Sharp Versus Blunt Fascial Incision at Caesarean Section - Full Text View

Purpose

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:

The preferred side evaluated by the patient 3 months postoperatively.
The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and 1 and 3 months postoperatively.
The rate and side of infection.

Condition	Intervention
Cesarean Section	Procedure: Blunt right, sharp left Procedure: Blunt left, sharp right

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

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section Scars

U.S. FDA Resources

Further study details as provided by Holbaek Sygehus:

Primary Outcome Measures:

Preferred side of the scar evaluated by the patient 3 months postoperatively [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The overall preference of scar side - left, right or no difference - taking the entire postoperative 3 months into account as evaluated by the patient.

Secondary Outcome Measures:

The difference in pain between the two sides of the scar [ Time Frame: 1, 3 and 7 days postoperatively ] [ Designated as safety issue: No ]
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.
The difference in pain between the two sides of the scar [ Time Frame: 1 and 3 months postoperatively ] [ Designated as safety issue: No ]
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.
Pain on the two sides of the scar [ Time Frame: 1, 3 and 7 days postoperatively ] [ Designated as safety issue: No ]
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.
Pain in the two sides of the scar [ Time Frame: 1 and 3 months postoperatively ] [ Designated as safety issue: No ]
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.
Infection [ Time Frame: 7 days ] [ Designated as safety issue: No ]
The rate of postoperative infection and what side of the scar - right or left -that is infected.
Infection [ Time Frame: 1 and 3 months postoperatively ] [ Designated as safety issue: No ]
The rate of postoperative infection and what side of the scar - right or left -that is infected.

Estimated Enrollment:	30
Study Start Date:	January 2011
Study Completion Date:	October 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Procedure: 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.
Experimental: 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.	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297725

Locations

Denmark
Department of Gynaechology and Obstetrics, Holbaek Hospital
Holbaek, Denmark, 4300
Department of Gynaecology and obstetrics, Hvidovre University Hospital
Hvidovre, Denmark, 2650

Sponsors and Collaborators

Holbaek Sygehus

Hvidovre University Hospital

Investigators

Study Chair:	Niels Jørgen Secher, Professor, M.D.	Dep. Gynaecology and Obstetrics, Hvidovre University Hospital
Principal Investigator:	Anna Aabakke, M.D.	Dep. Gynaecology and Obstetrics, Holbaek Hospital

More Information

Publications:

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

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

CAESAR study collaborative group. Caesarean section surgical techniques: a randomised factorial trial (CAESAR). BJOG. 2010 Oct;117(11):1366-76.

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.

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

Mathai M, Hofmeyr GJ. Abdominal surgical incisions for caesarean section. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD004453. Review.

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.

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.

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.

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. No abstract available.

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

Responsible Party:	Anna Aabakke, Holbaek Sygehus
ClinicalTrials.gov Identifier:	NCT01297725 History of Changes
Other Study ID Numbers:	Fascia Study, H-2-2010129
Study First Received:	February 16, 2011
Last Updated:	October 18, 2011
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: The Danish Data Protection Agency

Keywords provided by Holbaek Sygehus:

Cesarean section
Cesarean section[*methods]
Fascia [*surgery]
Randomized Controlled Trial

Abdominal Wall [*surgery]
Pain, postoperative
Surgical wound infection

ClinicalTrials.gov processed this record on June 18, 2013