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| ID | Type | Description | Link |
|---|---|---|---|
| H-2-2010129 | Other Identifier | The Danish National Committee on Biomedical Research Ethics |
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| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
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The purpose of this study is to compare sharp and blunt fascial entry during caesarean section on the same patient. The study is performed on woman having cesarean section for the first time and who have not previously had lower abdominal surgery done. The following parameters are registered:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right sharp, left blunt | Experimental | Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline. |
|
| Right blunt, left sharp | Experimental | Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blunt right, sharp left | Procedure | Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preferred side of the scar evaluated by the patient 3 months postoperatively | The overall preference of scar side - left, right or no difference - taking the entire postoperative 3 months into account as evaluated by the patient. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in pain between the two sides of the scar | Difference in painscore between the two ends of the scar on the 1st, 2nd and 7th postoperative day. Pain is registered by a score on a vas-scale from 0-10. | 1, 3 and 7 days postoperatively |
| The difference in pain between the two sides of the scar |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Jørgen Secher, Professor, M.D. | Dep. Gynaecology and Obstetrics, Hvidovre University Hospital | Study Chair |
| Anna Aabakke, M.D. | Dep. Gynaecology and Obstetrics, Holbaek Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynaechology and Obstetrics, Holbaek Hospital | Holbæk | 4300 | Denmark | |||
| Department of Gynaecology and obstetrics, Hvidovre University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14674981 | Background | Nikolajsen L, Sorensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6. doi: 10.1111/j.1399-6576.2004.00271.x. | |
| 14520211 | Background | Jenkins TR. It's time to challenge surgical dogma with evidence-based data. Am J Obstet Gynecol. 2003 Aug;189(2):423-7. doi: 10.1067/s0002-9378(03)00587-8. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Blunt left, sharp right | Procedure | Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline. |
|
Description: Difference in painscore between the two ends of the scar one and three months postoperatively. Pain is registered by a score on a vas-scale from 0-10. |
| 1 and 3 months postoperatively |
| Pain on the two sides of the scar | Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1, 3 and 7 days postoperatively. | 1, 3 and 7 days postoperatively |
| Pain in the two sides of the scar | Pain in the two sides of the scar is registered by a score on a vas-scale from 0-10 1 and 3 months postoperatively. | 1 and 3 months postoperatively |
| Infection | The rate of postoperative infection and what side of the scar - right or left -that is infected. | 7 days |
| Infection | The rate of postoperative infection and what side of the scar - right or left -that is infected. | 1 and 3 months postoperatively |
| Hvidovre |
| 2650 |
| Denmark |
| 20840692 | Background | CAESAR study collaborative group. Caesarean section surgical techniques: a randomised factorial trial (CAESAR). BJOG. 2010 Oct;117(11):1366-76. doi: 10.1111/j.1471-0528.2010.02686.x. |
| 18336721 | Background | CORONIS Trial Collaborative Group. The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial. BMC Pregnancy Childbirth. 2007 Oct 22;7:24. doi: 10.1186/1471-2393-7-24. |
| 16260200 | Background | Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063. |
| 17253508 | Background | Mathai M, Hofmeyr GJ. Abdominal surgical incisions for caesarean section. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD004453. doi: 10.1002/14651858.CD004453.pub2. |
| 12421172 | Background | Franchi M, Ghezzi F, Raio L, Di Naro E, Miglierina M, Agosti M, Bolis P. Joel-Cohen or Pfannenstiel incision at cesarean delivery: does it make a difference? Acta Obstet Gynecol Scand. 2002 Nov;81(11):1040-6. doi: 10.1034/j.1600-0412.2002.811108.x. |
| 10422908 | Background | Holmgren G, Sjoholm L, Stark M. The Misgav Ladach method for cesarean section: method description. Acta Obstet Gynecol Scand. 1999 Aug;78(7):615-21. |
| 8194647 | Background | Stark M, Finkel AR. Comparison between the Joel-Cohen and Pfannenstiel incisions in cesarean section. Eur J Obstet Gynecol Reprod Biol. 1994 Feb;53(2):121-2. doi: 10.1016/0028-2243(94)90218-6. |
| 12113971 | Background | Mathai M, Ambersheth S, George A. Comparison of two transverse abdominal incisions for cesarean delivery. Int J Gynaecol Obstet. 2002 Jul;78(1):47-9. doi: 10.1016/s0020-7292(02)00061-9. No abstract available. |
| Background | Bolla D, Schöning A, Drack G, Hornung R. Technical aspects of the cesarean section. Gynecol Surg 2010;7:127-32. |
| 24275233 | Derived | Aabakke AJ, Hare KJ, Krebs L, Secher NJ. Sharp compared with blunt fascial incision at cesarean delivery: a randomized controlled trial with each case as her own control. Eur J Obstet Gynecol Reprod Biol. 2014 Jan;172:40-5. doi: 10.1016/j.ejogrb.2013.10.029. Epub 2013 Nov 5. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014946 | Wound Infection |
| D007239 | Infections |