Continuous Versus Interrupted Suturing In Repair of Lateral And Mediolateral Episiotomy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ain Shams University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- postoperative pain
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primipara women.
- •Fullterm pregnancy.
- •Lateral or mediolateral episiotomy done in selective rather than liberal episiotomy.
Exclusion Criteria
- •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.
Arms & Interventions
interrupted repair of mediolateral episiotomy
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
Intervention: repair of episiotomy (Procedure)
continous repair of mediolateral episiotomy
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
Intervention: repair of episiotomy (Procedure)
interrupted repair of lateral episiotomy
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
Intervention: repair of episiotomy (Procedure)
continuous repair of lateral episiotomy
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
Intervention: repair of episiotomy (Procedure)
Outcomes
Primary Outcomes
postoperative pain
Time Frame: 6 hours
using visual analogue scale
Secondary Outcomes
- 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)
Investigators
mohammed mahmoud samy
Dr. Mohamed Samy
Ain Shams University