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

Holbaek Sygehus2 sites in 1 country30 target enrollmentJanuary 2011

ConditionsCesarean Section

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cesarean Section
Sponsor: Holbaek Sygehus
Enrollment: 30
Locations: 2
Primary Endpoint: Preferred side of the scar evaluated by the patient 3 months postoperatively
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

The preferred side evaluated by the patient 3 months postoperatively.
The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and 1 and 3 months postoperatively.
The rate and side of infection.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

October 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Holbaek Sygehus

Responsible Party

Principal Investigator

Anna Aabakke

Holbaek Sygehus

Eligibility 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

Outcomes

Primary Outcomes

Preferred side of the scar evaluated by the patient 3 months postoperatively

Time Frame: 3 months

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 Outcomes

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(1 and 3 months postoperatively)