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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04266561
Other study ID # CTP-30121949
Secondary ID Rafik-2015
Status Completed
Phase N/A
First received
Last updated
Start date February 2010
Est. completion date July 2013

Study information

Verified date February 2020
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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].


Description:

Abstract: Background: Open repair of recurrent inguinal hernias [RIH] in infancy and childhood is difficult and there is definite risk of damaging the vas deferens and testicular vessels. Laparoscopic repair of RIH has the benefit of avoiding the previous operative site. The aim of this study is to present the investigator's experience with laparoscopic repair of RIH either after open or laparoscopic hernia repair with stress on technical refinements to prevent recurrence. Patients and methods: This is a retrospective study of laparoscopic repair of recurrent inguinal hernia. Records of patients that have been subjected to laparoscopic inguinal hernia repair for RIH were reviewed and evaluated. All patients were subjected to laparoscopic repair of 42 recurrent hernial defects. The primary outcome measurements of this study include; operative time. The secondary outcomes include; hydrocele formation, iatrogenic ascent of the testis and testicular atrophy.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date July 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 6 Months to 4 Years
Eligibility Inclusion Criteria:

- Recurrent inguinal hernia

Exclusion Criteria:

- complicated inguinal hernia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
hernia repair
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.

Locations

Country Name City State
Egypt Al-Housain University Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Shalaby R, Desoky A. Needlescopic inguinal hernia repair in children. Pediatr Surg Int. 2002 Mar;18(2-3):153-6. — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hydrocele formation Clinical and ultrasound examination of the scrotum. Hydrocele is diagnosed by the presence of fluids in the tunica albugenia around the testis. It is measured by ml liter one month postoperatively
Secondary Testicular atrophy Clinical and ultrasound examination of the testis for estimation of testicular size in cm. three months postoperatively