Outcome of Laparoscopic Inguinal Herniorraphy in Children

NCT02310958 | Completed

• 1 other identifier: EKNZ2014-247
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators plan a retrospective, single-center outcome analysis of laparoscopic hernia repair in children operated between March 2nd, 2010, and March 1st, 2014. Data analysis will be based on a review of hospital records and a questionnaire answered by families. Patient demographics (age, gender), affected side, type and duration of laparoscopic intervention, and outcome parameters (hernia recurrence, post-operative complications, eg. infections, length and type of postoperative pain medication, and length of the postoperative hospital stay) will be analysed.

Conditions

Hernia, Inguinal

Keywords

Lapraroscopic surgical procedure; infant; complications; inguinal hernia; hernia recurrence

Outcome Measures

Primary Outcomes (1)

• Inguinal hernia recurrence

  Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months

Secondary Outcomes (4)

• postoperative complications (infections)

  Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months

• length of hospital stay

  Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months

• type of pain medication and duration of use after surgical procedure

  Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months

• metachronous hernia occurrence

  Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months

Study Arms (1)

Children with inguinal hernia

Laparoscopic surgical hernia repair in children aged between 1 day and 16 years

Procedure: Laparoscopic surgical hernia repair

Interventions

Laparoscopic surgical hernia repair PROCEDURE

Laparoscopic surgical hernia repair in children

Children with inguinal hernia

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged between 1 day and 16 years who underwent laparoscopic surgical inguinal hernia repair between March 2010 and March 2014 at a single institution.

You may qualify if:

• Children aged between 1 day and 16 years who underwent a laparoscopic surgical procedure for correction of unilateral or bilateral inguinal hernia or recurrent inguinal hernia at a single institution

You may not qualify if:

• age of patient more than 16 years
• patients suffering from neuromuscular, chronic abdominal, chronic pulmonary, or malignant disorders
• patients suffering from degenerative soft tissue disorders
• patients receiving immunosuppressive drugs for more than 3 weeks or during a - 3-week perioperative time interval

Sponsors & Collaborators

• Johannes Mayr: lead

Related Publications (6)

• American College of Surgeons. Surgical Patient Education. http://www.facs.org/patient education.

  BACKGROUND

• Kapur P, Caty MG, Glick PL. Pediatric hernias and hydroceles. Pediatr Clin North Am. 1998 Aug;45(4):773-89. doi: 10.1016/s0031-3955(05)70044-4.

  PMID: 9728185 BACKGROUND

• Kiesewetter WB, Oh KS. Unilateral inguinal hernias in children: What about the opposite side? Arch Surg. 1980 Dec;115(12):1443-5. doi: 10.1001/archsurg.1980.01380120019005.

  PMID: 7447688 BACKGROUND

• Ramshaw BJ, Esartia P, Schwab J, Mason EM, Wilson RA, Duncan TD, Miller J, Lucas GW, Promes J. Comparison of laparoscopic and open ventral herniorrhaphy. Am Surg. 1999 Sep;65(9):827-31; discussion 831-2.

  PMID: 10484084 BACKGROUND

• Tsai YC, Wu CC, Yang SS. Minilaparoscopic herniorrhaphy with hernia sac transection in children and young adults: a preliminary report. Surg Endosc. 2007 Sep;21(9):1623-5. doi: 10.1007/s00464-007-9207-y. Epub 2007 Mar 13.

  PMID: 17353989 BACKGROUND

• Tsai YC, Wu CC, Yang SS. Is local anesthesia or oral analgesics necessary after mini-laparoscopic functional surgery in children and young adults?: A prospective randomized trial. Surg Laparosc Endosc Percutan Tech. 2008 Aug;18(4):344-7. doi: 10.1097/SLE.0b013e318172ab33.

  PMID: 18716531 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sucharitha Geiger

  University Childrens Hospital Basel

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2014
• First Posted: December 8, 2014
• Study Start: March 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: May 26, 2017
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share