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Completed

NCT Number: NCT01377181

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

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Key information

Conditions

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

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second People's Hospital of GuangDong Province

Guangzhou, Guangdong, 510317, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. recurrence rate

    Time frame: five years

    the inguinal hernia recurrence after operation

Secondary outcomes

  1. number of days to recovery normal activity

    Time frame: one month

    the days to recovery normal activity after surgery

  2. degree of postoperative pain

    Time frame: one year

    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)

Sponsors and collaborators

Lead sponsor

The Second People's Hospital of GuangDong Province

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2010
Study completion
2010
First posted
Jun 21, 2011
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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