Back to resultsDoes Rectus Re-approximation Cause Adhesion After Cesarean Section?
Primary Purpose
Obstetric Complication, Muscle Injury
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rectus muscle re-approximation
Sponsored by
About this trial
This is an interventional prevention trial for Obstetric Complication focused on measuring elastography, rectus muscle re-approximation
Eligibility Criteria
Inclusion Criteria:
- Primary cesarean section
Exclusion Criteria:
- Wound infection
Sites / Locations
- Sebnem Alanya Tosun
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Study group
Control group
Arm Description
This arm is going to include the patients who are performed rectus reapproximation.
This arm is going to include the patients who are not performed rectus reapproximation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Operation time
Operation time in minutes is going to be recorded
Postoperative pain
VAS scale is going to be used.
Postoperative bowel function
It is going to be evaluated by self developed questionnaire.
Postoperative bladder function
It is going to be evaluated by self developed questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04483986
Brief Title
Does Rectus Re-approximation Cause Adhesion After Cesarean Section?
Official Title
The Evaluation of Rectus Re-approximation in Terms of Adhesion After Cesarean Section by Elastography.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
August 25, 2021 (Anticipated)
Study Completion Date
September 25, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Giresun University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Complication, Muscle Injury
Keywords
elastography, rectus muscle re-approximation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Radiologist is blind.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
This arm is going to include the patients who are performed rectus reapproximation.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This arm is going to include the patients who are not performed rectus reapproximation.
Intervention Type
Procedure
Intervention Name(s)
Rectus muscle re-approximation
Intervention Description
Study group: we are going to re-approximate rectus muscle wirth minimum 3 stiches.
Primary Outcome Measure Information:
Title
Rectus muscle stiffness
Description
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.
Time Frame
3 months after cesarean section
Secondary Outcome Measure Information:
Title
Operation time
Description
Operation time in minutes is going to be recorded
Time Frame
During operation
Title
Postoperative pain
Description
VAS scale is going to be used.
Time Frame
3 months after cesarean section
Title
Postoperative bowel function
Description
It is going to be evaluated by self developed questionnaire.
Time Frame
3 months after cesarean section
Title
Postoperative bladder function
Description
It is going to be evaluated by self developed questionnaire.
Time Frame
3 months after cesarean section
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primary cesarean section
Exclusion Criteria:
Wound infection
Facility Information:
Facility Name
Sebnem Alanya Tosun
City
Giresun
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Does Rectus Re-approximation Cause Adhesion After Cesarean Section?
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