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

Inguinal Hernia Clinical Trial

— professor  

Official title:

Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal (TAPP) Inguinal Hernia Repair Without Mesh Fixation, Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532983
• Other study ID #: hazem tapp no fix
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• fixation of mesh prosthesis
in the first group mesh was fixed in position with laparoscopic tacks
• mesh placement without fixation
mesh placement in preperitoneal space without fixation

Locations

Country	Name	City	State
Egypt	Zagazig Faculty of Medicine	Zagazig	Sharqya

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	pain in the first 6 month of surgery measured by visual analogue scale	6 month
Primary	hernia recurrence	recurrence of inguinal hernia measured by computed tomography of the abdomen	1 year