An interventional study of repair of episiotomy in Episiotomy Wound, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-04-03.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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:
The Episiotomy in group A will be done 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 Episiotomy in group B will be done using the 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 subgroups subjected to 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. 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, Manufacturer TAISIER-MED Company).
F- Written informed consent will be taken from all women participating in our search.
G- Data recording: age,weight,height,body mass index,type of anesthesia used,type of episiotomy,time taken,infection or gaped episiotomy, amount of bleeding, postpartum hemorrhage,amount of suture material used,amount of analgesia used, severity of pain detected by VAS.
H- all patient will be given oral nonnarcotic analgesics (NSAIDs eg; ibuprofen 600 mg every eight hours for three days , if NSAIDs is contraindicated acetaminophen/ paracetamol 500 mg every eight hours for three days.
I- Antibiotic prophylaxis will be given as a single dose of a broad spectrum antibiotic (second generation cephalosporin or clindamycin if the patient is allergic to penicillin
Exclusion Criteria:
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
Procedure: repair of 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
Procedure: repair of 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
Procedure: repair of 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
Procedure: repair of episiotomy
Different techniques for repair of episiotomy incsicion
postoperative pain
using visual analogue scale
Time frame: 6 hours
Postoperative pain two monthes after delivery.
using VAS
Time frame: TWO MONTHS
Time taken in repair (min)
Time frame: 1 hour
Number of suture ampoules used.
Time frame: 1 hour
Dyspareunia
Dyspareunia reported up to two months after delivery (ACOG;1995). according to Marinoff dyspareunia scale: 0 = no dyspareunia; 1. = causes discomfort, but does not interfere with the frequency of intercourse; 2. = sometimes prevents intercourse; and 3. = completely prevents intercourse.
Time frame: two months
Early complication of episiotomy eg; anal spincter injury, rectal mucosal injury, bleeding or heamatoma formation.
Time frame: 1 hour
Plan to share: No
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Ain Shams University