Clinical trial NCT01596049: The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair
Official title: The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair, in Comparison to the Standard Treatment in the Literature
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Primary Inguinal Hernia
Unilateral Hernia
Open Surgery
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who are undergoing Inguinal Hernia Repair Surgery.

Brief summary: This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.

The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.

The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).

Detailed description: This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.

The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.

The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).

The data will be compared to the literature and will be statistically analysed. The follow-up for each patient will be two years.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing primary unilateral open Inguinal Hernia Repair .
* patients undergoing elective surgery.
* above the age of 18 years old

Exclusion Criteria:

* patients having repeated Inguinal Hernia.
* patients having bilateral Hernia.
* patients undergoing laparoscopic surgery.
* patients undergoing non-elective surgery.

Primary outcomes:
measure: Percentage of post operative inguinal Hernia recurrence.
timeFrame: 2 weeks, 3,6,12,24 months post-operative
measure: Post-operative patient quality of life will be assessed using a validated questionnaire.
timeFrame: 2 weeks, 3,6,12,24 months post-operative
measure: Pain will be assessed by NRS (Numerical Rating Scale)
timeFrame: 2 weeks, 3,6,12,24 months post-operative
measure: Post-operative complications will be assessed using a validated questionnaire.
timeFrame: 2 weeks, 3,6,12,24 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Hifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam health care campus, Haifa, Israel
name: Adel Abu_Salih, M.D
role: PRINCIPAL_INVESTIGATOR
References: