Congenital Inguinal HerniaNCT06660550
Needlescopic Versus Traditional Laparoscopic Inguinal Hernia Repair in Pediatrics
A study testing laparoscopic inguinal hernia repair and Needlescopic inguinal hernia repair in people with Congenital Inguinal Hernia, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the results of Needlescopic inguinal hernia repair in comparison with traditional laparoscopic repair in children as regard operative time, cosmetic appearance, recurrence and other complications. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Inguinal Hernia
- What is being tested?
- laparoscopic inguinal hernia repair and Needlescopic inguinal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Include patients presented with inguinal hernia with age < 18 years.
Who cannot join
- Age above 18 years.
- Complicated inguinal hernia (e.g. irreducibility, obstruction and strangulation).
- Pervious lower abdominal surgeries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed M Abd El-Moniem, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospitals
Sohag
Abdelaziz A Abdelaziz, Resident, 00201010274505, abdelazeez.ali@med.sohag.edu.eg
Ahmed M Abd El-Moniem, Professor, 00201005768450
About this study
Official title: Needlescopic Versus Traditional Laparoscopic Inguinal Hernia Repair in Pediatrics (A Prospective Comparative Study)
The aim of the study is to evaluate the results of Needlescopic inguinal hernia repair in comparison with traditional laparoscopic repair in children as regard operative time, cosmetic appearance, recurrence and other complications.
Read the detailed description
Patients and methods:
- Place of the study: The study will be held in Department of Pediatric surgery in Sohag University Hospital.
- Type of the study: Prospective comparative Cohort study.
- Duration of the study: The study will last for 6 to 9 months starting from the date of acceptance of the protocol.
- Ethical considerations: The study will be carried out after approval by scientific and ethical committees of Sohag faculty of medicine.
- Method of the study:
Preoperative assessment:
- Demographic data: e.g. name, age, sex …. etc.
- History: e.g. complaint, present history and past surgical and medical history…etc.
- General and local examination: e.g. laterality, associated anomalies …. etc.
- Investigations:
Routine labs. Imaging: to confirm diagnosis in the affected side, to evaluate contralateral side, bilateral testicular volume as volumetric stander to evaluate testicular atrophy postoperative and other anomalies.
Operative technique:
Operative steps:
- Traditional laparoscopic repair.
- STEPS:
- A 5mm port for the camera is introduced at umbilicus by open technique.
- Using triangulation rule to introduce two working ports.
- The abdomen is insufflated with carbon dioxide to 6-8 mmHg pressure in patients under 1 year of age and to 8-10 mmHg in older children.
- Diathermize the neck of the hernia sac with a diathermy hook.
- A 10-15 cm absorbable suture is passed into the peritoneal cavity through the abdominal wall next to the lateral port under vision.
- The purse-string stitch commences at the 2 o'clock position of the internal hernia opening.
- ensure that a "complete ring" of peritoneum has been included in the purse-string stitch without significant gaps.
- The purse-string suture is tied tightly using intracorporeally knot tying.
- Needlescopic Internal Ring Suturing.
- EQUIPMENT/SUTURE:
- One 5-mm trocar and 5-mm lens 30° or 0° telescope.
- Epidural needle.
- Non absorbable suture.
- Fascial closure instrument.
- STEPS:
- A 5mm port for the camera is introduced at umbilicus by open technique.
- The abdomen is insufflated with carbon dioxide to 6-8 mmHg pressure in patients under 1 year of age and to 8-10 mmHg in older children.
- The suture is introduced through the barrel of the epidural needle.
- Maintaining both ends of the preloaded suture extra peritoneal, the needle is advanced under the peritoneum around lateral half of the internal ring.
- The peritoneum is entered and the suture advanced into the abdominal cavity, creating a loop.
- Fascial closure instrument is introduced directly through anterior abdominal wall to help to maintain suture loop.
- The needle is removed, leaving the loop in place.
- The needle is entered again through the same skin puncture site around the medial half of the ring and enter the peritoneum, leaving a small space above the vas deferens and testicular vessels to avoid injury.
- The loop of suture is introduced into the hollow of the needle again and advance the suture into the first loop by the help of fascial closure.
- Withdraw the needle.
- Catch the suture end in the loop and withdraw them together then the suture is tied extra corporeally.
Patient outcomes:
Patients assessment and follow up:
- Primary outcome measures: Operative time. Intraoperative complication. Rate of conversion to open surgery.
- Secondary outcome measures:
1 and 3 months after the surgery to asses:
- Cosmetic appearance: according to (The Scar Cosmesis Assessment and Rating "SCAR" Scale) [7].
- Recurrence.
- Hydrocele.
- Testicular atrophy (postoperative imaging: > 50% loss of testicular volume or < 25% of volume of contralateral testis) [8].
- Conditions
- Congenital Inguinal Hernia
- Being tested
- laparoscopic inguinal hernia repair, Needlescopic inguinal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic inguinal hernia repairProcedure or surgery
traditional laparoscopic repair
Needlescopic inguinal hernia repairProcedure or surgery
Needlescopic inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Needlescopic inguinal hernia repair | Active comparator | Not described Receives: Procedure: Needlescopic inguinal hernia repair |
| Traditional laparoscopic inguinal hernia repair | Active comparator | Not described Receives: Procedure: laparoscopic inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time from start of incision making till end of operation and closure of incisions
Measured: during operation
Intraoperative complications
as injury to inferior epigastric vessels, vas deferens and major pelvic vessels
Measured: during operation
Rate of conversion to open surgery.
rate of conversion from laparoscopic surgery to open surgery.
Measured: during operation
Secondary outcomes (4)
Cosmetic appearance
according to (The Scar Cosmesis Assessment and Rating "SCAR" Scale)
Measured: 1 and 3 months after the surgery
Recurrence
recurrence of inguinal hernia diagnosed clinically and/or by ultrasound
Measured: 1 and 3 months after the surgery
Hydrocele
diagnosed clinically and/or by ultrasound
Measured: 1 and 3 months after the surgery
Testicular atrophy
diagnosed clinically and/or by ultrasound (postoperative imaging: > 50% loss of testicular volume or < 25% of volume of contralateral testis).
Measured: 1 and 3 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Nov 2024
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Model description
- evaluate the results of Needlescopic inguinal hernia repair in comparison with traditional laparoscopic repair in children as regard operative time, cosmetic appearance, recurrence and other complications
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelaziz Ali Abdelaziz, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660550
- Sponsor's protocol ID
- Soh-Med-15-10-4MS
- Status last verified
- Nov 2024
- First submitted
- 24 Oct 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Cóbar, J. P., & Nichol, P. F. (2023). Introduction of pediatric laparoscopic inguinal hernia repair in Guatemala. BMC Surgery, 23(1). 2. Chang, S., Chen, J. Y., Hsu, C., Chuang, F., & Yang, S. S. D. (2015). The incidence of inguinal hernia and associated risk factors of incarceration in pediatric inguinal hernia: a nation-wide longitudinal population-based study. Hernia, 20(4), 559-563. 3. Elhosary, M. A., Elbatarny, A. M., Arafa, M., Mahmoud, S. M., Ismail, K. A., et al. (2023). Needlescopic primary paediatric inguinal hernia repair by hernia sac disconnection and peritoneal closure. Journal of Pakistan Medical Association, 73(4), S61-S66. 4. Maat, S. C., Dreuning, K. M. A., Nordkamp, S., Van Gemert, W., Twisk, J. W. R., et al. (2021). Comparison of intra- and extra-corporeal laparoscopic hernia repair in children: A systematic review and pooled data-analysis. Journal of Pediatric Surgery, 56(9), 1647-1656. 5. Hajong, R., Newme, K., & Moirangthem, T. (2022). A case control study of needlescopic herniotomy versus open herniotomy in children. Journal of Family Medicine and Primary Care, 11(7), 3633. 6. Shalaby, R., Negm, M., Elsawaf, M., Elsaied, A., Shehata, S., et al. (2021). Needlescopic disconnection and peritoneal closure for Pediatric inguinal hernia repair: a Novel technique. Surgical Laparoscopy Endoscopy & Percutaneous Techniques, 32(2), 272-278. 7. Kantor J, et al. Reliability and photographic equivalency of the SCAR Cosmesis assessment and rating (SCAR) scale, an outcome measure for postoperative scars. JAMA Dermatol. 2017;153(1):55-60 8. Ein, S.H. ∙ Nasr, A. ∙ Wales, P.W. ... Testicular atrophy after attempted pediatric orchidopexy for true undescended testis J Pediatr Surg. 2014; 49:317-322.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needlescopic Versus Traditional Laparoscopic Inguinal Hernia Repair in Pediatrics (A Prospective Comparative Study)
- ClinicalTrials.gov ID
- NCT06660550
- Acronym / sponsor ID
- Soh-Med-15-10-4MS
- Conditions
- Congenital Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 28 Oct 2024 (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.
The aim of the study is to evaluate the results of Needlescopic inguinal hernia repair in comparison with traditional laparoscopic repair in children as regard operative time, cosmetic appearance, recurrence and other complications.
Detailed description
Patients and methods:
- Place of the study: The study will be held in Department of Pediatric surgery in Sohag University Hospital.
- Type of the study: Prospective comparative Cohort study.
- Duration of the study: The study will last for 6 to 9 months starting from the date of acceptance of the protocol.
- Ethical considerations: The study will be carried out after approval by scientific and ethical committees of Sohag faculty of medicine.
- Method of the study:
Preoperative assessment:
- Demographic data: e.g. name, age, sex …. etc.
- History: e.g. complaint, present history and past surgical and medical history…etc.
- General and local examination: e.g. laterality, associated anomalies …. etc.
- Investigations:
Routine labs. Imaging: to confirm diagnosis in the affected side, to evaluate contralateral side, bilateral testicular volume as volumetric stander to evaluate testicular atrophy postoperative and other anomalies.
Operative technique:
Operative steps:
- Traditional laparoscopic repair.
- STEPS:
- A 5mm port for the camera is introduced at umbilicus by open technique.
- Using triangulation rule to introduce two working ports.
- The abdomen is insufflated with carbon dioxide to 6-8 mmHg pressure in patients under 1 year of age and to 8-10 mmHg in older children.
- Diathermize the neck of the hernia sac with a diathermy hook.
- A 10-15 cm absorbable suture is passed into the peritoneal cavity through the abdominal wall next to the lateral port under vision.
- The purse-string stitch commences at the 2 o'clock position of the internal hernia opening.
- ensure that a "complete ring" of peritoneum has been included in the purse-string stitch without significant gaps.
- The purse-string suture is tied tightly using intracorporeally knot tying.
- Needlescopic Internal Ring Suturing.
- EQUIPMENT/SUTURE:
- One 5-mm trocar and 5-mm lens 30° or 0° telescope.
- Epidural needle.
- Non absorbable suture.
- Fascial closure instrument.
- STEPS:
- A 5mm port for the camera is introduced at umbilicus by open technique.
- The abdomen is insufflated with carbon dioxide to 6-8 mmHg pressure in patients under 1 year of age and to 8-10 mmHg in older children.
- The suture is introduced through the barrel of the epidural needle.
- Maintaining both ends of the preloaded suture extra peritoneal, the needle is advanced under the peritoneum around lateral half of the internal ring.
- The peritoneum is entered and the suture advanced into the abdominal cavity, creating a loop.
- Fascial closure instrument is introduced directly through anterior abdominal wall to help to maintain suture loop.
- The needle is removed, leaving the loop in place.
- The needle is entered again through the same skin puncture site around the medial half of the ring and enter the peritoneum, leaving a small space above the vas deferens and testicular vessels to avoid injury.
- The loop of suture is introduced into the hollow of the needle again and advance the suture into the first loop by the help of fascial closure.
- Withdraw the needle.
- Catch the suture end in the loop and withdraw them together then the suture is tied extra corporeally.
Patient outcomes:
Patients assessment and follow up:
- Primary outcome measures: Operative time. Intraoperative complication. Rate of conversion to open surgery.
- Secondary outcome measures:
1 and 3 months after the surgery to asses:
- Cosmetic appearance: according to (The Scar Cosmesis Assessment and Rating "SCAR" Scale) [7].
- Recurrence.
- Hydrocele.
- Testicular atrophy (postoperative imaging: > 50% loss of testicular volume or < 25% of volume of contralateral testis) [8].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- evaluate the results of Needlescopic inguinal hernia repair in comparison with traditional laparoscopic repair in children as regard operative time, cosmetic appearance, recurrence and other complications
| Arm | Type | Receives |
|---|---|---|
| Needlescopic inguinal hernia repair | Active comparator | Procedure: Needlescopic inguinal hernia repair |
| Traditional laparoscopic inguinal hernia repair | Active comparator | Procedure: laparoscopic inguinal hernia repair |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Include patients presented with inguinal hernia with age < 18 years.
Key exclusion criteria (3 listed)
- Age above 18 years.
- Complicated inguinal hernia (e.g. irreducibility, obstruction and strangulation).
- Pervious lower abdominal surgeries.
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 inguinal hernia repairtraditional laparoscopic repair | Procedure or surgery | Traditional laparoscopic inguinal hernia repair |
| Needlescopic inguinal hernia repairNeedlescopic inguinal hernia repair | Procedure or surgery | Needlescopic inguinal hernia repair |
Primary outcome
Operative time
Time frame: during operation
Operative time from start of incision making till end of operation and closure of incisions
Intraoperative complications
Time frame: during operation
as injury to inferior epigastric vessels, vas deferens and major pelvic vessels
Rate of conversion to open surgery.
Time frame: during operation
rate of conversion from laparoscopic surgery to open surgery.
4 secondary outcomes
Cosmetic appearance
Time frame: 1 and 3 months after the surgery
Recurrence
Time frame: 1 and 3 months after the surgery
Hydrocele
Time frame: 1 and 3 months after the surgery
Testicular atrophy
Time frame: 1 and 3 months after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background1. Cóbar, J. P., & Nichol, P. F. (2023). Introduction of pediatric laparoscopic inguinal hernia repair in Guatemala. BMC Surgery, 23(1). 2. Chang, S., Chen, J. Y., Hsu, C., Chuang, F., & Yang, S. S. D. (2015). The incidence of inguinal hernia and associated risk factors of incarceration in pediatric inguinal hernia: a nation-wide longitudinal population-based study. Hernia, 20(4), 559-563. 3. Elhosary, M. A., Elbatarny, A. M., Arafa, M., Mahmoud, S. M., Ismail, K. A., et al. (2023). Needlescopic primary paediatric inguinal hernia repair by hernia sac disconnection and peritoneal closure. Journal of Pakistan Medical Association, 73(4), S61-S66. 4. Maat, S. C., Dreuning, K. M. A., Nordkamp, S., Van Gemert, W., Twisk, J. W. R., et al. (2021). Comparison of intra- and extra-corporeal laparoscopic hernia repair in children: A systematic review and pooled data-analysis. Journal of Pediatric Surgery, 56(9), 1647-1656. 5. Hajong, R., Newme, K., & Moirangthem, T. (2022). A case control study of needlescopic herniotomy versus open herniotomy in children. Journal of Family Medicine and Primary Care, 11(7), 3633. 6. Shalaby, R., Negm, M., Elsawaf, M., Elsaied, A., Shehata, S., et al. (2021). Needlescopic disconnection and peritoneal closure for Pediatric inguinal hernia repair: a Novel technique. Surgical Laparoscopy Endoscopy & Percutaneous Techniques, 32(2), 272-278. 7. Kantor J, et al. Reliability and photographic equivalency of the SCAR Cosmesis assessment and rating (SCAR) scale, an outcome measure for postoperative scars. JAMA Dermatol. 2017;153(1):55-60 8. Ein, S.H. ∙ Nasr, A. ∙ Wales, P.W. ... Testicular atrophy after attempted pediatric orchidopexy for true undescended testis J Pediatr Surg. 2014; 49:317-322.
- Individual participant dataSharing planned: No
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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.
Ahmed M Abd El-Moniem, Professor contact
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 inguinal hernia repair and Needlescopic inguinal hernia repair in people with Congenital Inguinal Hernia, run by Sohag 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 3 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: looking for participants now, as of the sponsor's last update on 27 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelaziz A Abdelaziz, Resident (00201010274505, abdelazeez.ali@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: during operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06660550, which also lists 1 linked publication.
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 27 Nov 2024.