Sharp Versus Blunt Fascial Incision at Caesarean Section

Cesarean Section Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297725
• Other study ID #: Fascia Study
• Secondary ID: H-2-2010129
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: October 18, 2011
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Danish Data Protection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Denmark	Department of Gynaechology and Obstetrics, Holbaek Hospital	Holbaek
Denmark	Department of Gynaecology and obstetrics, Hvidovre University Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Holbaek Sygehus	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (11)

Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. Review. — View Citation

Bolla D, Schöning A, Drack G, Hornung R. Technical aspects of the cesarean section. Gynecol Surg 2010;7:127-32.

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. — View 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. — View 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. — View Citation

Holmgren G, Sjöholm L, Stark M. The Misgav Ladach method for cesarean section: method description. Acta Obstet Gynecol Scand. 1999 Aug;78(7):615-21. — View Citation

Jenkins TR. It's time to challenge surgical dogma with evidence-based data. Am J Obstet Gynecol. 2003 Aug;189(2):423-7. Review. — View 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. — View Citation

Mathai M, Hofmeyr GJ. Abdominal surgical incisions for caesarean section. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD004453. Review. Update in: Cochrane Database Syst Rev. 2013;5:CD004453. — View Citation

Nikolajsen L, Sørensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	The difference in pain between the two sides of the scar	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	No
Secondary	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	No
Secondary	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	No
Secondary	Infection	The rate of postoperative infection and what side of the scar - right or left -that is infected.	7 days	No
Secondary	Infection	The rate of postoperative infection and what side of the scar - right or left -that is infected.	1 and 3 months postoperatively	No