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Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of postoperative pain.
The study hypothesis is that there is no difference in postoperative pain between different methods to fix the mesh in laparoscopic incisional / ventral hernia repair.
One of the complications in laparoscopic incisional / ventral hernia repair is postoperative pain. Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of this postoperative pain. Fixation of the mesh might also influence other outcome parameters such as return to preoperative activities, costs and recurrence rate.
The study hypothesis is that there is no difference in postoperative pain when comparing three commonly used mesh fixation techniques in laparoscopic incisional / ventral hernia repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 | Active Comparator | fixation of mesh with a single crown of tacks and absorbable sutures |
|
| 1 | Active Comparator | fixation of mesh with a double crown of tacks and no sutures |
|
| 2 | Active Comparator | fixation of mesh with a single crown of tacks and non-absorbable sutures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic correction of hernia with mesh | Procedure | Correction of hernia with mesh and fixation of mesh using one of the arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of postoperative pain | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | one year | |
| Overall satisfaction | one year | |
| Postoperative stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eelco B Wassenaar, MD | Ziekenhuisgroep Twente | Principal Investigator |
| Srjdan Rakic, MD, PhD | Ziekenhuisgroep Twente | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuisgroep Twente | Almelo | 7600 SZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12361426 | Background | Goodney PP, Birkmeyer CM, Birkmeyer JD. Short-term outcomes of laparoscopic and open ventral hernia repair: a meta-analysis. Arch Surg. 2002 Oct;137(10):1161-5. doi: 10.1001/archsurg.137.10.1161. | |
| 10790548 | Background | DeMaria EJ, Moss JM, Sugerman HJ. Laparoscopic intraperitoneal polytetrafluoroethylene (PTFE) prosthetic patch repair of ventral hernia. Prospective comparison to open prefascial polypropylene mesh repair. Surg Endosc. 2000 Apr;14(4):326-9. doi: 10.1007/s004640020013. |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| D006555 | Hernia, Ventral |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D009074 | Melanocyte-Stimulating Hormones |
| C025539 | Lavsan |
| D011098 | Polyglactin 910 |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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|
| one month |
| Per- and postoperative morbidity | one month |
| Recurrence | Three years |
| 15235939 | Background | LeBlanc KA. Laparoscopic incisional and ventral hernia repair: complications-how to avoid and handle. Hernia. 2004 Dec;8(4):323-31. doi: 10.1007/s10029-004-0250-5. |
| 14501505 | Background | Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab. |
| 20033726 | Derived | Wassenaar E, Schoenmaeckers E, Raymakers J, van der Palen J, Rakic S. Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques. Surg Endosc. 2010 Jun;24(6):1296-302. doi: 10.1007/s00464-009-0763-1. Epub 2009 Dec 24. |
| D010335 | Pathologic Processes |
| D046449 | Hernia, Abdominal |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D011091 | Polyesters |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |