1435915371
Phone
+98 21 8803 3539
Fax
Email
dr-akhavan@yahoo.com
Web page address
www.bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences,
Full name of responsible person
Shaban Mehrvarz
Position
Associate Professor of Surgery
Other areas of specialty/work
Street address
Mollasadra Ave, Vanak Square,
City
Tehran
Postal code
1435915371
Phone
+98 21 8803 3539
Fax
Email
mehrvarz@bmsu.ac.ir
Web page address
www.bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Shaban Mehrvarz
Position
Associate Professor
Other areas of specialty/work
Street address
Mollasadra Ave, Vanak Square,
City
Tehran
Postal code
1435915371
Phone
+98 21 8126 3550
Fax
+98 21 8803 3539
Email
mehrvarz@bmsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)