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NCT03701048 Clinical Trial

Rectus Musle Reapproximation During Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:
Intraoperative and Postoperative Results of Rectus Musle Reapproximation During Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03701048
Other study ID # 2018/10
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date April 1, 2022

Study information
Verified date January 2024
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During Cesarean section in Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.

Description:

Pfannenstiel incision will be done under general or spinal anesthesia. The abdomen will be opened and fetus and placenta will be delivered. Then the abdomen will be closed. In Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date April 1, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 18-40 years old women undergoing cesarean section Exclusion Criteria: - grandmultiparas

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cesarean Section
Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed.

Locations
Country Name City State
Turkey Kanuni SSRTH Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Lyell DJ, Naqvi M, Wong A, Urban R, Carvalho B. Rectus Muscle Reapproximation at Cesarean Delivery and Postoperative Pain: A Randomized Controlled Trial. Surg J (N Y). 2017 Aug 11;3(3):e128-e133. doi: 10.1055/s-0037-1604074. eCollection 2017 Jul. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative pain: Visual Analog Score Visual Analog Scores, minimum score is 0, maximum score is 10. Score 10 represents highest pain score. 24 hours after the procedure
Primary Postoperative interrectus distance Distance between the margins of the rectus muscles in centimeters will be measured with ultrasonography 6 weeks after the procedure
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