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.
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
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)
- Conditions
- Hernia, Inguinal
- 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 group | Role | What they receive |
|---|---|---|
| Laparoscopic TAPP inguinal hernia repair with mesh fixation | Active comparator | the 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 fixation | Active comparator | the 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.
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.
- First posted24 Jun 2022
- Study start1 Dec 2020
- Primary completion1 Jan 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aouf, Kafrelsheikh University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair; A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05430984
- Acronym / sponsor ID
- MKSU50-6-16
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic TAPP inguinal hernia repair with mesh fixation | Active comparator | Procedure: Laparoscopic TAPP inguinal hernia repairthe mesh will be fixed to the abdominal wall using suture, spiral tacks. |
| Laparoscopic TAPP inguinal hernia repair without mesh fixation | Active comparator | Procedure: Laparoscopic TAPP inguinal hernia repairthe mesh will be left as it is and the operation will be concluded |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients of either gender, aged between 18 and 65 years, who had early diagnosed inguinal hernia (unilateral or bilateral)
Key exclusion criteria (1 listed)
- patients with a recurrent hernia, inguinoscrotal hernia, complicated hernia (incarcerated or strangulated), known ascites or connective tissue disease, heart and kidney failure, and hypoalbuminemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic TAPP inguinal hernia repairIsolation 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. | Procedure or surgery | Laparoscopic TAPP inguinal hernia repair with mesh fixation, Laparoscopic TAPP inguinal hernia repair without mesh fixation |
Primary outcome
postoperative pain
Time frame: 12 months
the degree of pain after surgery in the inguinal region assessed by numerical rating score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.