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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05080114
• Other study ID #: OMU KAEK 2018/22
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: October 2021
• Source: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: January 1, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy
• Laparoscopy
• Surgery

Intervention

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 (O). 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.
• 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.

Locations

Country	Name	City	State
Turkey	Egemed Hospital	Aydin
Turkey	Samsun Ondokuz Mayis University	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total operative time	Time interval between the placement and removal of primary trocar, as measured with minutes.	Intraoperative, During the surgery
Primary	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.
Primary	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.
Primary	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.