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临床试验/NCT03486132
NCT03486132Unknown不适用

Continuous Versus Interrupted Suturing In Repair of Lateral And Mediolateral Episiotomy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2017年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
240
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

Episiotomy is an incision in the perineum carried out during the second stage of labour to facilitate the birth of an infant. It is an important surgical procedure with physiological, psychological and socio-economic effects on women. Therefore, not only the decision to carry out an episiotomy but also how it is performed and the quality of aftercare are important The two most often performed are the lateral and median episiotomy, as well as mediolateral episiotomy.

Two common methods of repair of episiotomy include continuous and interrupted methods This study aims to compare between postoperative pain following repair of episiotomy by continuous or interrupted suturing.

详细描述

Aim of the work:

This study aims to compare between postoperative pain following repair of episiotomy by continuous or interrupted suturing.

Study population:

All primipara full term women with episiotomy done in a selective rather than liberal use.

E- Patients in the study will be randomized into one of two groups either those who have:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • •Primipara women.
  • •Fullterm pregnancy.
  • •Lateral or mediolateral episiotomy done in selective rather than liberal episiotomy.

排除标准

  • •Risk factor of trauma eg; macrosomia, congenital fetal malformations as (exophthalmous major, hydrocephalus, spinal cord teratoma....etc.
  • •Instrumental delivery.
  • •Primipara refuses to be in the study.
  • •Other techniques of episiotomy.
  • •Preterm onset of labour.
  • •Indication for CS eg; CPD, malposition and malpresentation, fetal distress....etc.
  • •Use of epidural analgesics.
  • •Factors affecting wound healing eg;DM, corticosteroid therapy, chronic debilitating diseases...etc.

研究组 & 干预措施

interrupted repair of mediolateral episiotomy

Other

using the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin.

The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut

干预措施: repair of episiotomy (Procedure)

continous repair of mediolateral episiotomy

Other

continuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0

干预措施: repair of episiotomy (Procedure)

interrupted repair of lateral episiotomy

Other

using the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin.

The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity

干预措施: repair of episiotomy (Procedure)

continuous repair of lateral episiotomy

Other

continuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0

干预措施: repair of episiotomy (Procedure)

结局指标

主要结局

postoperative pain

时间窗: 6 hours

using visual analogue scale

次要结局

  • Postoperative pain two monthes after delivery.(TWO MONTHS)
  • Time taken in repair (min)(1 hour)
  • Number of suture ampoules used.(1 hour)
  • Dyspareunia(two months)
  • Early complication of episiotomy eg; anal spincter injury, rectal mucosal injury, bleeding or heamatoma formation.(1 hour)

研究者

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

mohammed mahmoud samy

Dr. Mohamed Samy

Ain Shams University

研究点 (1)

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