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Outcome of Laparoscopic Inguinal Herniorraphy in Children

NCT ID: NCT02310958

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2017-05-26

Brief Summary

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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.

Detailed Description

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Hernias of the abdominal wall occur if intra-abdominal tissue or peritoneum bulges through the abdominal wall. The most frequent locations of abdominal wall hernia are the inguinal region close to the groin, the umbilicus, and scars. Congenital inguinal hernias occur more frequently in the inguinal region if the vaginal process is not closed adequately at birth. Surgical procedures for correction of inguinal hernias are frequently carried out in children. Laparoscopic procedures to correct inguinal hernias in children are gaining more acceptance. The laparoscopic closure of hernias in children is considered effective and safe and represents an accepted alternative to the open surgical hernia repair. When compared to open surgical hernia repair in children, laparoscopic hernia repair causes smaller scars, allows for a faster postoperative recovery of children, requires less pain medication, and allows for an inspection of the contralateral side, thus facilitating simultaneous hernia repair in the same operation.

We aim to investigate the short-term results of laparoscopic inguinal hernia repair in children. The main outcome parameter of this single-center study is hernia recurrence or the occurrence of contralateral metachronous hernia. Secondary outcome measures are postoperative complications such as infections of the wound regions, the time between operation and discharge from hospital, and postoperative pain medication requirements. We chose a 4-year time interval for inclusion of patients. Data are retrieved from hospital records in a retrospective evaluation. In addition, a structured questionnaire sent to the families of children will document postoperative complaints and complications from 3 months after the operation onwards. Families not responding to the questionnaire will be offered a structured telephone interview.

Conditions

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Hernia, Inguinal

Keywords

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Lapraroscopic surgical procedure infant complications inguinal hernia hernia recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with inguinal hernia

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

Laparoscopic surgical hernia repair

Intervention Type PROCEDURE

Laparoscopic surgical hernia repair in children

Interventions

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Laparoscopic surgical hernia repair

Laparoscopic surgical hernia repair in children

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Day

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Mayr

OTHER

Sponsor Role lead

Responsible Party

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Johannes Mayr

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sucharitha Geiger

Role: STUDY_CHAIR

University Childrens Hospital Basel

References

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 9728185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7447688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10484084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17353989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18716531 (View on PubMed)

Other Identifiers

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EKNZ2014-247

Identifier Type: -

Identifier Source: org_study_id