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Cesarean SectionNCT01297725

Sharp Versus Blunt Fascial Incision at Caesarean Section

A study testing Blunt right, sharp left and Blunt left, sharp right in people with Cesarean Section, run by Holbaek Sygehus at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Cesarean Section
What is being tested?
Blunt right, sharp left and Blunt left, sharp right
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesDenmark
Study dates
Jan 2011to Oct 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Department of Gynaechology and Obstetrics, Holbaek Hospital

    Holbæk, 4300

  • Department of Gynaecology and obstetrics, Hvidovre University Hospital

    Hvidovre, 2650

Other trials in Denmark

About this study

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.

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.
Being tested
Blunt right, sharp left, Blunt left, sharp right
Keywords
Cesarean section, Cesarean section[*methods], Fascia [*surgery], Randomized Controlled Trial, Abdominal Wall [*surgery], Pain, postoperative, Surgical wound infection
Medical subject headings
Pain, Postoperative, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blunt right, sharp leftProcedure or surgery

    Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline.

  • Blunt left, sharp rightProcedure or surgery

    Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline.

Study groups in NCT01297725
Study groupRoleWhat they receive
Right sharp, left bluntExperimentalBlunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline.
Receives: Procedure: Blunt left, sharp right
Right blunt, left sharpExperimentalBlunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline.
Receives: Procedure: Blunt right, sharp left

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (6)

  1. 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.

    Measured: 1, 3 and 7 days postoperatively

  2. 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.

    Measured: 1 and 3 months postoperatively

  3. 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.

    Measured: 1, 3 and 7 days postoperatively

  4. 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.

    Measured: 1 and 3 months postoperatively

  5. Infection

    The rate of postoperative infection and what side of the scar - right or left -that is infected.

    Measured: 7 days

  6. Infection

    The rate of postoperative infection and what side of the scar - right or left -that is infected.

    Measured: 1 and 3 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJul 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01297725
Sponsor's protocol ID
Fascia Study
Other IDs
H-2-2010129
Status last verified
Oct 2011
First submitted
16 Feb 2011
Last updated
19 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 14674981

  • 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.

    PubMed 14520211

  • 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.

    PubMed 20840692

  • 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.

    PubMed 18336721

  • 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.

    PubMed 16260200

  • 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.

    PubMed 17253508

  • 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.

    PubMed 12421172

  • 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.

    PubMed 10422908

  • 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.

    PubMed 8194647

  • 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.

    PubMed 12113971

  • 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.

    PubMed 24275233

Questions about this trial

What is this clinical trial studying?

A study testing Blunt right, sharp left and Blunt left, sharp right in people with Cesarean Section, run by Holbaek Sygehus at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preferred side of the scar evaluated by the patient 3 months postoperatively (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01297725, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2011.

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