Clinical trial NCT04156282: Knot Burial Technique for Rectus Sheath Closure
Official title: Knot Burial Technique for Rectus Sheath Closure in Relation to Post Operative Pain in Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 358
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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:
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: changing the post operative pain and discomfort
timeFrame: the first twenty-four hours after delivery.
measure: changing the post operative pain and discomfort
timeFrame: one week after delivery
measure: changing the post operative pain and discomfort
timeFrame: two weeks after delivery.
Secondary outcomes:
measure: wound assessment for suture granuloma formation
timeFrame: one week post operative
measure: early ambulation after cesarean section
timeFrame: two hours after delivery
measure: early breast feeding after cesarean section
timeFrame: two hours after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Ibrahim
Study officials:
affiliation: AinShams University
name: Nashwa elsaid, prof.Dr
role: STUDY_DIRECTOR
affiliation: AinShams University
name: Reda Mokhtar, Lecture
role: STUDY_DIRECTOR
References: