Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05430984 |
| Other study ID # |
MKSU50-6-16 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Kafrelsheikh University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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)
