Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal Inguinal Hernia Repair Without Mesh Fixation (professor)

Z

Zagazig University

Status

Completed

Conditions

Inguinal Hernia

Treatments

Procedure: mesh placement without fixation
Procedure: fixation of mesh prosthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT04532983
hazem tapp no fix

Details and patient eligibility

About

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

Full 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

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups

fixation group
Active Comparator group
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),
Treatment:
Procedure: fixation of mesh prosthesis
non fixation group
Active Comparator group
Description:
group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
Treatment:
Procedure: mesh placement without fixation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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