Needlescopic Versus Traditional Laparoscopic Inguinal Hernia Repair in Pediatrics

NCT06660550 | Recruiting

• 1 other identifier: Soh-Med-15-10-4MS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the results of Needlescopic inguinal hernia repair in comparison with traditional laparoscopic repair in children as regard operative time, cosmetic appearance, recurrence and other complications.

Conditions

Congenital Inguinal Hernia

Outcome Measures

Primary Outcomes (3)

• Operative time

  Operative time from start of incision making till end of operation and closure of incisions

  during operation

• Intraoperative complications

  as injury to inferior epigastric vessels, vas deferens and major pelvic vessels

  during operation

• Rate of conversion to open surgery.

  rate of conversion from laparoscopic surgery to open surgery.

  during operation

Secondary Outcomes (4)

• Cosmetic appearance

  1 and 3 months after the surgery

• Recurrence

  1 and 3 months after the surgery

• Hydrocele

  1 and 3 months after the surgery

• Testicular atrophy

  1 and 3 months after the surgery

Study Arms (2)

Needlescopic inguinal hernia repair

ACTIVE COMPARATOR

Procedure: Needlescopic inguinal hernia repair

Traditional laparoscopic inguinal hernia repair

ACTIVE COMPARATOR

Procedure: laparoscopic inguinal hernia repair

Interventions

laparoscopic inguinal hernia repair PROCEDURE

traditional laparoscopic repair

Traditional laparoscopic inguinal hernia repair

Needlescopic inguinal hernia repair PROCEDURE

Needlescopic inguinal hernia repair

Needlescopic inguinal hernia repair

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Include patients presented with inguinal hernia with age \< 18 years.

You may not qualify if:

• Age above 18 years.
• Complicated inguinal hernia (e.g. irreducibility, obstruction and strangulation).
• Pervious lower abdominal surgeries.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, Egypt

RECRUITING

Related Publications (1)

• 1. Cóbar, J. P., & Nichol, P. F. (2023). Introduction of pediatric laparoscopic inguinal hernia repair in Guatemala. BMC Surgery, 23(1). 2. Chang, S., Chen, J. Y., Hsu, C., Chuang, F., & Yang, S. S. D. (2015). The incidence of inguinal hernia and associated risk factors of incarceration in pediatric inguinal hernia: a nation-wide longitudinal population-based study. Hernia, 20(4), 559-563. 3. Elhosary, M. A., Elbatarny, A. M., Arafa, M., Mahmoud, S. M., Ismail, K. A., et al. (2023). Needlescopic primary paediatric inguinal hernia repair by hernia sac disconnection and peritoneal closure. Journal of Pakistan Medical Association, 73(4), S61-S66. 4. Maat, S. C., Dreuning, K. M. A., Nordkamp, S., Van Gemert, W., Twisk, J. W. R., et al. (2021). Comparison of intra- and extra-corporeal laparoscopic hernia repair in children: A systematic review and pooled data-analysis. Journal of Pediatric Surgery, 56(9), 1647-1656. 5. Hajong, R., Newme, K., & Moirangthem, T. (2022). A case control study of needlescopic herniotomy versus open herniotomy in children. Journal of Family Medicine and Primary Care, 11(7), 3633. 6. Shalaby, R., Negm, M., Elsawaf, M., Elsaied, A., Shehata, S., et al. (2021). Needlescopic disconnection and peritoneal closure for Pediatric inguinal hernia repair: a Novel technique. Surgical Laparoscopy Endoscopy & Percutaneous Techniques, 32(2), 272-278. 7. Kantor J, et al. Reliability and photographic equivalency of the SCAR Cosmesis assessment and rating (SCAR) scale, an outcome measure for postoperative scars. JAMA Dermatol. 2017;153(1):55-60 8. Ein, S.H. ∙ Nasr, A. ∙ Wales, P.W. ... Testicular atrophy after attempted pediatric orchidopexy for true undescended testis J Pediatr Surg. 2014; 49:317-322.

  BACKGROUND

Central Study Contacts

Abdelaziz A Abdelaziz, Resident

CONTACT

00201010274505; abdelazeez.ali@med.sohag.edu.eg

Ahmed M Abd El-Moniem, Professor

CONTACT

00201005768450

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.B.Ch., Resident in Pediatric Surgery Department Sohag University Hospitals

Model Details: evaluate the results of Needlescopic inguinal hernia repair in comparison with traditional laparoscopic repair in children as regard operative time, cosmetic appearance, recurrence and other complications

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)