Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

Inguinal Hernia Clinical Trial

Official title:

Phase 3 Study of Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377181
• Other study ID #: ABT-1233-RV
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: June 21, 2011
• Start date: January 2000
• Est. completion date: December 2010

Study information

• Verified date: January 2000
• Source: The Second People's Hospital of GuangDong Province
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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

Description:

The primary outcome measure was the recurrence rate after surgery, and the secondary outcome measures included degree of postoperative pain, the amount of postoperative analgesia, procedural duration, number of days to recovery normal activity, surgical complications, cosmetic results, and patient satisfaction. The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery. The cosmetic result was scored (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3) by the patients or parents, the attending nurse, and the surgeon (maximum points = 9). The patient satisfaction was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3). The long axis of the testes was measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 575
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• the bilateral hernia

• the recurrence hernia

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
China	The Second People's Hospital of GuangDong Province	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Second People's Hospital of GuangDong Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate	the inguinal hernia recurrence after operation	five years	Yes
Secondary	number of days to recovery normal activity	the days to recovery normal activity after surgery	one month	Yes
Secondary	degree of postoperative pain	postoperative pain was recorded on a modified objective pain scale (OPS) from 0 to 9.9. The next morning following discharge, a nurse specialist blinded to the operative approach phoned the families and recorded the level of pain on a scale from 0 to 3 (no pain = 0, mild pain = 1, moderate pain = 2, severe pain = 3)	one year	Yes