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Laparoscopic Inguinal Hernia Repair in Infancy and Childhood (LIHR-2014)

Primary Purpose

Congenital Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hernial sac ligation in continuity
Hernial sac disconnection
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Inguinal Hernia focused on measuring Laparoscopy, purse string, hernial sac

Eligibility Criteria

6 Months - 3 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Bilateral congenital inguinal hernia (CIH), recurrent cases, unilateral cases with questionable other side, parental request and cases with CIH associated with umbilical hernia.

Exclusion Criteria:

Hernia of canal of Nuck in females, Inguinal hernia with undescended testis, Parental refusal, Contraindications for laparoscopy as lower major abdominal surgery

Sites / Locations

  • Rafik Shalaby

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Hernial sac ligation in continuity

Hernial sac disconnection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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

Full Information

First Posted
February 26, 2014
Last Updated
January 17, 2020
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT02239185
Brief Title
Laparoscopic Inguinal Hernia Repair in Infancy and Childhood
Acronym
LIHR-2014
Official Title
Laparoscopic Inguinal Hernia Repair in Infancy and Childhood; a Prospective Controlled Randomized Study of Two Different Technique
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Inguinal Hernia
Keywords
Laparoscopy, purse string, hernial sac

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hernial sac ligation in continuity
Arm Type
Other
Arm Description
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.
Arm Title
Hernial sac disconnection
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hernial sac ligation in continuity
Other Intervention Name(s)
Purse string suture around IIR leaving the sac in continuity
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hernial sac disconnection
Other Intervention Name(s)
Laparoscopic disconnection of the hernial sac at IIR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence
Description
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
Time Frame
At 3 and 6 months post operatively
Secondary Outcome Measure Information:
Title
Operative time
Description
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.
Time Frame
intra operative time is measured from skin incision to skin closure
Title
Post operative hydrocele formation
Description
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
Time Frame
at 1 and 3 months post operatively

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bilateral congenital inguinal hernia (CIH), recurrent cases, unilateral cases with questionable other side, parental request and cases with CIH associated with umbilical hernia. Exclusion Criteria: Hernia of canal of Nuck in females, Inguinal hernia with undescended testis, Parental refusal, Contraindications for laparoscopy as lower major abdominal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafik MI Shalaby, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rafik Shalaby
City
Cairo
ZIP/Postal Code
11884
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
23326656
Citation
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.
Results Reference
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Laparoscopic Inguinal Hernia Repair in Infancy and Childhood

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