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

January 17, 2020 updated by: Rafik Shalaby, Al-Azhar University

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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Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11884
        • Rafik Shalaby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hernial sac ligation in continuity
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.
Procedure: Hernial sac ligation 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.
Other Names:
  • Purse string suture around IIR leaving the sac in continuity
Other: Hernial sac disconnection
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.
Procedure: Hernial sac disconnection
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.
Other Names:
  • Laparoscopic disconnection of the hernial sac at IIR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 3 and 6 months post operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: intra operative time is measured from skin incision to skin closure
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.
intra operative time is measured from skin incision to skin closure
Post operative hydrocele formation
Time Frame: at 1 and 3 months post operatively
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
at 1 and 3 months post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Rafik MI Shalaby, MD, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-2014
  • RAFIK-2014 (Registry Identifier: Al Azhar University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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