Rectus Muscle Re-approximation at Cesarean Delivery

The Value of Rectus Muscle Re-approximation at Cesarean Delivery

We include in our study 200 pregnant women, primigravidas, at term who underwent elective lower segment Cesarean section for the first time among the age group of 20 - 35 years.

The patients are divided randomly into two groups as follows:

• Group (A): undergoing rectus muscle re-approximation
• Group (B): not undergoing rectus muscle re-approximation

Study Overview

• Status: Unknown
• Conditions: Post Cesarean Section Pain
• Intervention / Treatment: Procedure: cesarean section; Procedure: Rectus muscle approximation

Detailed Description

We include in our study 200 pregnant women, primigravidas, at term who underwent elective lower segment Cesarean section for the first time among the age group of 20 - 35 years.

The patients are divided randomly into two groups as follows:

• Group (A): undergoing rectus muscle re-approximation
• Group (B): not undergoing rectus muscle re-approximation
• Examination for diastasis recti abdominis is done for all included patients before delivery, at 6 weeks, and 6 months postpartum. The women are tested in a standardized supine position with arms crossed over the chest. They are instructed to perform an abdominal crunch till the shoulder blades are off the bench. Then we measure the inter-recti distance. If there is no separation or separation ˂ 2 finger breadths so, there is no diastasis recti abdominis. But if the separation is more than 2 finger breadths or more than 4.5 cm so, this is considered diastasis recti abdominis.

The same surgical techniques are used for both groups. All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• primigravida
• undergoing elective Cesarean section

Exclusion Criteria:

• Patients with history of any pelvic or abdominal surgery those having any medical disorder with pregnancy patients with BMI ≥ 40 chronic analgesia use multiple pregnancies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: rectus muscle approximation; All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide	Procedure: cesarean section; All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide; Procedure: Rectus muscle approximation; aprroximation of the lower parts of rectus abdomius muscles during cesarean section
Active Comparator: rectus muscle non approximation; All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide	Procedure: cesarean section; All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	• Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4), patients are asked to read this list of adjectives and select the word that best describes their level of pain on the scale	4 hours after operation

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 13

Drug and device information, study documents

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