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
About this trial
This is an interventional treatment trial for Inguinal Hernia
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.
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
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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