Closure vs Non Closure of Rectus Muscle at Cesarean Section 5 Year Study

Closure vs Non Closure of Rectus Muscle at Cesarean Section Reducing Post Cesarean Adhesions

approximation of both recti during lower segment cesarean section may be an important step to lower incidence of intraabdominal adhesions . peritoneal adhesions are of major medical importance and are associated with clinical problems such as chronic pain and infertility.

Study Overview

• Status: Recruiting
• Conditions: Intraperitoneal Adhesions After Rectus Muscles Approximation
• Intervention / Treatment: Procedure: approximation of both rectus muscles

Detailed Description

all patients included in the study should be had the operative history of the previous cesarean section and were done in the cairo university and divid them into 2 groups. 1st group were both recti approximated while the second group were closed without approximating both recti. all patients will be subjected to lower segment cesarean segment to assess the intraperitoneal adhesions, mean operative time, mean hospital stay, postoperative distension, bowel sounds, postoperative infections and morbidity

• Study Type: Observational
• Enrollment (Anticipated): 360

Contacts and Locations

• Study Contact: Name: hany saad, assisstant prof; Phone Number: 01001817211; Email: hanysaad25280@gmail.com
• Study Contact Backup: Name: hadeer meshaal, assistant prof; Phone Number: 01001435238; Email: dr_hadeer@live.com

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Recruiting
    • Cairo University
    • Contact: hany saad, assistant prof; Phone Number: 01001817211; Email: hanysaad25280@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

patients who will subjected to cesarean section with history of previous cesarean section in the same hospital with operative notes and techniques

Description

Inclusion Criteria:

• all patients of first lower segment cs at kasr al ainy with previous recorded data including operative data, postoperative data including complications. all patients included in the study are elective cesarean section at 38 weeks of gestation

Exclusion Criteria:

• no history of infection or medical disease
• no history of previous laparotomies
• no history of pregnancy complications
• patients noted to have intraperitoneal adhesions in first cesarean section

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
approximation of both recti group	Procedure: approximation of both rectus muscles; closure of both rectus muscle before closure of rectus sheeth
non approximation of both recti group	Procedure: approximation of both rectus muscles; closure of both rectus muscle before closure of rectus sheeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of the intraperitoneal adhesions post rectus muscle closure	assessment of adhesions bands between the pelvic organs and bowel	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean operative time	calculate the mean time for closure of both recti	intraopertive time
mean hospital stay	assess the postoperative time of hospital stay	posoperative within first 48 hrs
mean postoperative bowel sounds	interval between operation and listening the bowel sounds	posoperative within 24 hrs
postoperative distension	assessment of bowel distension postoperative	posoperative within 24 hrs
postoperative morbidity and infections	assess the tempreture, scars	posoperative within 1 week

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (ACTUAL): September 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: assisstant professor

Drug and device information, study documents

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