Laparoscopic Hernia Repair With Lateral Umbilicus Ligamen... | NCT01377181

Studies
Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

NCT01377181

Sponsor

The Second People's Hospital of GuangDong Province

Status

Completed

Last Update Posted

Jun 22, 2011Estimated

Enrollment

575Actual

Phase

Not provided

Conditions

Inguinal Hernia

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2000

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 2, 2010

First Submission Date that Met QC Criteria

Jun 20, 2011

First Posted Date

Jun 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2011

Last Update Posted Date

Jun 22, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

The Second People's Hospital of GuangDong ProvinceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

575Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
kaiyun chen, MD	The Second People's Hospital of GuangDong Province	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second People's Hospital of GuangDong Province		Guangzhou	Guangdong	510317	China

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal
D012008	Recurrence

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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