Congenital Inguinal HerniaLIHR-2014NCT02239185
Laparoscopic Inguinal Hernia Repair in Infancy and Childhood
A study testing Hernial sac ligation in continuity and Hernial sac disconnection in people with Congenital Inguinal Hernia, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Aim of the study The aim of this study is to test the hypothesis that during laparoscopic hernia repair, disconnection of the hernial sac along with suture ligation of the neck is better than transperitoneal purse string suture around the hernial sac at the neck leaving the sac in continuity. Read more about this study
- Who is it for?
- Ages 6 months to 3 years, men only
- Conditions the study is for
- Congenital Inguinal Hernia
- What is being tested?
- Hernial sac ligation in continuity and Hernial sac disconnection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- May 2012to Apr 2015
- 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 3 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Bilateral congenital inguinal hernia (CIH), recurrent cases, unilateral cases with questionable other side, parental request and cases with CIH associated with umbilical hernia.
Who cannot join
- Hernia of canal of Nuck in females, Inguinal hernia with undescended testis, Parental refusal, Contraindications for laparoscopy as lower major abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Inguinal Hernia Repair in Infancy and Childhood; a Prospective Controlled Randomized Study of Two Different Technique
Aim of the study The aim of this study is to test the hypothesis that during laparoscopic hernia repair, disconnection of the hernial sac along with suture ligation of the neck is better than transperitoneal purse string suture around the hernial sac at the neck leaving the sac in continuity. Also to compare the two different laparoscopic techniques as regards operative time, recurrence rate, hydrocele formation, and other possible complications as bleeding, hematoma, injury of the vas and testicular atrophy and post-operative cosmetic results.
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Read the detailed description
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee of our University. The procedures and the aim of the study are clearly explained to the patient and the family. A written informed consent is obtained before enrollment of the patients into the study. The family refusal to give consent for laparoscopic hernia repair by either technique does not deprive the patient from getting surgical care by open herniotomy
- In the 2 groups, after induction of general endotracheal tube anesthesia, the patient is positioned supine in Trendelenburg's position. Insertion of the main umbilical port [5-mm] by open technique will be done for 5-mm 30° telescope, then pneumoperitoneum will be created to a pressure of 8-12 mmHg.
Laparoscopy will be used for initial visualization of the pelvis and internal inguinal rings on both sides. In group I, the laparoscopic hernia repair will be done according to a technique described by Scheir Two 3-mm trocars are inserted under laparoscopic guidance at the level of umbilicus in mid-clavicular line on either side as working ports unilateral hernia, on the side of hernia can be little higher and opposite side little lower, for better triangulation. In infants and small babies, the working ports are placed little higher than the level of umbilicus.
Non absorbable 3-0 Prolene suture is used in all patients after its shortening to 8cm.length.
Group I, laparoscopic closure of hernia sac at internal inguinal ring in continuity using 3 - 0 non-absorbable purse-string suture. The spermatic vessels and vas deferens are well visualized and protected during the suture. In all cases, hydro dissection can be done by injection of saline to separate the peritoneum from cord structures. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying. The stitches included the peritoneum and the underlying muscular tissue lateral to the spermatic cord. The procedure is modified in children with a dilated internal ring. Ligature of the hernia sac at internal inguinal ring (IIR) is inadequate in such cases. Here, laparoscopic narrowing of IIR by few interrupted sutures will be done.
Group II, circumferential incision on the peritoneum at IIR will be started to separate hernia sac from the peritoneum. Initial disconnection of the vas and vessels will be done and then the peritoneum posterior to the internal ring will be divided and then the anterior disconnection will be carried out. Saline can be injected to separate the peritoneum from cord structures (hydro dissection). Care is taken not to damage the vas and vessels by handling them. Then the proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle. Closure: In both groups, supra-umbilical incision will be closed with polyglycolic acid 3-0 suture. Three mm trocar sites will be approximated with the steri-strips.
- Conditions
- Congenital Inguinal Hernia
- Being tested
- Hernial sac ligation in continuity, Hernial sac disconnection
- Keywords
- Laparoscopy, purse string, hernial sac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hernial sac ligation in continuityProcedure or surgery
Also called Purse string suture around IIR leaving the sac in continuity
Laparoscopic closure of hernia sac at internal inguinal ring in continuity using 3 - 0 non-absorbable purse-string suture. The spermatic vessels and vas deferens are well visualized and protected during the suture. In all cases, hydro dissection can be done by injection of saline to separate the peritoneum from cord structures. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying. The stitches included the peritoneum and the underlying muscular tissue lateral to the spermatic cord. The procedure is modified in children with a dilated internal ring.
Hernial sac disconnectionProcedure or surgery
Also called Laparoscopic disconnection of the hernial sac at IIR
Circumferential incision on the peritoneum at IIR will be started to separate hernia sac from the peritoneum. Initial disconnection of the vas and vessels will be done and then the peritoneum posterior to the internal ring will be divided and then the anterior disconnection will be carried out. Saline can be injected to separate the peritoneum from cord structures (hydro dissection). Care is taken not to damage the vas and vessels by handling them. Then the proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle.
| Study group | Role | What they receive |
|---|---|---|
| Hernial sac ligation in continuity | Other | laparoscopic closure of hernia sac in continuity using 3 - 0 non-absorbable purse-string suture. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying. Receives: Procedure: Hernial sac ligation in continuity |
| Hernial sac disconnection | Other | circumferential incision on the peritoneum at internal inguinal ring (IIR) with separation of hernia sac from the peritoneum. The proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle. Receives: Procedure: Hernial sac disconnection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
All Patients will be subjected to post operative clinical examination and scrotal U/S for assessment of the recurrence. Recurrence is identified by visual of a bulg at the site of hernia on crying and the presence of defect more than 4 mm. In diameter
Measured: At 3 and 6 months post operatively
Secondary outcomes (2)
Operative time
The operative time will be measured by minutes in both group. The operative time is measured from skin incision to skin closure. It does not enclude induction and recovery of anesthesia.
Measured: intra operative time is measured from skin incision to skin closure
Post operative hydrocele formation
Post operative hydrocele formation is evaluated by clinical and U/S examination. It is measured by milliter of fluids in the tunica vaginalis around the testis
Measured: at 1 and 3 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startMay 2012
- Primary completionMar 2015
- Study completionApr 2015
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 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
- 90 participants (actual)
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 MI Shalaby, MD, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239185
- Sponsor's protocol ID
- CTP-2014
- Other IDs
- RAFIK-2014
- Acronym
- LIHR-2014
- Status last verified
- Jan 2020
- First submitted
- 26 Feb 2014
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Shalaby R, Ibrahem R, Shahin M, Yehya A, Abdalrazek M, Alsayaad I, Shouker MA. Laparoscopic Hernia Repair versus Open Herniotomy in Children: A Controlled Randomized Study. Minim Invasive Surg. 2012;2012:484135. doi: 10.1155/2012/484135. Epub 2012 Dec 27.
PubMed 23326656
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Inguinal Hernia Repair in Infancy and Childhood; a Prospective Controlled Randomized Study of Two Different Technique
- ClinicalTrials.gov ID
- NCT02239185
- Acronym / sponsor ID
- LIHR-2014 / CTP-2014
- Conditions
- Congenital Inguinal Hernia
- Keywords
- Laparoscopy, purse string, hernial sac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Sep 2014 (estimated)
- 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.
Aim of the study The aim of this study is to test the hypothesis that during laparoscopic hernia repair, disconnection of the hernial sac along with suture ligation of the neck is better than transperitoneal purse string suture around the hernial sac at the neck leaving the sac in continuity. Also to compare the two different laparoscopic techniques as regards operative time, recurrence rate, hydrocele formation, and other possible complications as bleeding, hematoma, injury of the vas and testicular atrophy and post-operative cosmetic results.
..
Detailed description
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee of our University. The procedures and the aim of the study are clearly explained to the patient and the family. A written informed consent is obtained before enrollment of the patients into the study. The family refusal to give consent for laparoscopic hernia repair by either technique does not deprive the patient from getting surgical care by open herniotomy
- In the 2 groups, after induction of general endotracheal tube anesthesia, the patient is positioned supine in Trendelenburg's position. Insertion of the main umbilical port [5-mm] by open technique will be done for 5-mm 30° telescope, then pneumoperitoneum will be created to a pressure of 8-12 mmHg.
Laparoscopy will be used for initial visualization of the pelvis and internal inguinal rings on both sides. In group I, the laparoscopic hernia repair will be done according to a technique described by Scheir Two 3-mm trocars are inserted under laparoscopic guidance at the level of umbilicus in mid-clavicular line on either side as working ports unilateral hernia, on the side of hernia can be little higher and opposite side little lower, for better triangulation. In infants and small babies, the working ports are placed little higher than the level of umbilicus.
Non absorbable 3-0 Prolene suture is used in all patients after its shortening to 8cm.length.
Group I, laparoscopic closure of hernia sac at internal inguinal ring in continuity using 3 - 0 non-absorbable purse-string suture. The spermatic vessels and vas deferens are well visualized and protected during the suture. In all cases, hydro dissection can be done by injection of saline to separate the peritoneum from cord structures. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying. The stitches included the peritoneum and the underlying muscular tissue lateral to the spermatic cord. The procedure is modified in children with a dilated internal ring. Ligature of the hernia sac at internal inguinal ring (IIR) is inadequate in such cases. Here, laparoscopic narrowing of IIR by few interrupted sutures will be done.
Group II, circumferential incision on the peritoneum at IIR will be started to separate hernia sac from the peritoneum. Initial disconnection of the vas and vessels will be done and then the peritoneum posterior to the internal ring will be divided and then the anterior disconnection will be carried out. Saline can be injected to separate the peritoneum from cord structures (hydro dissection). Care is taken not to damage the vas and vessels by handling them. Then the proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle. Closure: In both groups, supra-umbilical incision will be closed with polyglycolic acid 3-0 suture. Three mm trocar sites will be approximated with the steri-strips.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hernial sac ligation in continuity | Other | Procedure: Hernial sac ligation in continuitylaparoscopic closure of hernia sac in continuity using 3 - 0 non-absorbable purse-string suture. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying. |
| Hernial sac disconnection | Other | Procedure: Hernial sac disconnectioncircumferential incision on the peritoneum at internal inguinal ring (IIR) with separation of hernia sac from the peritoneum. The proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle. |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Bilateral congenital inguinal hernia (CIH), recurrent cases, unilateral cases with questionable other side, parental request and cases with CIH associated with umbilical hernia.
Key exclusion criteria (1 listed)
- Hernia of canal of Nuck in females, Inguinal hernia with undescended testis, Parental refusal, Contraindications for laparoscopy as lower major abdominal surgery
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 |
|---|---|---|
| Hernial sac ligation in continuityAlso: Purse string suture around IIR leaving the sac in continuityLaparoscopic closure of hernia sac at internal inguinal ring in continuity using 3 - 0 non-absorbable purse-string suture. The spermatic vessels and vas deferens are well visualized and protected during the suture. In all cases, hydro dissection can be done by injection of saline to separate the peritoneum from cord structures. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying. The stitches included the peritoneum and the underlying muscular tissue lateral to the spermatic cord. The procedure is modified in children with a dilated internal ring. | Procedure or surgery | Hernial sac ligation in continuity |
| Hernial sac disconnectionAlso: Laparoscopic disconnection of the hernial sac at IIRCircumferential incision on the peritoneum at IIR will be started to separate hernia sac from the peritoneum. Initial disconnection of the vas and vessels will be done and then the peritoneum posterior to the internal ring will be divided and then the anterior disconnection will be carried out. Saline can be injected to separate the peritoneum from cord structures (hydro dissection). Care is taken not to damage the vas and vessels by handling them. Then the proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle. | Procedure or surgery | Hernial sac disconnection |
Primary outcome
Recurrence
Time frame: At 3 and 6 months post operatively
All Patients will be subjected to post operative clinical examination and scrotal U/S for assessment of the recurrence. Recurrence is identified by visual of a bulg at the site of hernia on crying and the presence of defect more than 4 mm. In diameter
2 secondary outcomes
Operative time
Time frame: intra operative time is measured from skin incision to skin closure
Post operative hydrocele formation
Time frame: at 1 and 3 months post operatively
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 21 Jan 2020.
- Background: PubMed 23326656Shalaby R, Ibrahem R, Shahin M, Yehya A, Abdalrazek M, Alsayaad I, Shouker MA. Laparoscopic Hernia Repair versus Open Herniotomy in Children: A Controlled Randomized Study. Minim Invasive Surg. 2012;2012:484135. doi: 10.1155/2012/484135. Epub 2012 Dec 27.
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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.
Rafik MI Shalaby, MD principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hernial sac ligation in continuity and Hernial sac disconnection in people with Congenital Inguinal Hernia, run by Al-Azhar 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 21 Jan 2020. 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?
Recurrence (time frame: At 3 and 6 months post operatively). 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 NCT02239185, 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 21 Jan 2020.