Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

NCT01377181 | Completed DMC

• 1 other identifier: ABT-1233-RV
• Study Type: observational
• Target: 575
• Locations: 1 country
• Sites: 1

Brief Summary

The role of laparoscopic surgery in pediatric inguinal hernia repair is clear. Laparoscopic hernia repair is especially advantageous for bilateral diseases and minimally invasive technique in children because it avoids vas injury. However, the problem of recurrent rate has not been resolved. The aim of this study was to refine the current criteria used the lateral umbilicus ligament covering the internal hernia opening region, and eliminated recurrence in laparoscopic inguinal hernia (LIH) repair in children. The investigators hypothesized that the lateral umbilicus ligament covering the internal hernia opening region after the laparoscopic purse-string knot would result in lower recurrence and the same operation relative complication

Conditions

Inguinal Hernia

Keywords

Inguinal hernia; Laparoscope; Lateral us ligament; Recurrence; Pediatric; unilateral inguinal hernia

Outcome Measures

Primary Outcomes (1)

• recurrence rate

  the inguinal hernia recurrence after operation

  five years

Secondary Outcomes (2)

• number of days to recovery normal activity

  one month

• degree of postoperative pain

  one year

Study Arms (2)

group A

the patients were accepted laparoscopic purse-string knot closing the internal hernia opening only

group B

the patients were accepted the lateral umbilicus ligament covering the internal hernia opening region after the laparoscopic purse-string knot

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All patients between 2 years and 17 years of age undergoing laparoscopic inguinal hernia repair at our institution by a single surgeon from January, 2000 to August, 2005 were prospectively followed for outcome.

You may qualify if:

• unilateral inguinal hernia
• age between 2 years and 17 years
• no history of abdominal or inguinal operations
• the age range was based on the day surgery criteria of our hospital
• of male patients, only those with completely descended testes were included

You may not qualify if:

• the bilateral hernia
• the recurrence hernia

Sponsors & Collaborators

• The Second People's Hospital of GuangDong Province: lead

Study Sites (1)

The Second People's Hospital of GuangDong Province

Guangzhou, Guangdong, 510317, China

Location

MeSH Terms

Conditions

Hernia, Inguinal; Recurrence

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• kaiyun chen, MD

  The Second People's Hospital of GuangDong Province

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: June 21, 2011
• Study Start: January 1, 2000
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 22, 2011

Record last verified: 2000-01

Locations

CN (1)