- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05430984
Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair
Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair; A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kafr Al Sheikh
-
Kafr Ash Shaykh, Kafr Al Sheikh, Egypt, 33516
- Kafrelsheikh University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Laparoscopic TAPP inguinal hernia repair with mesh fixation
the mesh will be fixed to the abdominal wall using suture, spiral tacks.
|
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. |
Active Comparator: Laparoscopic TAPP inguinal hernia repair without mesh fixation
the mesh will be left as it is and the operation will be concluded
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative pain
Time Frame: 12 months
|
the degree of pain after surgery in the inguinal region assessed by numerical rating score
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MKSU50-6-16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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