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临床试验/NCT04156282
NCT04156282已完成不适用

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 358 人开始时间: 2019年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
358
试验地点
1
主要终点
changing the post operative pain and discomfort

研究概览

简要总结

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.

详细描述

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

  1. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Term pregnancy ( more than 37 weeks of gestation ) candidate for transverse incision elective cesarean delivery

排除标准

  • 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.

结局指标

主要结局

changing the post operative pain and discomfort

时间窗: two weeks after delivery.

by Visual Analogue pain Scale from ,(0) which means no pain to ( 10) means sever pain.

次要结局

  • early ambulation after cesarean section(two hours after delivery)
  • early breast feeding after cesarean section(two hours after delivery)
  • wound assessment for suture granuloma formation(one week post operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aliaa Ibrahim Gaber Elsayed

Principal investigator

Ain Shams University

研究点 (1)

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