Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

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

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

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 575

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China, 510317
      • The Second People's Hospital of Guangdong Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence rate	the inguinal hernia recurrence after operation	five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of days to recovery normal activity	the days to recovery normal activity after surgery	one month
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

Collaborators and Investigators

• Sponsor: The Second People's Hospital of GuangDong Province
• Investigators: Study Chair: kaiyun chen, MD, The Second People's Hospital of Guangdong Province

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (Estimate): June 21, 2011

Study Record Updates

• Last Update Posted (Estimate): June 22, 2011
• Last Update Submitted That Met QC Criteria: June 21, 2011
• Last Verified: January 1, 2000

More Information

Terms related to this study

• Keywords: Pediatric; Recurrence; Inguinal hernia; Laparoscope; Lateral us ligament; unilateral inguinal hernia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: ABT-1233-RV