NCT01297725

Brief 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. 1.The preferred side evaluated by the patient 3 months postoperatively.
  2. 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. 3.The rate and side of infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 19, 2011

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

February 16, 2011

Last Update Submit

October 18, 2011

Conditions

Cesarean Section

Keywords

Cesarean sectionCesarean section[*methods]Fascia [*surgery]Randomized Controlled TrialAbdominal Wall [*surgery]Pain, postoperativeSurgical wound infection

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (6)

  • The difference in pain between the two sides of the scar

    1, 3 and 7 days postoperatively

  • The difference in pain between the two sides of the scar

    1 and 3 months postoperatively

  • Pain on the two sides of the scar

    1, 3 and 7 days postoperatively

  • Pain in the two sides of the scar

    1 and 3 months postoperatively

  • Infection

    7 days

  • +1 more secondary outcomes

Study Arms (2)

Right sharp, left blunt

EXPERIMENTAL

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

Right blunt, left sharp

EXPERIMENTAL

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

Interventions

Blunt right, sharp leftPROCEDURE

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

Right blunt, left sharp
Blunt left, sharp rightPROCEDURE

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

Right sharp, left blunt

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Gynaechology and Obstetrics, Holbaek Hospital

Holbæk, 4300, Denmark

Location

Department of Gynaecology and obstetrics, Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (12)

  • 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.

    PMID: 14674981BACKGROUND

  • 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.

    PMID: 14520211BACKGROUND

  • 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.

    PMID: 20840692BACKGROUND

  • 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.

    PMID: 18336721BACKGROUND

  • 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.

    PMID: 16260200BACKGROUND

  • 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.

    PMID: 17253508BACKGROUND

  • 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.

    PMID: 12421172BACKGROUND

  • 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.

    PMID: 10422908BACKGROUND

  • 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.

    PMID: 8194647BACKGROUND

  • 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.

    PMID: 12113971BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 24275233DERIVED

MeSH Terms

Conditions

Pain, PostoperativeSurgical Wound Infection

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsWound InfectionInfections

Study Officials

  • Niels Jørgen Secher, Professor, M.D.

    Dep. Gynaecology and Obstetrics, Hvidovre University Hospital

    STUDY CHAIR

  • Anna Aabakke, M.D.

    Dep. Gynaecology and Obstetrics, Holbaek Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anna Aabakke

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 17, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

October 19, 2011

Record last verified: 2011-10

Locations

DK(2)