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Recruiting problems
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| Name | Class |
|---|---|
| Clinical Trial Unit, University Hospital Basel, Switzerland | OTHER |
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This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind the rectus muscle after small incision close to the belly button.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intraperitoneal onlay mesh repair | Active Comparator |
| |
| sublay mesh repair | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraperitoneal onlay mesh repair | Procedure | The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button. |
| Measure | Description | Time Frame |
|---|---|---|
| early wound complications |
| 30 days after operation |
| late wound complications |
| 1 year after operation |
| Measure | Description | Time Frame |
|---|---|---|
| complication rate perioperative |
| intraoperative complications will be recorded immediately after finishing the operation |
| duration of operation | measured in minutes according to operations protocol (duration cut - suture) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Oertli, Professor | Departement of General Surgery, University Hospital Basel, Switzerland | Study Chair |
| Oleg Heizmann, MD | Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany | Study Director |
| Daniel Matz, MD | Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH | Rotenburg (Wümme) | Lower Saxony | 27356 | Germany | ||
| University Hospital Basel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18924044 | Background | Benhidjeb T, Benecke C, Strik MW. [Incisional hernia repair: sublay or intraperitoneal onlay mesh (IPOM)?]. Zentralbl Chir. 2008 Sep;133(5):458-63. doi: 10.1055/s-2008-1076954. Epub 2008 Oct 15. German. | |
| 14574545 | Background | Lau H, Patil NG. Umbilical hernia in adults. Surg Endosc. 2003 Dec;17(12):2016-20. doi: 10.1007/s00464-003-9027-7. Epub 2003 Oct 28. |
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| ID | Term |
|---|---|
| D006554 | Hernia, Umbilical |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006555 | Hernia, Ventral |
| D046449 | Hernia, Abdominal |
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|
| sublay mesh repair | Procedure | The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button. |
|
| the duration will be recorded immediately after finishing the operation |
| hospital stay | measured in days | will be measured after discharge of the patient |
| umbilical hernia recurrence rate | the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan | 30 days |
| umbilical hernia recurrence rate | the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan | 1 year |
| umbilical hernia recurrence rate | the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan | 3 years |
| umbilical hernia recurrence rate | the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan | 5 years |
| navel site seroma | the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm)) | discharge day |
| navel site seroma | the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm)) | after 30 days |
| navel site seroma | the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm)) | after 1 year |
| complication rate postoperative |
| 30 day |
| complication rate postoperative |
| 1 year |
| complication rate postoperative |
| 3 years |
| complication rate postoperative |
| 5 years |
| pain score (Visual Analog Scale - VAS) | will be measured by the nurse according to Visual Analog Scale | 24h post operative |
| pain score (Visual Analog Scale - VAS) | will be measured by the nurse according to Visual Analog Scale | 48h post operative |
| pain score (Visual Analog Scale - VAS) | will be measured by the nurse according to Visual Analog Scale | immediately before discharge |
| Quality of life (SF-36) | patients will be asked to fulfill validated SF-36 questionnaire | 1 day pre-operative |
| Quality of life (SF-36) | patients will be asked to fulfill validated SF-36 questionnaire | 30 days postoperatively |
| Quality of life (SF-36) | patients will be asked to fulfill validated SF-36 questionnaire | 1 year postoperatively |
| Basel |
| 4031 |
| Switzerland |
| Luzerner Kantonsspital | Lucerne | 6000 | Switzerland |
| 17861015 | Background | Mayo WJ. VI. An Operation for the Radical Cure of Umbilical Hernia. Ann Surg. 1901 Aug;34(2):276-80. doi: 10.1097/00000658-190107000-00021. No abstract available. |
| 10933738 | Background | Luijendijk RW, Hop WC, van den Tol MP, de Lange DC, Braaksma MM, IJzermans JN, Boelhouwer RU, de Vries BC, Salu MK, Wereldsma JC, Bruijninckx CM, Jeekel J. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000 Aug 10;343(6):392-8. doi: 10.1056/NEJM200008103430603. |
| 19124962 | Background | Venclauskas L, Silanskaite J, Kiudelis M. Umbilical hernia: factors indicative of recurrence. Medicina (Kaunas). 2008;44(11):855-9. |
| 19015918 | Background | Hilling DE, Koppert LB, Keijzer R, Stassen LP, Oei IH. Laparoscopic correction of umbilical hernias using a transabdominal preperitoneal approach: results of a pilot study. Surg Endosc. 2009 Aug;23(8):1740-4. doi: 10.1007/s00464-008-0177-5. Epub 2008 Nov 18. |
| 19591158 | Background | Forbes SS, Eskicioglu C, McLeod RS, Okrainec A. Meta-analysis of randomized controlled trials comparing open and laparoscopic ventral and incisional hernia repair with mesh. Br J Surg. 2009 Aug;96(8):851-8. doi: 10.1002/bjs.6668. |
| 8975342 | Background | Bullinger M. [Assessment of health related quality of life with the SF-36 Health Survey]. Rehabilitation (Stuttg). 1996 Aug;35(3):XVII-XXVII; quiz XXVII-XXIX. German. |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |