Sharp Versus Blunt Fascial Incision at Caesarean Section

Holbaek Sygehus

Status: Completed

Conditions: Cesarean Section

Treatments: Procedure: Blunt right, sharp left; Procedure: Blunt left, sharp right

Study type: Interventional

Funder types: Other

Identifiers

NCT01297725

Fascia Study

H-2-2010129 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Right sharp, left blunt

Experimental group

Description:

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

Treatment:

Procedure: Blunt left, sharp right

Right blunt, left sharp

Experimental group

Description:

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

Treatment:

Procedure: Blunt right, sharp left