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

A Multimodal Concept for Vaginal Cuff Closure by Modification of the Bakay Technique in Total Laparoscopic Hysterectomy: A Randomized Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Hysterectomy; Laparoscopy
• Intervention / Treatment: Procedure: Modified Bakay technique (MT); Procedure: Standard technique (ST)

Detailed Description

The basis for minimizing the rate of severe haemorrhage and ureteral injuries, the most serious events related to these steps, is meticulous dissection providing a clear operative field and the skill and experience of the surgeon. In total laparoscopic hysterectomy (TLH), the altered anatomy after the removal of the uterus may cause the retraction of vagina and shifting of neighbouring structures such as bladder and/or bowel to this pouch, thereby, leading to obstruction of the operative field for vaginal cuff closure.

Bakay published his novel colpotomy and cuff closure technique for TLH. It was the first to describe placing a single continuous running purse-string suture facilitating the cuff closure before colpotomy. The main advantage of the technique involved retrieving the safe suture margins required for vaginal cuff closure before the pelvic anatomy was altered by the removal of the uterus.

In addition to this advantage, we modified the technique to achieve a better cuff healing and standardized apical support and the modified Bakay technique (MT) proposes:

i) placing a single continuous running purse-string suture for vaginal cuff closure before the pelvic anatomy is altered by the colpotomy and removal of the uterus;

ii) suspension/plication of USLs (as a well-defined, efficient, concomitant apical support procedure to prevent future vaginal vault prolapse) routinely in each case before colpotomy while the margins of these ligaments and adjacent structures such as ureters are still prominent and pelvic anatomy is not altered; and

iii) using cold-knife colpotomy instead of electrosurgical colpotomy to support the primary healing of the vaginal cuff. In the present study, we aimed to compare the surgical and clinical outcomes of the MT to standard technique (ST) in patients undergoing TLH.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Aydin, Turkey
    • EgeMed Hospital
  • Samsun, Turkey
    • Samsun Ondokuz Mayis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients who needed laparoscopic hysterectomy

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified technique (MT); 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); 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.
Active Comparator: Standard technique (ST); The conventional standard total laparoscopic hysterectomy technique was used in this control group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Investigators: Principal Investigator: Kadir Bakay, Assoc Prof, Ondokuz Mayis Üniversitesi

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: October 2, 2021
• First Submitted That Met QC Criteria: October 2, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 2, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: OMU KAEK 2018/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared upon request from Uzeyir Kalkan (uzekal@hotmail.com).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No