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

Not Applicable

Completed

• Conditions: Hysterectomy; Laparoscopy; Surgery
• Interventions: Procedure: Standard technique (ST); Procedure: Modified Bakay technique (MT)

• Registration Number: NCT05080114
• Lead Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

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.

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2020-09-30
• Study Completion: 2021-01-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-02
• Study First Submitted QC: 2021-10-02
• Last Update Submitted: 2021-10-02
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard technique (ST)	Standard technique (ST)	The conventional standard total laparoscopic hysterectomy technique was used in this control group.
Modified technique (MT)	Modified Bakay 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.

Primary Outcome Measures

Name	Time	Method
Total operative time	Intraoperative, During the surgery	Time interval between the placement and removal of primary trocar, as measured with minutes.
Surgical complications	During the surgery, at 7th, 30th and 90th day after the surgery.	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).
Vaginal length	Postoperative, at 90th day after the surgery.	The length of vagina from cervix to introitus, as measured with vaginal measuring ruler by cm.
Patient Satisfaction	Postoperative, at 90th day after the surgery.	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.

Trial Locations

Locations (2)

Egemed Hospital; 🇹🇷 Aydin, Turkey

Samsun Ondokuz Mayis University; 🇹🇷 Samsun, Turkey