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Hernia, InguinalNCT05430984

Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair

A study testing Laparoscopic TAPP inguinal hernia repair in people with Hernia, Inguinal, run by Kafrelsheikh University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hernia, Inguinal
What is being tested?
Laparoscopic TAPP inguinal hernia repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Dec 2020to 1 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients of either gender, aged between 18 and 65 years, who had early diagnosed inguinal hernia (unilateral or bilateral)

Who cannot join

  • patients with a recurrent hernia, inguinoscrotal hernia, complicated hernia (incarcerated or strangulated), known ascites or connective tissue disease, heart and kidney failure, and hypoalbuminemia

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kafrelsheikh University

    Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516

Other trials in Egypt

About this study

Official title: Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair; A Randomized Controlled Clinical Trial

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.

Read the 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)

Being tested
Laparoscopic TAPP inguinal hernia repair
Medical subject headings
Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic TAPP inguinal hernia repairProcedure or surgery

    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.

Study groups in NCT05430984
Study groupRoleWhat they receive
Laparoscopic TAPP inguinal hernia repair with mesh fixationActive comparatorthe mesh will be fixed to the abdominal wall using suture, spiral tacks.
Receives: Procedure: Laparoscopic TAPP inguinal hernia repair
Laparoscopic TAPP inguinal hernia repair without mesh fixationActive comparatorthe mesh will be left as it is and the operation will be concluded
Receives: Procedure: Laparoscopic TAPP inguinal hernia repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative pain

    the degree of pain after surgery in the inguinal region assessed by numerical rating score

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start1 Dec 2020
  3. Primary completion1 Jan 2022
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05430984
Sponsor's protocol ID
MKSU50-6-16
Status last verified
Jun 2022
First submitted
20 Jun 2022
Last updated
24 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic TAPP inguinal hernia repair in people with Hernia, Inguinal, run by Kafrelsheikh University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative pain (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.

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