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| ID | Type | Description | Link |
|---|---|---|---|
| T 1040L0007 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OH | Active Comparator | Inguinal hernia operated using a classic open herniotomy(OH) |
|
| LH | Active Comparator | Laparoscopic herniorraphy (LH) for inguinal hernia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hernia repair | Procedure | Hernia repair laparoscopically (LH) or by open operation (OH) |
|
| Measure | Description | Time Frame |
|---|---|---|
| recovery after inguinal hernia surgery = time to restore normal activities after surgery | one week |
| Measure | Description | Time Frame |
|---|---|---|
| degree of postoperative pain | 3 days | |
| duration of surgery and hospital stay | 1 day | |
| long term surgical result |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antti I Koivusalo, MDPhD | Hospital for Children and Adolescents,Helsinki,Finland | Principal Investigator |
| Mikko P Pakarinen, MD PhD | Hospital for Children and Adolescents,Helsinki,Finland | Principal Investigator |
| Risto J Rintala, Professor | Hospital for Children and Adolescents,Helsinki,Finland | Principal Investigator |
| Christer Holmberg, Professor | Hospital for Children and Adolescents,Helsinki,Finland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Children and Adolescents | Helsinki | 000290 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17235721 | Background | 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. | |
| 16862612 | Background | Eklund 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. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059685 | Herniorrhaphy |
| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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| 2 years |
| 16769338 | Background | Schier 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. |
| 19117900 | Derived | Koivusalo 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. |