Inguinal HerniaNCT00597194
Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
A study testing Hernia repair in people with Inguinal Hernia, run by Hospital for Children and Adolescents, Finland at 1 site in Finland.
Trial summary
We compare laparoscopic and classic open operation for inguinal hernia in children. Attention is focused on the recovery, surgical result and the duration of the operation and hospital stay. Read more about this study
- Who is it for?
- Ages 4 months to 16 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2002to Jan 2007
- Phase
- Interventional
- 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 4 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- unilateral inguinal hernia
- age age > 4 months, <16 years
- fully descended testes
- study consent signed
Who cannot join
- previous abdominal or inguinal surgery
- testes not fully descended
- not healthy enough for day surgery
- age < 4months or >16 years
- study consent not signed
Trial locations and contacts
1 site in 1 country.
About this study
We compare laparoscopic and classic open operation for inguinal hernia in children. Attention is focused on the recovery, surgical result and the duration of the operation and hospital stay.
Read the detailed description
Background and objective : In adults the advantages laparoscopic inguinal hernia are less pain, shorter recovery, shorter sick leave and better cosmetic result. It is not known whether laparoscopic hernia repair produces similar results in children.The objective is to compare the duration of recovery, postoperative pain and long-term surgical results between day case laparoscopic and open inguinal hernia repair in children.
Key inclusion criteria: Children included in the study must be aged four months to sixteen years of age and not have undergone any previous surgery. Of male patients those with completely descended testes are accepted.
Study type: The study is randomized, single-blinded prospective comparison between laparoscopic and open day case inguinal hernia repair in children.
Target sample size: For the assumption that there is a difference of one day in time to restore normal activities after laparoscopic and open hernia repair, target sample size of 100 patients in the laparoscopic and 100 in open repair arm should reach 90% power with p < 0.05.
Recruitment status : From 10/ 2002 to 1/2007 89 patients (laparoscopic repair LH 47, open repair OH 42) are recruited. Primary outcome: The time to restore normal activity after surgery . Secondary Outcomes : The degree of postoperative pain, the duration of the operation, sick leave of parents, surgical result 6 months and 2 years after the repair.
- Conditions
- Inguinal Hernia
- Being tested
- Hernia repair
- Keywords
- inguinal hernia, laparoscopic repair, open repair, randomized
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hernia repairProcedure or surgery
Hernia repair laparoscopically (LH) or by open operation (OH)
| Study group | Role | What they receive |
|---|---|---|
| OH | Active comparator | Inguinal hernia operated using a classic open herniotomy(OH) Receives: Procedure: Hernia repair |
| LH | Active comparator | Laparoscopic herniorraphy (LH) for inguinal hernia Receives: Procedure: Hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery after inguinal hernia surgery = time to restore normal activities after surgery
Measured: one week
Secondary outcomes (3)
degree of postoperative pain
Measured: 3 days
duration of surgery and hospital stay
Measured: 1 day
long term surgical result
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startOct 2002
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Children and Adolescents, Finland
- Sponsor type
- University, hospital or other
- Investigators
- Antti I Koivusalo, MDPhD, Principal investigator, Hospital for Children and Adolescents,Helsinki,FinlandMikko P Pakarinen, MD PhD, Principal investigator, Hospital for Children and Adolescents,Helsinki,FinlandRisto J Rintala, Professor, Principal investigator, Hospital for Children and Adolescents,Helsinki,FinlandChrister Holmberg, Professor, Study director, Hospital for Children and Adolescents,Helsinki,Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597194
- Sponsor's protocol ID
- 216L2002
- Other IDs
- T 1040L0007
- Status last verified
- Dec 2007
- First submitted
- 8 Jan 2008
- Last updated
- 17 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Butler RE, Burke R, Schneider JJ, Brar H, Lucha PA Jr. The economic impact of laparoscopic inguinal hernia repair: results of a double-blinded, prospective, randomized trial. Surg Endosc. 2007 Mar;21(3):387-90. doi: 10.1007/s00464-006-9123-6. Epub 2007 Jan 19.
PubMed 17235721Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.
PubMed 16862612Schier F. Laparoscopic inguinal hernia repair-a prospective personal series of 542 children. J Pediatr Surg. 2006 Jun;41(6):1081-4. doi: 10.1016/j.jpedsurg.2006.02.028.
PubMed 16769338Koivusalo AI, Korpela R, Wirtavuori K, Piiparinen S, Rintala RJ, Pakarinen MP. A single-blinded, randomized comparison of laparoscopic versus open hernia repair in children. Pediatrics. 2009 Jan;123(1):332-7. doi: 10.1542/peds.2007-3752.
PubMed 19117900
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
- ClinicalTrials.gov ID
- NCT00597194
- Acronym / sponsor ID
- 216L2002
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, laparoscopic repair, open repair, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hospital for Children and Adolescents, FinlandUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 17 Jan 2008 (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.
We compare laparoscopic and classic open operation for inguinal hernia in children. Attention is focused on the recovery, surgical result and the duration of the operation and hospital stay.
Detailed description
Background and objective : In adults the advantages laparoscopic inguinal hernia are less pain, shorter recovery, shorter sick leave and better cosmetic result. It is not known whether laparoscopic hernia repair produces similar results in children.The objective is to compare the duration of recovery, postoperative pain and long-term surgical results between day case laparoscopic and open inguinal hernia repair in children.
Key inclusion criteria: Children included in the study must be aged four months to sixteen years of age and not have undergone any previous surgery. Of male patients those with completely descended testes are accepted.
Study type: The study is randomized, single-blinded prospective comparison between laparoscopic and open day case inguinal hernia repair in children.
Target sample size: For the assumption that there is a difference of one day in time to restore normal activities after laparoscopic and open hernia repair, target sample size of 100 patients in the laparoscopic and 100 in open repair arm should reach 90% power with p < 0.05.
Recruitment status : From 10/ 2002 to 1/2007 89 patients (laparoscopic repair LH 47, open repair OH 42) are recruited. Primary outcome: The time to restore normal activity after surgery . Secondary Outcomes : The degree of postoperative pain, the duration of the operation, sick leave of parents, surgical result 6 months and 2 years after the repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OH | Active comparator | Procedure: Hernia repairInguinal hernia operated using a classic open herniotomy(OH) |
| LH | Active comparator | Procedure: Hernia repairLaparoscopic herniorraphy (LH) for inguinal hernia |
Who may qualify
- Ages
- 4 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- unilateral inguinal hernia
- age age > 4 months, <16 years
- fully descended testes
- study consent signed
Key exclusion criteria (5 listed)
- previous abdominal or inguinal surgery
- testes not fully descended
- not healthy enough for day surgery
- age < 4months or >16 years
- study consent not signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hernia repairHernia repair laparoscopically (LH) or by open operation (OH) | Procedure or surgery | LH, OH |
Primary outcome
recovery after inguinal hernia surgery = time to restore normal activities after surgery
Time frame: one week
3 secondary outcomes
degree of postoperative pain
Time frame: 3 days
duration of surgery and hospital stay
Time frame: 1 day
long term surgical result
Time frame: 2 years
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 17 Jan 2008.
- Background: PubMed 17235721Butler RE, Burke R, Schneider JJ, Brar H, Lucha PA Jr. The economic impact of laparoscopic inguinal hernia repair: results of a double-blinded, prospective, randomized trial. Surg Endosc. 2007 Mar;21(3):387-90. doi: 10.1007/s00464-006-9123-6. Epub 2007 Jan 19.
- Background: PubMed 16862612Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.
- Background: PubMed 16769338Schier F. Laparoscopic inguinal hernia repair-a prospective personal series of 542 children. J Pediatr Surg. 2006 Jun;41(6):1081-4. doi: 10.1016/j.jpedsurg.2006.02.028.
- Derived from this study: PubMed 19117900Koivusalo AI, Korpela R, Wirtavuori K, Piiparinen S, Rintala RJ, Pakarinen MP. A single-blinded, randomized comparison of laparoscopic versus open hernia repair in children. Pediatrics. 2009 Jan;123(1):332-7. doi: 10.1542/peds.2007-3752.
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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.
Antti I Koivusalo, MDPhD principal investigator
Hospital for Children and Adolescents,Helsinki,Finland
Mikko P Pakarinen, MD PhD principal investigator
Hospital for Children and Adolescents,Helsinki,Finland
Risto J Rintala, Professor principal investigator
Hospital for Children and Adolescents,Helsinki,Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hernia repair in people with Inguinal Hernia, run by Hospital for Children and Adolescents, Finland at 1 site in Finland.
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 4 inclusion and 5 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 17 Jan 2008. 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 Finland. 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?
recovery after inguinal hernia surgery = time to restore normal activities after surgery (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00597194, which also lists 4 linked publications.
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 17 Jan 2008.