Sharp Versus Blunt Fascial Incision at Caesarean Section

Sharp Versus Blunt Fascial Incision at Caesarean Section: A Prospective Randomized Double-blinded Case-Control Study With the Case as it's Own Control.

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Procedure: Blunt left, sharp right; Procedure: Blunt right, sharp left

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Holbaek Sygehus
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (ESTIMATE): February 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 19, 2011
• Last Update Submitted That Met QC Criteria: October 18, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Cesarean section; Randomized Controlled Trial; Pain, postoperative; Surgical wound infection; Cesarean section[*methods]; Fascia [*surgery]; Abdominal Wall [*surgery]
• Other Study ID Numbers: Fascia Study; H-2-2010129 (OTHER: The Danish National Committee on Biomedical Research Ethics)