HysterectomyNCT05080114
Vaginal Cuff Closure by Modification of the Bakay Technique in Total Laparoscopic Hysterectomy
A study testing Modified Bakay technique (MT) and Standard technique (ST) in people with Hysterectomy and Surgery, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy, Surgery, Laparoscopy
- What is being tested?
- Modified Bakay technique (MT) and Standard technique (ST)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who needed laparoscopic hysterectomy
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Egemed Hospital
Aydin
Samsun Ondokuz Mayis University
Samsun
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Hysterectomy, Surgery, Laparoscopy
- Being tested
- Modified Bakay technique (MT), Standard technique (ST)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Bakay technique (MT)Procedure or surgery
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.
Standard technique (ST)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Modified technique (MT) | Experimental | 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. Receives: Procedure: Modified Bakay technique (MT) |
| Standard technique (ST) | Active comparator | The conventional standard total laparoscopic hysterectomy technique was used in this control group. Receives: Procedure: Standard technique (ST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total operative time
Time interval between the placement and removal of primary trocar, as measured with minutes.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Postoperative, at 90th day after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Nov 2018
- Primary completion30 Sep 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uzeyir Kalkan, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Investigators
- Kadir Bakay, Assoc Prof, Principal investigator, Ondokuz Mayis Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080114
- Sponsor's protocol ID
- OMU KAEK 2018/22
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon request from Uzeyir Kalkan (uzekal@hotmail.com).
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.
PubMed 29602001Kalkan 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.
PubMed 34996427
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Concept for Vaginal Cuff Closure by Modification of the Bakay Technique in Total Laparoscopic Hysterectomy: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05080114
- Acronym / sponsor ID
- OMU KAEK 2018/22
- Conditions
- Hysterectomy, Surgery, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified technique (MT) | Experimental | Procedure: 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. |
| Standard technique (ST) | Active comparator | Procedure: Standard technique (ST)The conventional standard total laparoscopic hysterectomy technique was used in this control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who needed laparoscopic hysterectomy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Modified technique (MT) |
| 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. | Procedure or surgery | Standard technique (ST) |
Primary outcome
Total operative time
Time frame: Intraoperative, During the surgery
Time interval between the placement and removal of primary trocar, as measured with minutes.
Surgical complications
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Background: PubMed 29602001Bakay 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.
- Derived from this study: PubMed 34996427Kalkan 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.
- Individual participant dataSharing planned: No. Data will be shared upon request from Uzeyir Kalkan (uzekal@hotmail.com).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kadir Bakay, Assoc Prof principal investigator
Ondokuz Mayis Universitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Bakay technique (MT) and Standard technique (ST) in people with Hysterectomy and Surgery, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total operative time (time frame: Intraoperative, During the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05080114, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.