NCT04266561

Brief Summary

Laparoscopic management of recurrent inguinal hernia in children has been recently introduced in surgical practice. One of the most important advantages of using the laparoscopic approach in cases with recurrent inguinal hernia (RIH) is that it avoids the previous operation site thus avoiding injuries to the vas and vessels \[19\]. Some authors designed a study to compare laparoscopic hernia repairs with classical open repairs for pediatric RIH following the first open repair. They stated that avoiding the scarred tissue the former operation area with the laparoscopic approach facilitates the procedure and decreases both the operative time and complication rate. \[5\]. Further, it is as simple as a fresh hernia repair because the time taken for the repair of recurrent hernia laparoscopically was the same as the fresh laparoscopic repair with no added complication \[5,20\]. In laparoscopic surgery, approaching the hernia defect from within the abdomen, makes the area of interest bloodless, and the magnification renders anatomy very clear, making surgery precise \[6,7\].

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
5.6 years until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

3.1 years

First QC Date

June 24, 2014

Last Update Submit

February 10, 2020

Conditions

Congenital Hernia

Keywords

LaparoscopyRecurrent inguinal herniaChildren

Outcome Measures

Primary Outcomes (1)

  • Operative time

    The operative time is estimated by minutes. The estimated operative time for unilateral and bilateral recurrent hernia are estimated

    From the incision time to the closure of the wound

Secondary Outcomes (2)

  • Hydrocele formation

    one month postoperatively

  • Testicular atrophy

    three months postoperatively

Study Arms (1)

lap. recurent inguinal hernia repair

OTHER

After induction of general anesthesia, the patient was placed supine in Trendelenburg's position. Insertion of the main umbilical port. Laparoscopic hernia repair was done by intracorporeal insertion of purse string technique with some modifications

Other: hernia repair

Interventions

hernia repairOTHER

Two 3-mm needle holders were used for stitching the wide IIR. Then the suture was continued along the upper margin of IIR, but in a deeper plane to include the peritoneum and the deeper fascia transversalis.

lap. recurent inguinal hernia repair

Eligibility Criteria

Age6 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Recurrent inguinal hernia

You may not qualify if:

  • complicated inguinal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Housain University Hospital

Cairo, 11884, Egypt

Location

Related Publications (4)

  • Shalaby R, Ismail M, Dorgham A, Hefny K, Alsaied G, Gabr K, Abdelaziz M. Laparoscopic hernia repair in infancy and childhood: evaluation of 2 different techniques. J Pediatr Surg. 2010 Nov;45(11):2210-6. doi: 10.1016/j.jpedsurg.2010.07.004.

    PMID: 21034946BACKGROUND

  • 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.

    PMID: 16567212BACKGROUND

  • 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.

    PMID: 23326656BACKGROUND

  • Shalaby R, Desoky A. Needlescopic inguinal hernia repair in children. Pediatr Surg Int. 2002 Mar;18(2-3):153-6. doi: 10.1007/s003830100655.

    PMID: 11956783BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • Rafik Shalaby, MD

    Al-Azhar University, Nasr City, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2014

First Posted

February 12, 2020

Study Start

February 1, 2010

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

EG(1)