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| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
| University Hospital, Gentofte, Copenhagen | OTHER |
| Frederikshavn Hospital | UNKNOWN |
| Nyborg Hospital |
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The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.
Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no suture | Active Comparator | self-adhesive mesh, i.e. no suture for mesh fixation |
|
| Suture | Experimental | Suture for mesh fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suture | Procedure | suture for mesh fixation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain, Numbness and Discomfort in the Groin | The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit. | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia. | 12 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Rosenberg, MD, DSc | Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | Copenhaven | 2400 | Denmark | ||
| Frederikshavn Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23203909 | Result | Jorgensen LN, Sommer T, Assaadzadeh S, Strand L, Dorfelt A, Hensler M, Rosenberg J; Danish Multicentre DANGRIP Study Group. Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair. Br J Surg. 2013 Mar;100(4):474-81. doi: 10.1002/bjs.9006. Epub 2012 Nov 30. | |
| 20433715 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | no Suture | self-adhesive mesh, i.e. no suture for mesh fixation no suture: no suture for mesh fixation, because we use a self-adhesive mesh |
| FG001 | Suture | Suture for mesh fixation suture: suture for mesh fixation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | no Suture | self-adhesive mesh, i.e. no suture for mesh fixation no suture: no suture for mesh fixation, because we use a self-adhesive mesh |
| BG001 | Suture | Suture for mesh fixation suture: suture for mesh fixation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain, Numbness and Discomfort in the Groin | The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit. | Posted | Number | participants | 12 months after surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | no Suture | self-adhesive mesh, i.e. no suture for mesh fixation no suture: no suture for mesh fixation, because we use a self-adhesive mesh |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacob Rosenberg | Herlev Hospital, dept. of Surgery | +45 26237323 | jacob.rosenberg@regionh.dk |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D010146 | Pain |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| D011126 | Polypropylenes |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D011090 | Polyenes |
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| UNKNOWN |
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| no suture | Procedure | no suture for mesh fixation, because we use a self-adhesive mesh |
|
|
| Frederikshavn |
| Frederikshavn |
| 9900 |
| Denmark |
| Gentofte Hospital | Gentofte Municipality | Hellerup | 2900 | Denmark |
| Randers Hospital | Randers | Randers | 8930 | Denmark |
| Nyborg Hospital | Nyborg | Svendborg | 5700 | Denmark |
| Rosenberg J, Henriksen NA, Jorgensen LN. Multicenter data acquisition made easy. Trials. 2010 Apr 30;11:49. doi: 10.1186/1745-6215-11-49. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Recurrence | recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia. | Posted | Number | participants | 12 months after surgery |
|
|
|
| 0 |
| 163 |
| 0 |
| 163 |
| EG001 | Suture | Suture for mesh fixation suture: suture for mesh fixation | 0 | 171 | 0 | 171 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000475 |
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |