Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair
Primary Purpose
Hernia, Inguinal
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic TAPP inguinal hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Inguinal
Eligibility Criteria
Inclusion Criteria:
- Adult patients of either gender, aged between 18 and 65 years, who had early diagnosed inguinal hernia (unilateral or bilateral)
Exclusion Criteria:
- patients with a recurrent hernia, inguinoscrotal hernia, complicated hernia (incarcerated or strangulated), known ascites or connective tissue disease, heart and kidney failure, and hypoalbuminemia
Sites / Locations
- Kafrelsheikh University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Laparoscopic TAPP inguinal hernia repair with mesh fixation
Laparoscopic TAPP inguinal hernia repair without mesh fixation
Arm Description
the mesh will be fixed to the abdominal wall using suture, spiral tacks.
the mesh will be left as it is and the operation will be concluded
Outcomes
Primary Outcome Measures
postoperative pain
the degree of pain after surgery in the inguinal region assessed by numerical rating score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05430984
Brief Title
Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair
Official Title
Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair; A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This work aims to study the outcomes of mesh fixation versus non-fixation of laparoscopic TAPP inguinal hernia repair as regards postoperative pain, recurrence, operative time, and other postoperative complications.
Detailed Description
This is a randomized controlled clinical trial that will be conducted on patients who will undergo laparoscopic TAPP inguinal hernia repair in the General Surgery Department. Adult patients of either gender, aged between 18 and 65 years, who had early diagnosed inguinal hernia (unilateral or bilateral) were included. We excluded patients with a recurrent hernia, inguinoscrotal hernia, complicated hernia (incarcerated or strangulated), known ascites or connective tissue disease, heart and kidney failure, and hypoalbuminemia.
Surgery will be performed under general anaesthesia with endotracheal intubation. Patients will be placed in the Trendelenburg position with access to the abdominal cavity through the umbilical port; then, pneumoperitoneum is obtained at 15 mmHg. After pneumoperitoneum, a laparoscope will be inserted through the umbilical incision. The second and third holes will be made on the abdominal median line's left and right side at the umbilical level.
When entering the abdominal cavity, the peritoneum will be cut open in a curved shape 3 cm to the superior margin of the defect. To avoid urinary bladder injury, the medial border of the incision won't cross the medial umbilical ligament. Special attention will be paid to avoid inferior epigastric artery injury while cutting open the peritoneum in the medial part.
When the sac of the oblique hernia enters the internal ring, it will be isolated as much as possible. If there is a large lipoma outside the hernia sac will also be excised. Isolation of preperitoneal space will be accomplished to guarantee the mesh flattening with the medial border at the pubic symphysis, the lateral border at the psoas major and anterior superior iliac spine, superior border at least 3 cm above the conjoined tendon, medial inferior border 3 cm below the pectineal ligament, and lateral inferior border to permit perietalization of the spermatic cord (6-8 cm isolation of the hernia sac and spermatic cord). The patient is tilted head-down position.
For the mesh fixation group, the mesh will be fixed to the abdominal wall using suture, spiral tacks, whereas for the non-fixation group it will be left as it is and the operation will be concluded. A mesh measuring 15x10cm is placed in the preperitoneal space and fixed using limited numbers of tacks or suture. In some cases, based on body habitus, a slightly smaller mesh could be used. The peritoneum will be closed over the mesh to reduce the risk of mesh adhesion to intestines, erosion, fistula formation, and small bowel obstruction by one of three methods: suture, or tack closure.
Operative data will be collected as regard operative time, the effect on chronic pain and quality of life, recurrence, and other complications (seroma, urine retention)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic TAPP inguinal hernia repair with mesh fixation
Arm Type
Active Comparator
Arm Description
the mesh will be fixed to the abdominal wall using suture, spiral tacks.
Arm Title
Laparoscopic TAPP inguinal hernia repair without mesh fixation
Arm Type
Active Comparator
Arm Description
the mesh will be left as it is and the operation will be concluded
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic TAPP inguinal hernia repair
Intervention Description
Isolation of preperitoneal space will be accomplished to guarantee the mesh flattening with the medial border at the pubic symphysis, the lateral border at the psoas major and anterior superior iliac spine, superior border at least 3 cm above the conjoined tendon, medial inferior border 3 cm below the pectineal ligament, and lateral inferior border to permit perietalization of the spermatic cord (6-8 cm isolation of the hernia sac and spermatic cord).
For the mesh fixation group, the mesh will be fixed to the abdominal wall using suture, spiral tacks, whereas for the non-fixation group it will be left as it is and the operation will be concluded. A mesh measuring 15x10cm is placed in the preperitoneal space and fixed using limited numbers of tacks or suture. In some cases, based on body habitus, a slightly smaller mesh could be used. The peritoneum will be closed over the mesh.
Primary Outcome Measure Information:
Title
postoperative pain
Description
the degree of pain after surgery in the inguinal region assessed by numerical rating score
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients of either gender, aged between 18 and 65 years, who had early diagnosed inguinal hernia (unilateral or bilateral)
Exclusion Criteria:
patients with a recurrent hernia, inguinoscrotal hernia, complicated hernia (incarcerated or strangulated), known ascites or connective tissue disease, heart and kidney failure, and hypoalbuminemia
Facility Information:
Facility Name
Kafrelsheikh University
City
Kafr Ash Shaykh
State/Province
Kafr Al Sheikh
ZIP/Postal Code
33516
Country
Egypt
12. IPD Sharing Statement
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Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair
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