Inguinal HerniaNCT01377181
Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children
An observational study of Inguinal Hernia, run by The Second People's Hospital of GuangDong Province at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- How many people
- 575 participants
- Where
- 1 siteChina
- Study dates
- Jan 2000to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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
Who cannot join
- the bilateral hernia
- the recurrence hernia
Trial locations and contacts
1 site in 1 country.
China1 site
The Second People's Hospital of GuangDong Province
Guangzhou, Guangdong, 510317
About this study
Official title: 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
Read the 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.
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal hernia, Laparoscope, Lateral us ligament, Recurrence, Pediatric, unilateral inguinal hernia
- Medical subject headings
- Hernia, Inguinal, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
the inguinal hernia recurrence after operation
Measured: five years
Secondary outcomes (2)
number of days to recovery normal activity
the days to recovery normal activity after surgery
Measured: 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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJan 2000
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second People's Hospital of GuangDong Province
- Sponsor type
- University, hospital or other
- Investigators
- kaiyun chen, MD, Study chair, The Second People's Hospital of GuangDong Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377181
- Sponsor's protocol ID
- ABT-1233-RV
- Status last verified
- Jan 2000
- First submitted
- 2 Sep 2010
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children
- ClinicalTrials.gov ID
- NCT01377181
- Acronym / sponsor ID
- ABT-1233-RV
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal hernia, Laparoscope, Lateral us ligament, Recurrence, Pediatric, unilateral inguinal hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- The Second People's Hospital of GuangDong ProvinceUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- the bilateral hernia
- the recurrence hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
recurrence rate
Time frame: five years
the inguinal hernia recurrence after operation
2 secondary outcomes
number of days to recovery normal activity
Time frame: one month
degree of postoperative pain
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kaiyun chen, MD study chair
The Second People's Hospital of GuangDong Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by The Second People's Hospital of GuangDong Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011.