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Sharp Versus Blunt Fascial Incision at Caesarean Section

This study has been completed.
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Anna Aabakke, Holbaek Sygehus
ClinicalTrials.gov Identifier:
NCT01297725
First received: February 16, 2011
Last updated: October 18, 2011
Last verified: October 2011
History of Changes

February 16, 2011
October 18, 2011
January 2011
July 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01297725 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Cesarean Section
  • 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.
  • 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 sharp, left blunt
    Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline.
    Intervention: Procedure: Blunt left, sharp right
  • 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.
    Intervention: Procedure: Blunt right, sharp left

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2011
July 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01297725
Fascia Study, H-2-2010129
No
Anna Aabakke, Holbaek Sygehus
Holbaek Sygehus
Hvidovre University Hospital
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
Holbaek Sygehus
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP