Vaginal Cuff Closure by Modification of the Bakay Technique in Total Laparoscopic Hysterectomy

NACompletedINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

November 1, 2018

Primary Completion Date

September 30, 2020

Study Completion Date

January 1, 2021

Conditions
HysterectomySurgeryLaparoscopy
Interventions
PROCEDURE

Modified Bakay technique (MT)

The conventional standard technique for laparoscopic hysterectomy was followed until the colpotomy. The remaining steps were as follows: A 0-Monocryl™ violet (poliglecaprone-25) or a 0-PDS-II (polydioxanone) suture with a 36-mm needle (Ethicon Inc., NJ, USA) was placed first on the right USL, proximal to the ischial spine and 1-3 cm away from its uterine insertion, then helically proceeded by 1 to 3 bite(s) (depending on the length of the ligament) for suspension/plication. The suture continued circumferentially in counter clockwise direction on the line between the cervicovaginal junction and the bladder in a full-thickness purse string fashion, at least 1 cm away to the bladder. This suture symmetrically ended in the left USL, with forming nearly an Ohm sign (Ω). Colpotomy was performed circumferentially using laparoscopic cold scissors and/or knife, maintaining a safe distance from the suture line. Following removal of the uterus, both ends of the prior suture line were knotted.

PROCEDURE

Standard technique (ST)

"The conventional standard total laparoscopic hysterectomy technique was used in this control group.~All operations were performed under general anaesthesia with nasogastric intubation and a bladder catheter in place. Cefazolin 2 g was administered to all patients for prophylaxis 30 min prior to surgery. Operations were performed with a 10-mm laparoscope (Karl Storz, Germany) through the trocar placed usually in the umbilicus. Two lateral 5-mm trocars and one midline 10-mm trocar were used. The placement of trocars varied according to the uterine size. Haemostasis was usually performed using bipolar forceps (Karl Storz Robi, Germany), whereas dissection was performed using the LigaSure™ (Covidien, Medtronic, USA). Maryland jaw laparoscopic sealer/divider, bipolar forceps and scissors. Colpotomy was performed with electrocautery devices and sutured intracorporeally."

Trial Locations (2)

Unknown

Egemed Hospital, Aydin

Samsun Ondokuz Mayis University, Samsun

All Listed Sponsors
lead

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

OTHER

NCT05080114 - Vaginal Cuff Closure by Modification of the Bakay Technique in Total Laparoscopic Hysterectomy | Biotech Hunter | Biotech Hunter