Does Rectus Re-approximation Cause Adhesion After Cesarean Section?

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstetric Complication; Muscle Injury
• Intervention / Treatment: Procedure: Rectus muscle re-approximation

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Giresun, Turkey
    • Sebnem Alanya Tosun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Primary cesarean section

Exclusion Criteria:

• Wound infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Study group; This arm is going to include the patients who are performed rectus reapproximation.	Procedure: Rectus muscle re-approximation; Study group: we are going to re-approximate rectus muscle wirth minimum 3 stiches.
NO_INTERVENTION: Control group; This arm is going to include the patients who are not performed rectus reapproximation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	Operation time in minutes is going to be recorded	During operation
Postoperative pain	VAS scale is going to be used.	3 months after cesarean section
Postoperative bowel function	It is going to be evaluated by self developed questionnaire.	3 months after cesarean section
Postoperative bladder function	It is going to be evaluated by self developed questionnaire.	3 months after cesarean section

Collaborators and Investigators

• Sponsor: Giresun University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2020
• Primary Completion (ANTICIPATED): August 25, 2021
• Study Completion (ANTICIPATED): September 25, 2021

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (ACTUAL): July 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: elastography; rectus muscle re-approximation
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: Rectus-reapproximation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No