Cesarean Section
Conditions
Keywords
Cesarean section, Cesarean section[*methods], Fascia [*surgery], Randomized Controlled Trial, Abdominal Wall [*surgery], Pain, postoperative, Surgical wound infection
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.
Interventions
PROCEDUREBlunt right, sharp left
Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline.
PROCEDUREBlunt left, sharp right
Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline.
Sponsors
Hvidovre University Hospital
Holbaek Sygehus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The difference in pain between the two sides of the scar | 1, 3 and 7 days postoperatively | 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. |
| 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 | 7 days | The rate of postoperative infection and what side of the scar - right or left -that is infected. |
Countries
Denmark
Outcome results
None listed