Knot Burial Technique for Rectus Sheath Closure

Study Overview
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Brief Summary
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Caesarean section is one of the most commonly performed abdominal operations on women in most countries of the world. Its rate has increased markedly in recent years, and is about 20-25% of all child-births in most developed countries. The present study was a step to reduce postoperative pain in cesarean sections. Because of the large number of women that undergo caesarean section, even small differences in post-operative morbidity rates due to different techniques could translate into improved health and significant savings of cost and health services resources. Closing the rectus sheath in cesarean sections with the knots pricking through the skin causes significant postoperative pain, discomfort and delayed ambulation. No comments in literature regarding the best way for closing the rectus sheath in cesarean sections. AIM/ OBJECTIVES The aim of this study is to assess the efficacy of burying knots beneath the rectus sheath during cesarean section in reducing post operative pain and discomfort. Study hypothesis: In women undergoing cesarean sections may or may not burying knots beneath the rectus sheath reduce the post operative pain and discomfort.

Detailed Description
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Non absorbable and delayed absorbable monofilament materials require meticulous care to prevent knot slippage. One common problem that arises from use of these materials is the discomfort caused by the knot pricking through the skin. Although this is a common problem after cesarean section, it is often overlooked and only very few preventive techniques have been described. This study is to assess the efficacy of burying knots beneath the rectus sheath during cesarean sections in reducing post operative pain and discomfort. Type of Study : A randomized controlled clinical trial. Study Setting :this study will be conducted at the department of Obstetrics and Gynecology at Ain-Shams University Maternity hospital. Study time: 2019. Study Population : The study population comprises pregnant women, fulfilling the inclusion criteria, attending to Ain Shams University Maternity Hospital, during the study period, who are planned for cesarean delivery.

Official Title
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Knot Burial Technique for Rectus Sheath Closure in Relation to Post Operative Pain in Elective Cesarean Section

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Procedure: knot burial technique
* Procedure: classical closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term pregnancy ( more than 37 weeks of gestation ) candidate for transverse incision elective cesarean delivery Exclusion Criteria: patient with BMI >30 and fat thickness >3 cm. patient with haemoglobin less than 10g/dL patient with previous history of septic wound. Emergency lower segment cesarean section. Patients complaining of premature rupture of membrane. Patients need intra abdominal drains post cesarean sections Patients with established or gestational diabetes, coagulation defects, hemodynamic instability, septicemia or chorioamnionitis.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: we will analyze 400 candidate for elective cesarean sections, divided into two groups ,each of 200 patients according to the rectus sheath closure:
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: classical closure.<br>In this group, the rectus sheath closure will be done by simple running continuous sutures with the knots beneath the subcutaneous layer. | Procedure: classical closure<br>* surgical suturing intervention<br>|
| Active Comparator: knot burial technique<br>The surgeon holds the left angle of the rectus sheath incision with an Allis. Using (Polyglactin 910) suture,The needle is taken from the inside outward on the upper edge.The needle is then taken lateral to the Allis and brought back into the wound by taking it through the inferior edge from outside to inside . A square knot is tied with three or four throws. The needle is then taken out of the wound through the upper edge and continuous running stitches . As the right angle is approached, the angle is held with an Allis. the suture, will be taken through the lower edge, is brought outside the wound and passed between the blades of a closed Allis before taking it inside out on the upper edge. One more bite is taken but this time just lateral to the Allis holding the angle, and the needle is brought back into the wound and to the outside between the edges of the rectus sheath. Using the loop of polyglactin held with the Allis , an Aberdeen knot is tied after removing the Allis. | Procedure: knot burial technique<br>* surgical suturing intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changing the post operative pain and discomfort | by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain. | the first twenty-four hours after delivery. | 
| changing the post operative pain and discomfort | by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain. | one week after delivery | 
| changing the post operative pain and discomfort | by Visual Analogue pain Scale from ,(0) which means no pain to ( 10) means sever pain. | two weeks after delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound assessment for suture granuloma formation | by scar tissue palpation for ( presence ) or (absence) of a forming mass. | one week post operative | 
| early ambulation after cesarean section | by observation and history taking , early ambulation within two hours post operative (yes) or (no) | two hours after delivery | 
| early breast feeding after cesarean section | by observation and history taking, early breast feeding within two hours post operative (yes) or (no) | two hours after delivery |