a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

Complications of Surgical and Medical Care: General Terms Clinical Trial

Official title:

Phase 3 Study of a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380067
• Other study ID #: 8808
• Status: Completed
• Phase: N/A
• First received: June 17, 2011
• Last updated: June 22, 2011
• Start date: January 2000
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• 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

laparoscopic hernia sac high-ligation

• has a high recurrence rate laparoscopic hernia sac high-ligation and the lateral umbilicus ligament covering the hernia opening

• The investigators developed a method of laparoscopic hernia repair by applying a new concept in hernia repair. The hernia opening was tightened, and hernia opening region repaired with a lateral umbilicus ligament in a tension-free manner. This method combines the advantages of a secure repair achieved by the open method with the minimal invasiveness of the laparoscopic method. 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: 486
• Est. completion date: December 2010
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• unilateral inguinal hernia age between 2 and 17 years the absence of a history of abdominal or inguinal operations. Of the male patients, only those with completely descended testes were included.

Exclusion Criteria:

• the bilateral cases

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complications of Surgical and Medical Care: General Terms
• Hernia, Inguinal

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate	The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery.	five years	Yes
Secondary	degree of postoperative pain	The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery.	one year	Yes
Secondary	patient satisfaction.	The patient satisfaction was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3). The long axis of the testes was measured.	one year	Yes