Clinical trial NCT05080114: Vaginal Cuff Closure by Modification of the Bakay Technique in Total Laparoscopic Hysterectomy
Official title: A Multimodal Concept for Vaginal Cuff Closure by Modification of the Bakay Technique in Total Laparoscopic Hysterectomy: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Surgery
Laparoscopy
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total operative time
timeFrame: Intraoperative, During the surgery
measure: Surgical complications
timeFrame: During the surgery, at 7th, 30th and 90th day after the surgery.
measure: Vaginal length
timeFrame: Postoperative, at 90th day after the surgery.
measure: Patient Satisfaction
timeFrame: Postoperative, at 90th day after the surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Egemed Hospital
city: Samsun
country: Turkey
facility: Samsun Ondokuz Mayis University
Study officials:
affiliation: Ondokuz Mayis Universitesi
name: Kadir Bakay, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.