Clinical trial NCT04532983: Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal Inguinal Hernia Repair Without Mesh Fixation
Official title: Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal (TAPP) Inguinal Hernia Repair Without Mesh Fixation, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-08-31
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
Primary purpose: TREATMENT

Brief summary: comparison between two groups of participants suffering inguinal hernia each group 23 individual all underwent laparoscopic trans-abdominal inguinal hernia repair first group received mesh fixation the second underwent no fixation , results of follow up in the first year were compared together

Detailed description: This comparative study was performed in Zagazig university hospitals, general surgery department in the time period between july 2018 and june 2020 0n 46 patients undergoing laparoscopic trans abdominal preperitoneal (TAPP) repair for un complicated unilateral inguinal hernia.

Patient selection; In this study we enrolled patients above

* 18 years old suffering unilateral,
* non -recurrent,
* un-complicated inguinal hernia. We excluded patients with
* previous abdominal or pelvic surgery,
* unfit with laparoscopic surgery,
* those with ascites,
* abdominal malignancy
* on chemotherapy and immune-compromised patients.

Randomization; using computer generated random numbers , the study participants were randomly allocated into two equal groups each group 23 individual, the first group; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.

All the study participants were subjected to thorough history taking, detailed clinical examination, determination of the presence of inguinal hernia, measurement of the hernia defect diameter by ultrasound or computerized tomography in difficult cases, preoperative laboratory tests were performed as per usual

Follow up Early postoperative data during the admission were collected, a; pain score (measured by visual analogue scale (VAS), hematoma formation, early recurrence, time needed for ambulation.

Follow up was carried out in outpatients clinics by the attending surgeon after 1 week, 1 month,3 months and 6 months of the operation , the recorded follow up data included wound complications, seroma formation, foreign body sensation and recurrence.

The study was approved by the local ethical committee and institutional review board (IRB) of our university hospitals, all patients signed an informed written consent before participation in this study Preoperative, demographic, operative and postoperative data were collected and properly analyzed using t test, Z test in SPSS 22 program package

Eligibility criteria: Inclusion Criteria:

* 18 years old suffering unilateral,
* non -recurrent,
* un-complicated inguinal hernia.

Exclusion Criteria:

* previous abdominal or pelvic surgery,
* unfit with laparoscopic surgery,
* those with ascites,
* abdominal malignancy
* on chemotherapy and immune-compromised patients.

Primary outcomes:
measure: postoperative pain
timeFrame: 6 month
measure: hernia recurrence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig Faculty of Medicine
state: Sharqya
Study officials:
affiliation: zag university
name: hazem nour
role: PRINCIPAL_INVESTIGATOR
References: