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

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fixation of mesh prosthesis
mesh placement without fixation
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Zagazig Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

fixation group

non fixation group

Arm 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),

group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.

Outcomes

Primary Outcome Measures

postoperative pain
pain in the first 6 month of surgery measured by visual analogue scale
hernia recurrence
recurrence of inguinal hernia measured by computed tomography of the abdomen

Secondary Outcome Measures

Full Information

First Posted
August 26, 2020
Last Updated
August 26, 2020
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04532983
Brief Title
Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal Inguinal Hernia Repair Without Mesh Fixation
Acronym
professor
Official Title
Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal (TAPP) Inguinal Hernia Repair Without Mesh Fixation, Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
the participants and the follow up surgeon don't know which received fixation
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fixation group
Arm Type
Active Comparator
Arm 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),
Arm Title
non fixation group
Arm Type
Active Comparator
Arm Description
group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
Intervention Type
Procedure
Intervention Name(s)
fixation of mesh prosthesis
Intervention Description
in the first group mesh was fixed in position with laparoscopic tacks
Intervention Type
Procedure
Intervention Name(s)
mesh placement without fixation
Intervention Description
mesh placement in preperitoneal space without fixation
Primary Outcome Measure Information:
Title
postoperative pain
Description
pain in the first 6 month of surgery measured by visual analogue scale
Time Frame
6 month
Title
hernia recurrence
Description
recurrence of inguinal hernia measured by computed tomography of the abdomen
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hazem nour
Organizational Affiliation
zag university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig Faculty of Medicine
City
Zagazig
State/Province
Sharqya
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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