Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

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StatusLengkap

Sponsor

The Second People's Hospital of GuangDong Province

UJI KLINIS: NCT01377181

BioSeek: nct01377181

Kata kunci

Abstrak

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

Deskripsi

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.

tanggal

Terakhir Diverifikasi:	12/31/1999
Pertama Dikirim:	09/01/2010
Perkiraan Pendaftaran Telah Dikirim:	06/19/2011
Pertama Diposting:	06/20/2011
Pembaruan Terakhir Dikirim:	06/20/2011
Pembaruan Terakhir Diposting:	06/21/2011
Tanggal Mulai Studi Sebenarnya:	12/31/1999
Perkiraan Tanggal Penyelesaian Utama:	11/30/2010
Perkiraan Tanggal Penyelesaian Studi:	11/30/2010

Kondisi atau penyakit

Inguinal Hernia

Tahap

Kelompok Lengan

Lengan	Intervensi / pengobatan
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

Kriteria kelayakan

Usia yang Layak untuk Belajar	2 Years Untuk 2 Years
Jenis Kelamin yang Layak untuk Belajar	All
Metode pengambilan sampel	Probability Sample
Menerima Relawan Sehat	Iya
Kriteria	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

Hasil

Ukuran Hasil Utama

1. recurrence rate [five years]

the inguinal hernia recurrence after operation

Ukuran Hasil Sekunder

1. number of days to recovery normal activity [one month]

the days to recovery normal activity after surgery

2. degree of postoperative pain [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)