Congenital Inguinal HerniaNCT04372212
Needlescopic Inversion and Snaring Versus Ligation of Hernia Sac in Girls
A study testing Hernia sac inversion and Snaring in people with Congenital Inguinal Hernia and Hernia Sac, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
Failure of closure of the processus vaginalis during intrauterine life will result in congenital inguinal hernia [CIH]. Exact incidence of CIH in children is not known but it has been reported between 1-5 %. In premature babies, the incidence may reach up to 15-30%. Read more about this study
- Who is it for?
- Ages 6 months to 12 years, women only
- Conditions the study is for
- Congenital Inguinal Hernia, Hernia Sac, Recurrent Hernia
- What is being tested?
- Hernia sac inversion and Snaring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 21 Mar 2020to Jul 2021
- 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 6 months to 12 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Female patients with congenital inguinal hernia (unilateral or bilateral) Hernia defect less than 1.5 cm. Age: from 6 months to 10 years old
Who cannot join
- Male patients Female patients with recurrent inguinal hernia Females below 6-Month Hernia defect more than 1.5 cm.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Al-Azhar Faculty of Medicine
Cairo
Rafik Shalaby, MD, 01000722072, rafikshalaby40@gmail.com
- Recruiting
Faculty of Medicine
Tanta
Mohamed I Elsawaf, MD, mohamed_elsawaf@med.tanta.edu.eg
About this study
Official title: Needlescopic Inversion and Snaring Versus Needlescopic Inversion and Ligation of Hernia Sac for Inguinal Hernia Repair in Girls
Failure of closure of the processus vaginalis during intrauterine life will result in congenital inguinal hernia [CIH]. Exact incidence of CIH in children is not known but it has been reported between 1-5 %. In premature babies, the incidence may reach up to 15-30%. Congenital inguinal hernia is more common in boys than girls, ranging from 4:1 to 10:1 [1].
Although the open inguinal herniotomy and high ligation of the sac is the gold standard line of the treatment, Laparoscopic inguinal hernia repair become a good option. The laparoscopy has many advantages that it is simple, feasible, and safe with detection of the contralateral hernia and other hernias. In addition to laparoscopy results in excellent cosmetic results low wound infection, less pain, and short hospital stay.
Read more
The non-division of the hernia sac in during laparoscopic hernia repair may be the cause of recurrence and postoperative hydrocele [5]. Division of hernia sac and suturing of proximal part at IIR; is modification of the laparoscopic technique which mimic what happen during open herniotomy. Some authors resected the processus vaginalis and closed the inguinal ring for the repair of CIH. They claimed that they have excellent results with low recurrence.One author described a technique based on the theory that CIH is due to a patent processus vaginalis, and therefore, the procedure should be to entirely resect it, with or without closure of the internal ring. This allows the peritoneal scar tissue to close the area of the ring. Also, this scarring occurs in the extent of the inguinal canal where the dissection took place, therefore causing the same peritoneal scarring and sealing of the inguinal floor with complete resolution of the problem.
However, a few studies address the superiority of technique over the other and to date there is no controlled randomized study to compare needlescopic disconnection of the hernia sac and closure of the peritoneum at IIR versus disconnection without closure of the peritoneum.
Read the detailed description
Description of the Procedure:
Instruments: 5-mm trocar and 5-mm 30° telescope, single 2-mm reusable port, two 14-G (1.6-mm) suture grasper devices [SGD] [Mediflex Company, Islandia, New York, USA], Home made isolated diathermy probe and an endoscopic polypectomy snare [SN]. SN is modified by shortening from 2-m to 70-cm. It fits directly in 2-mm port.
Operative details: Patient lies in supine position at upper part of OR table towards right edge. OR table tilted to opposite side of hernia with 30- degree Trendelenburg position. Operator stands on patient's right side during either uni-or bi-lateral hernia. Camera man stands at table head and monitor facing patient's feet.
Povidone Iodine solution was applied from nipple to mid-thigh and child is then draped. Vertical trans umbilical 5-mm incision is made and 5mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min keeping intraabdominal pressure between 8-12 mmHg according to age and weight. Two-mm incision at point (A) located at junction of upper 1/3 and lower 2/3 of line extending between umbilicus and symphysis pubis for 2mm port passed under direct vision. A 1.6-mm 11-blade scalpel puncture 2- cm. above the corresponding Mc-Burney's Point (B) for SGD. Abdomen is explored to confirm the diagnosis and detect bilateral hernia if present.
One SGD was introduced through point A (SGD-A) and another] one through point B (SGD-B). Both SGDs were used to invert the hernia sac by gradual sustained alternating traction on the round ligament. Each SGD hands to the other one till complete inversion occurs, this is known by the sac hanging from internal ring without retracting-back inside the inguinal canal. At this point, snare (SN) is passed from the trocar at point A in the place of SGD-A and opened inside the abdomen. SGD-B passes inside the loop of SN and re-catches the hernia sac, which is then twisted around its neck several time. SN is closed tightly and diathermy current is applied to it leading to separation of hernia sac at the proper neck. [2-4]Detached sac (grasped by SGD-B) is then pushed antigradely out through the umbilical port. Deflation of the abdomen is done and umbilical fascial incision was closed using 2/0 or 3/0 Vicryl and umbilical skin layers were closed using 4/0 Vicryl.
Group B; The above operative details will be applied but the inverted twisted sac will be ligated by a home made 3/0 Vicry suture endoloop befor excision and extraction [5].
- Conditions
- Congenital Inguinal Hernia, Hernia Sac, Recurrent Hernia, Round Ligament; Injury, Fallopian Tube Injury, Ovarian Injury
- Being tested
- Hernia sac inversion and Snaring
- Medical subject headings
- Hernia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hernia sac inversion and SnaringDevice
Vertical trans umbilical 5-mm incision [Point A] is made and 5-mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min.
Both SGDs were used to invert the hernia sac. Then, modified polypectomy snare (SN) was introduced via the trocar at point B and opened inside the abdomen. SGD-C passed inside the loop of SN and re-catches the hernial sac, which was then twisted around its neck several times. SN was closed tightly at the proper neck and coagulation diathermy current was applied to it leading to separation of the hernia sac. Detached sac (grasped by SGD-C) is then pushed antegradely out through the umbilical port.
| Study group | Role | What they receive |
|---|---|---|
| Inversion and Snaring | Active comparator | Vertical trans umbilical 5-mm incision [Point A] is made and 5-mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min.
Both SGDs were used to invert the hernia sac. Then, modified polypectomy snare (SN) was introduced via the trocar at point B and opened inside the abdomen. SGD-C passed inside the loop of SN and re-catches the hernial sac, which was then twisted around its neck several times. SN was closed tightly at the proper neck and coagulation diathermy current was applied to it leading to separation of the hernia sac. Detached sac (grasped by SGD-C) is then pushed antegradely out through the umbilical port. Receives: Device: Hernia sac inversion and Snaring |
| Inversion and Ligation | Active comparator | Vertical trans umbilical 5-mm incision [Point A] is made and 5-mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min.
Both SGDs were used to invert the hernia sac. Then, modified polypectomy snare (SN) was introduced via the trocar at point B and opened inside the abdomen. SGD-C passed inside the loop of SN and re-catches the hernial sac, which was then twisted around its neck several times. SN was closed tightly at the proper neck and coagulation diathermy current was applied to it leading to separation of the hernia sac. Detached sac (grasped by SGD-C) is then pushed antegradely out through the umbilical port. Receives: Device: Hernia sac inversion and Snaring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of hernia [time frame]
All the patient will be examined during the period of the follow up to check the recurrence of hernia by clinical examination and inguino-scrotal U/S
Measured: at 1,2,3,6,10 and at12 moth
Secondary outcomes (2)
cosmetic
the parent satisfaction will be reported. A scale from 1 to 5 was applied where 1=bad result, 2=fair result, 3=good results, 4 = very good result and 5= excellent result
Measured: At 3,6,12 month
Operative time
the operative time will be measured by minutes from the start of skin incision till skin closure [from skin to skin]
Measured: At the first day of operation in minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start21 Mar 2020
- Primary completionMar 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Al-Azhar 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafik Shalaby, Al-Azhar University
- Investigators
- Rafik Y Shalaby, MD, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372212
- Sponsor's protocol ID
- PS2020-1001
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: There is a plan to make IPD and related data dictionaries available
Publications
Shalaby RY, Fawy M, Soliman SM, Dorgham A. A new simplified technique for needlescopic inguinal herniorrhaphy in children. J Pediatr Surg. 2006 Apr;41(4):863-7. doi: 10.1016/j.jpedsurg.2005.12.042.
PubMed 16567212Wantz GE. Testicular atrophy as a risk inguinal hernioplasty. Surg Gynecol Obstet. 1982 Apr;154(4):570-1.
PubMed 7064092Niyogi A, Tahim AS, Sherwood WJ, De Caluwe D, Madden NP, Abel RM, Haddad MJ, Clarke SA. A comparative study examining open inguinal herniotomy with and without hernioscopy to laparoscopic inguinal hernia repair in a pediatric population. Pediatr Surg Int. 2010 Apr;26(4):387-92. doi: 10.1007/s00383-010-2549-x. Epub 2010 Feb 9.
PubMed 20143077
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needlescopic Inversion and Snaring Versus Needlescopic Inversion and Ligation of Hernia Sac for Inguinal Hernia Repair in Girls
- ClinicalTrials.gov ID
- NCT04372212
- Acronym / sponsor ID
- PS2020-1001
- Conditions
- Congenital Inguinal Hernia, Hernia Sac, Recurrent Hernia, Round Ligament; Injury, Fallopian Tube Injury, Ovarian Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 21 Mar 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 1 May 2020 (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.
Failure of closure of the processus vaginalis during intrauterine life will result in congenital inguinal hernia [CIH]. Exact incidence of CIH in children is not known but it has been reported between 1-5 %. In premature babies, the incidence may reach up to 15-30%. Congenital inguinal hernia is more common in boys than girls, ranging from 4:1 to 10:1 [1].
Although the open inguinal herniotomy and high ligation of the sac is the gold standard line of the treatment, Laparoscopic inguinal hernia repair become a good option. The laparoscopy has many advantages that it is simple, feasible, and safe with detection of the contralateral hernia and other hernias. In addition to laparoscopy results in excellent cosmetic results low wound infection, less pain, and short hospital stay.
The non-division of the hernia sac in during laparoscopic hernia repair may be the cause of recurrence and postoperative hydrocele [5]. Division of hernia sac and suturing of proximal part at IIR; is modification of the laparoscopic technique which mimic what happen during open herniotomy. Some authors resected the processus vaginalis and closed the inguinal ring for the repair of CIH. They claimed that they have excellent results with low recurrence.One author described a technique based on the theory that CIH is due to a patent processus vaginalis, and therefore, the procedure should be to entirely resect it, with or without closure of the internal ring. This allows the peritoneal scar tissue to close the area of the ring. Also, this scarring occurs in the extent of the inguinal canal where the dissection took place, therefore causing the same peritoneal scarring and sealing of the inguinal floor with complete resolution of the problem.
However, a few studies address the superiority of technique over the other and to date there is no controlled randomized study to compare needlescopic disconnection of the hernia sac and closure of the peritoneum at IIR versus disconnection without closure of the peritoneum.
Detailed description
Description of the Procedure:
Instruments: 5-mm trocar and 5-mm 30° telescope, single 2-mm reusable port, two 14-G (1.6-mm) suture grasper devices [SGD] [Mediflex Company, Islandia, New York, USA], Home made isolated diathermy probe and an endoscopic polypectomy snare [SN]. SN is modified by shortening from 2-m to 70-cm. It fits directly in 2-mm port.
Operative details: Patient lies in supine position at upper part of OR table towards right edge. OR table tilted to opposite side of hernia with 30- degree Trendelenburg position. Operator stands on patient's right side during either uni-or bi-lateral hernia. Camera man stands at table head and monitor facing patient's feet.
Povidone Iodine solution was applied from nipple to mid-thigh and child is then draped. Vertical trans umbilical 5-mm incision is made and 5mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min keeping intraabdominal pressure between 8-12 mmHg according to age and weight. Two-mm incision at point (A) located at junction of upper 1/3 and lower 2/3 of line extending between umbilicus and symphysis pubis for 2mm port passed under direct vision. A 1.6-mm 11-blade scalpel puncture 2- cm. above the corresponding Mc-Burney's Point (B) for SGD. Abdomen is explored to confirm the diagnosis and detect bilateral hernia if present.
One SGD was introduced through point A (SGD-A) and another] one through point B (SGD-B). Both SGDs were used to invert the hernia sac by gradual sustained alternating traction on the round ligament. Each SGD hands to the other one till complete inversion occurs, this is known by the sac hanging from internal ring without retracting-back inside the inguinal canal. At this point, snare (SN) is passed from the trocar at point A in the place of SGD-A and opened inside the abdomen. SGD-B passes inside the loop of SN and re-catches the hernia sac, which is then twisted around its neck several time. SN is closed tightly and diathermy current is applied to it leading to separation of hernia sac at the proper neck. [2-4]Detached sac (grasped by SGD-B) is then pushed antigradely out through the umbilical port. Deflation of the abdomen is done and umbilical fascial incision was closed using 2/0 or 3/0 Vicryl and umbilical skin layers were closed using 4/0 Vicryl.
Group B; The above operative details will be applied but the inverted twisted sac will be ligated by a home made 3/0 Vicry suture endoloop befor excision and extraction [5].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inversion and Snaring | Active comparator | Device: Hernia sac inversion and SnaringVertical trans umbilical 5-mm incision [Point A] is made and 5-mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min. Both SGDs were used to invert the hernia sac. Then, modified polypectomy snare (SN) was introduced via the trocar at point B and opened inside the abdomen. SGD-C passed inside the loop of SN and re-catches the hernial sac, which was then twisted around its neck several times. SN was closed tightly at the proper neck and coagulation diathermy current was applied to it leading to separation of the hernia sac. Detached sac (grasped by SGD-C) is then pushed antegradely out through the umbilical port. |
| Inversion and Ligation | Active comparator | Device: Hernia sac inversion and SnaringVertical trans umbilical 5-mm incision [Point A] is made and 5-mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min. Both SGDs were used to invert the hernia sac. Then, modified polypectomy snare (SN) was introduced via the trocar at point B and opened inside the abdomen. SGD-C passed inside the loop of SN and re-catches the hernial sac, which was then twisted around its neck several times. SN was closed tightly at the proper neck and coagulation diathermy current was applied to it leading to separation of the hernia sac. Detached sac (grasped by SGD-C) is then pushed antegradely out through the umbilical port. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Female patients with congenital inguinal hernia (unilateral or bilateral) Hernia defect less than 1.5 cm. Age: from 6 months to 10 years old
Key exclusion criteria (1 listed)
- Male patients Female patients with recurrent inguinal hernia Females below 6-Month Hernia defect more than 1.5 cm.
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 |
|---|---|---|
| Hernia sac inversion and SnaringVertical trans umbilical 5-mm incision [Point A] is made and 5-mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min. Both SGDs were used to invert the hernia sac. Then, modified polypectomy snare (SN) was introduced via the trocar at point B and opened inside the abdomen. SGD-C passed inside the loop of SN and re-catches the hernial sac, which was then twisted around its neck several times. SN was closed tightly at the proper neck and coagulation diathermy current was applied to it leading to separation of the hernia sac. Detached sac (grasped by SGD-C) is then pushed antegradely out through the umbilical port. | Device | Inversion and Ligation, Inversion and Snaring |
Primary outcome
Recurrence of hernia [time frame]
Time frame: at 1,2,3,6,10 and at12 moth
All the patient will be examined during the period of the follow up to check the recurrence of hernia by clinical examination and inguino-scrotal U/S
2 secondary outcomes
cosmetic
Time frame: At 3,6,12 month
Operative time
Time frame: At the first day of operation in minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Results publication: PubMed 16567212Shalaby RY, Fawy M, Soliman SM, Dorgham A. A new simplified technique for needlescopic inguinal herniorrhaphy in children. J Pediatr Surg. 2006 Apr;41(4):863-7. doi: 10.1016/j.jpedsurg.2005.12.042.
- Results publication: PubMed 7064092Wantz GE. Testicular atrophy as a risk inguinal hernioplasty. Surg Gynecol Obstet. 1982 Apr;154(4):570-1.
- Results publication: PubMed 20143077Niyogi A, Tahim AS, Sherwood WJ, De Caluwe D, Madden NP, Abel RM, Haddad MJ, Clarke SA. A comparative study examining open inguinal herniotomy with and without hernioscopy to laparoscopic inguinal hernia repair in a pediatric population. Pediatr Surg Int. 2010 Apr;26(4):387-92. doi: 10.1007/s00383-010-2549-x. Epub 2010 Feb 9.
- Individual participant dataSharing planned: Yes. Yes: There is a plan to make IPD and related data dictionaries available
Related trials for Congenital Inguinal Hernia
Not yet recruiting
Recover@Home Postoperative Follow-up Study
Hernia, Inguinal, Hernia, Femoral
Active, not recruitingObservational study
INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA
Indirect Inguinal Hernia, Undescended Testis
Not yet recruitingPhase 4
Comparing the Synergistic Effect of Caudal Dexmedetomidine and Propofol Versus Caudal Dexmedetomidine Only or Propofol Only in Prevention of Sevoflurane Related Emergence Agitation in Pediatric Patients Undergoing Congenital Inguinal Hernia Repair
Sevoflurane Agitiion in Pediatric
Recruiting
Needlescopic Versus Traditional Laparoscopic Inguinal Hernia Repair in Pediatrics
Congenital Inguinal Hernia
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.
Rafik Y Shalaby, MD principal investigator
Al-Azhar University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hernia sac inversion and Snaring in people with Congenital Inguinal Hernia and Hernia Sac, run by Al-Azhar University at 2 sites 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: status not confirmed, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafik Y Shalaby, MD (01000722072, rafikshalaby40@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of hernia [time frame] (time frame: at 1,2,3,6,10 and at12 moth). 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 NCT04372212, which also lists 3 linked publications.
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 7 May 2020.