Clinical trial NCT01237470: The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.
Official title: The Desarda and Lichtenstein Techniques in Primary Hernia Treatment in Adult Males: Randomised, Multicenter, Blinded Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hernia, Inguinal
Keywords: inguinal hernia
hernia recurrence
no mesh techniques
Desarda technique
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 2009
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. The implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the initial implantation site, increase costs of treatment etc. The research to find any new hernioplasty without the use of meshes is still going on.

Desarda in 2002 year published his own results over hernia treatment with the use of external oblique aponeurosis. These results were comparable with the effects of Lichtenstein technique.

The initial assessment done in our own department revealed good clinical results after hernia treatment with Desarda's method.

To make appropriate and objective clinical assessment of the Desarda's technique for primary inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.

Generally no statistically significant differences were found between these groups. The only difference was higher rate of seroma after Lichtenstein technique and different pain perception in both groups. To the summary it is clear that Desarda technique is quite attractive and good proposition for operative hernia treatment without mesh. The RCT was done with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for clinical trials.


Eligibility criteria: Inclusion Criteria:

* primary inguinal hernia
* male adults
* signed informed consent
* god condition of external oblique aponeurosis (assessed during the operation)

Exclusion Criteria:

* age \< 18
* recurrent hernia
* incarcerated hernia
* diagnosed mental disorder
* manual reduction of hernia on inpatient
* infection at groin area
* wound or scar at the groin
* no consent

Primary outcomes:
measure: recurrence
timeFrame: 3 years
measure: chronic pain
timeFrame: 6 months
Secondary outcomes:
measure: surgical complications
timeFrame: 3 years
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University
Study officials:
affiliation: Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz, Poland
name: Stanislaw Dabrowiecki, MD, PhD
role: STUDY_CHAIR
References:
citation: Desarda MP. Inguinal herniorrhaphy with an undetached strip of external oblique aponeurosis: a new approach used in 400 patients. Eur J Surg. 2001 Jun;167(6):443-8. doi: 10.1080/110241501750243798.
citation: Desarda MP. Surgical physiology of inguinal hernia repair--a study of 200 cases. BMC Surg. 2003 Apr 16;3:2. doi: 10.1186/1471-2482-3-2.