Does Rectus Re-approximation Cause Adhesion After Cesarean Section?

• Sponsor: Giresun University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04483986
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obstetric Complication; Muscle Injury	Procedure: Rectus muscle re-approximation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Radiologist is blind.
• Primary Purpose: Prevention
• Official Title: The Evaluation of Rectus Re-approximation in Terms of Adhesion After Cesarean Section by Elastography.
• Actual Study Start Date: May 25, 2020
• Anticipated Primary Completion Date: Aug 25, 2021
• Anticipated Study Completion Date: Sep 25, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Rectus muscle stiffness [3 months after cesarean section]

   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

1. Operation time [During operation]

   Operation time in minutes is going to be recorded

2. Postoperative pain [3 months after cesarean section]

   VAS scale is going to be used.

3. Postoperative bowel function [3 months after cesarean section]

   It is going to be evaluated by self developed questionnaire.

4. Postoperative bladder function [3 months after cesarean section]

   It is going to be evaluated by self developed questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Primary cesarean section

Exclusion Criteria:

• Wound infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sebnem Alanya Tosun	Giresun		Turkey

Sponsors and Collaborators

• Giresun University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sebnem Alanya Tosun, Assistant Professor, Giresun University
• ClinicalTrials.gov Identifier: NCT04483986
• Other Study ID Numbers: Rectus-reapproximation
• First Posted: Jul 23, 2020
• Last Update Posted: Aug 6, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sebnem Alanya Tosun, Assistant Professor, Giresun University: elastography; rectus muscle re-approximation
• Additional relevant MeSH terms: Tissue Adhesions

Study Results

No Results Posted as of Aug 6, 2021