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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
  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:

  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.

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 November 20, 2014