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

NCT05080114 | Completed

• 1 other identifier: OMU KAEK 2018/22
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

Brief Summary

Modified Bakay technique offers a novel colpotomy and cuff closure technique for total laparoscopic hysterectomy (TLH), and consists of placing a single continuous running purse-string suture facilitating the cuff closure before colpotomy. The modified Bakay technique adds a standard apical compartment support and has the potential to facilitate the primary healing of the vaginal cuff. This study aimed to compare the surgical and clinical outcomes of the Modified Bakay technique to conventional standard technique in patients undergoing TLH.

Conditions

Hysterectomy; Surgery; Laparoscopy

Outcome Measures

Primary Outcomes (4)

• Total operative time

  Time interval between the placement and removal of primary trocar, as measured with minutes.

  Intraoperative, During the surgery

• Surgical complications

  Intraoperative and postoperative complications related with the surgery. Any minor and major (e.g., bowel injury, bleeding\>300cc, major vessel injury, bowel injury, haematoma, infection) complications will be classified according to the Clavien-Dindo classification system. This system allows to grade the adverse events between any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention (Grade 1), complications requiring drug treatments (Grade 2), Complications requiring surgical, endoscopic or radiological intervention (Grade 3), Life-threatening complications (Grade 4) and to the death of the patient (Grade 5).

  During the surgery, at 7th, 30th and 90th day after the surgery.

• Vaginal length

  The length of vagina from cervix to introitus, as measured with vaginal measuring ruler by cm.

  Postoperative, at 90th day after the surgery.

• Patient Satisfaction

  Patient satisfaction will be measured with Patient Global Impression of Improvement (PGI-I). It is scored as: Very much better (1), Much better (2), A little better (3), No change (4), A little worse (5), Much worse (6), Very much worse (7). Patient reported as Very much better or much better will be regarded as satisfied.

  Postoperative, at 90th day after the surgery.

Study Arms (2)

Modified technique (MT)

EXPERIMENTAL

All the steps of the laparoscopic hysterectomy were performed according to conventional standard technique until the colpotomy step. Instead, the modified Bakay technique was used for later on.

Procedure: Modified Bakay technique (MT)

Standard technique (ST)

ACTIVE COMPARATOR

The conventional standard total laparoscopic hysterectomy technique was used in this control group.

Procedure: Standard technique (ST)

Interventions

Modified Bakay technique (MT) PROCEDURE

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.

Modified technique (MT)

Standard technique (ST) PROCEDURE

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.

Standard technique (ST)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who needed laparoscopic hysterectomy

You may not qualify if:

• Patients with anaesthetic contraindications to laparoscopy
• premalignant or malignant genital disease
• prior pelvic and/or abdominal radiotherapy
• large adnexal masses; large fibroids obscuring the visualization of the cervicovaginal junction
• Suspicion of malignancy
• Pelvic organ prolapse Stage \>2

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (2)

Egemed Hospital

Aydin, Turkey (Türkiye)

Location

Samsun Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Location

Related Publications (2)

• Bakay K. Introduction of a Novel Modification in Laparoscopic Hysterectomy: The Bakay Technique. J Minim Invasive Gynecol. 2018 Jul-Aug;25(5):916-919. doi: 10.1016/j.jmig.2018.03.013. Epub 2018 Mar 27.

  PMID: 29602001 BACKGROUND

• Kalkan U, Bakay K. A multimodal concept for vaginal cuff closure by modification of the Bakay technique in total laparoscopic hysterectomy: a randomized clinical study. BMC Womens Health. 2022 Jan 8;22(1):6. doi: 10.1186/s12905-021-01591-z.

  PMID: 34996427 DERIVED

Study Officials

• Kadir Bakay, Assoc Prof

  Ondokuz Mayis Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 15, 2021
• Study Start: November 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: January 1, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)