Knot Burial Technique for Rectus Sheath Closure

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156282
• Other study ID #: FWA 0000175858
• Status: Completed
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: October 14, 2019

Study information

• Verified date: November 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: October 14, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Procedure:
• knot burial technique
surgical suturing intervention
• classical closure
surgical suturing intervention

Locations

Country	Name	City	State
Egypt	Ahmed Ibrahim	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	changing the post operative pain and discomfort	by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain.	one week after delivery
Primary	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	wound assessment for suture granuloma formation	by scar tissue palpation for ( presence ) or (absence) of a forming mass.	one week post operative
Secondary	early ambulation after cesarean section	by observation and history taking , early ambulation within two hours post operative (yes) or (no)	two hours after delivery
Secondary	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