Knot Burial Technique for Rectus Sheath Closure
- Conditions
- Cesarean Section Complications
- Registration Number
- NCT04156282
- Lead Sponsor
- Ain Shams University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 358
- Term pregnancy ( more than 37 weeks of gestation ) candidate for transverse incision elective cesarean delivery
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method changing the post operative pain and discomfort two weeks after delivery. by Visual Analogue pain Scale from ,(0) which means no pain to ( 10) means sever pain.
- Secondary Outcome Measures
Name Time Method early ambulation after cesarean section two hours after delivery by observation and history taking , early ambulation within two hours post operative (yes) or (no)
early breast feeding after cesarean section two hours after delivery by observation and history taking, early breast feeding within two hours post operative (yes) or (no)
wound assessment for suture granuloma formation one week post operative by scar tissue palpation for ( presence ) or (absence) of a forming mass.
Trial Locations
- Locations (1)
Ahmed Ibrahim
🇪🇬Cairo, Egypt
Ahmed Ibrahim🇪🇬Cairo, Egypt