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

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

Status: Completed

Conditions: Laparoscopy; Surgery; Hysterectomy

Treatments: Procedure: Standard technique (ST); Procedure: Modified Bakay technique (MT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05080114

OMU KAEK 2018/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 2 patient groups

Modified technique (MT)

Experimental group

Description:

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.

Treatment:

Procedure: Modified Bakay technique (MT)

Standard technique (ST)

Active Comparator group

Description:

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

Treatment:

Procedure: Standard technique (ST)