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Knot Burial Technique for Rectus Sheath Closure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04156282
Enrollment
358
Registered
2019-11-07
Start date
2019-05-09
Completion date
2019-10-14
Last updated
2019-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

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.

Interventions

PROCEDUREknot burial technique

surgical suturing intervention

PROCEDUREclassical closure

surgical suturing intervention

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention 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:

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
changing the post operative pain and discomfortthe first twenty-four hours after delivery.by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain.

Secondary

MeasureTime frameDescription
wound assessment for suture granuloma formationone week post operativeby scar tissue palpation for ( presence ) or (absence) of a forming mass.
early ambulation after cesarean sectiontwo hours after deliveryby observation and history taking , early ambulation within two hours post operative (yes) or (no)
early breast feeding after cesarean sectiontwo hours after deliveryby observation and history taking, early breast feeding within two hours post operative (yes) or (no)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026