Clinical trial NCT01297725: Sharp Versus Blunt Fascial Incision at Caesarean Section
Official title: Sharp Versus Blunt Fascial Incision at Caesarean Section: A Prospective Randomized Double-blinded Case-Control Study With the Case as it's Own Control.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Cesarean section
Cesarean section[*methods]
Fascia [*surgery]
Randomized Controlled Trial
Abdominal Wall [*surgery]
Pain, postoperative
Surgical wound infection
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2011-02-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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:

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.


Eligibility criteria: Inclusion Criteria:

* Woman having caesarean section for the first time
* Woman, who have had no previous lower abdominal surgery
* Woman who speak and understand Danish
* Woman who can give informed consent

Exclusion Criteria:

* Diabetes Mellitus (This does not include gestational diabetes)
* Infection
* Regular treatment with immunosuppressives
* Alcohol or drug abuse
* Age under 18 years old
* Chronic pain disease eg. fibromyalgia, rheumatoid arthritis
* BMI over 35

Primary outcomes:
measure: Preferred side of the scar evaluated by the patient 3 months postoperatively
timeFrame: 3 months
Secondary outcomes:
measure: The difference in pain between the two sides of the scar
timeFrame: 1, 3 and 7 days postoperatively
measure: The difference in pain between the two sides of the scar
timeFrame: 1 and 3 months postoperatively
measure: Pain on the two sides of the scar
timeFrame: 1, 3 and 7 days postoperatively
measure: Pain in the two sides of the scar
timeFrame: 1 and 3 months postoperatively
measure: Infection
timeFrame: 7 days
measure: Infection
timeFrame: 1 and 3 months postoperatively
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Department of Gynaechology and Obstetrics, Holbaek Hospital
city: Hvidovre
country: Denmark
facility: Department of Gynaecology and obstetrics, Hvidovre University Hospital
Study officials:
affiliation: Dep. Gynaecology and Obstetrics, Hvidovre University Hospital
name: Niels Jørgen Secher, Professor, M.D.
role: STUDY_CHAIR
affiliation: Dep. Gynaecology and Obstetrics, Holbaek Hospital
name: Anna Aabakke, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bolla D, Schöning A, Drack G, Hornung R. Technical aspects of the cesarean section. Gynecol Surg 2010;7:127-32.
citation: 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.