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NCT04483986 Clinical Trial

Does Rectus Re-approximation Cause Adhesion After Cesarean Section?

Muscle Injury Clinical Trial

Official title:
The Evaluation of Rectus Re-approximation in Terms of Adhesion After Cesarean Section by Elastography.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04483986
Other study ID # Rectus-reapproximation
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 25, 2020
Est. completion date September 25, 2021

Study information
Verified date August 2021
Source Giresun University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rectus re-approximation and periton closure are not the obligatory steps during cesarean section. These steps are due to surgeon's preference. However, there is lack of knowledge about the relation of rectus muscle re-approximation and adhesion formation. We are going to study the rectus muscle stiffness by share-wave elastosonography.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date September 25, 2021
Est. primary completion date August 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Primary cesarean section Exclusion Criteria: - Wound infection

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Rectus muscle re-approximation
Study group: we are going to re-approximate rectus muscle wirth minimum 3 stiches.

Locations
Country Name City State
Turkey Sebnem Alanya Tosun Giresun

Sponsors (1)
Lead Sponsor Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rectus muscle stiffness Share wave elastosonography is going to perform to six different points of rectus muscle. Each points will be 2 cm right or left side of linea alba line in horizontal axis. Two points are on cesarean section incision, next two points 2 cm below the incision and other next two points 2 cm above the incision in vertical axis. Rectus muscle stiffness will show the adhesion formation. 3 months after cesarean section
Secondary Operation time Operation time in minutes is going to be recorded During operation
Secondary Postoperative pain VAS scale is going to be used. 3 months after cesarean section
Secondary Postoperative bowel function It is going to be evaluated by self developed questionnaire. 3 months after cesarean section
Secondary Postoperative bladder function It is going to be evaluated by self developed questionnaire. 3 months after cesarean section
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