Sharp Versus Blunt Fascial Incision at Caesarean Section

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Procedure: Blunt left, sharp right; Procedure: Blunt right, sharp left

• Registration Number: NCT01297725
• Lead Sponsor: Holbaek Sygehus

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Primary Completion: 2011-07
• Status Verified: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-18
• Last Update Posted: 2011-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right sharp, left blunt	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.
Right blunt, left sharp	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.

Primary Outcome Measures

Name	Time	Method
Preferred side of the scar evaluated by the patient 3 months postoperatively	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 Outcome Measures

Name	Time	Method
The difference in pain between the two sides of the scar	1 and 3 months postoperatively	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	1, 3 and 7 days postoperatively	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	1 and 3 months postoperatively	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	1 and 3 months postoperatively	The rate of postoperative infection and what side of the scar - right or left -that is infected.

Trial Locations

Locations (2)

Department of Gynaechology and Obstetrics, Holbaek Hospital; 🇩🇰 Holbaek, Denmark

Department of Gynaecology and obstetrics, Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark