Sharp Versus Blunt Fascial Incision at Caesarean Section
NCT ID: NCT01297725
Last Updated: 2011-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2011-01-31
2011-10-31
Brief Summary
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1. The preferred side evaluated by the patient 3 months postoperatively.
2. The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and 1 and 3 months postoperatively.
3. The rate and side of infection.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Right sharp, left blunt
Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline.
Blunt left, sharp right
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
Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline.
Blunt right, sharp left
Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline.
Interventions
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Blunt right, sharp left
Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline.
Blunt left, sharp right
Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline.
Eligibility Criteria
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Inclusion Criteria
* Woman, who have had no previous lower abdominal surgery
* Woman who speak and understand Danish
* Woman who can give informed consent
Exclusion Criteria
* Infection
* Regular treatment with immunosuppressives
* Alcohol or drug abuse
* Age under 18 years old
* Chronic pain disease eg. fibromyalgia, rheumatoid arthritis
* BMI over 35
18 Years
FEMALE
Yes
Sponsors
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Hvidovre University Hospital
OTHER
Holbaek Sygehus
OTHER
Responsible Party
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Anna Aabakke
Anna Aabakke
Principal Investigators
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Niels Jørgen Secher, Professor, M.D.
Role: STUDY_CHAIR
Dep. Gynaecology and Obstetrics, Hvidovre University Hospital
Anna Aabakke, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dep. Gynaecology and Obstetrics, Holbaek Hospital
Locations
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Department of Gynaechology and Obstetrics, Holbaek Hospital
Holbæk, , Denmark
Department of Gynaecology and obstetrics, Hvidovre University Hospital
Hvidovre, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Bolla D, Schöning A, Drack G, Hornung R. Technical aspects of the cesarean section. Gynecol Surg 2010;7:127-32.
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.
Other Identifiers
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H-2-2010129
Identifier Type: OTHER
Identifier Source: secondary_id
Fascia Study
Identifier Type: -
Identifier Source: org_study_id