Uterine DiseasesNCT05823935
Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions
A study testing Bakay purse string and Cuff closure via vaginal route group in people with Uterine Diseases, run by Mansoura University at 1 site in Egypt.
Trial summary
To compare vaginal cuff closure via Bakay purse string with vaginal cuff closure via vaginal route with continuous locked suturing after total laparoscopic hysterectomy for benign lesions. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Uterine Diseases
- What is being tested?
- Bakay purse string and Cuff closure via vaginal route group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2022to Nov 2023
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign uterine lesions e.g fibroid, adenomyosis,…etc.
- Patient acceptance to undergo laparoscopic hysterectomy.
Who cannot join
- Gynecological malignancy.
- Low corporeal myoma obsecuring cervicovaginal junction.
- History of extensive abdominal surgery other than cesarean section.
Trial locations and contacts
1 site in 1 country.
Mohamed S Abdelhafez, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
About this study
Official title: Laparoscopic Versus Vaginal Cuff Closure During Laparoscopic Hysterectomy in Benign Gynecological Lesions
To compare vaginal cuff closure via Bakay purse string with vaginal cuff closure via vaginal route with continuous locked suturing after total laparoscopic hysterectomy for benign lesions.
Read the detailed description
The objective of the present study is to compare 2 different methods for vaginal cuff closure after total laparoscopic hysterectomy for benign lesions regarding operative time, vaginal length, vaginal cuff dehiscene, hematoma formation. The first method is the Bakay purse string and the second is the closure of the vault via vaginal route with continuous locked suturing.
- Conditions
- Uterine Diseases
- Being tested
- Bakay purse string, Cuff closure via vaginal route group
- Keywords
- TLH, Bakay purse string
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bakay purse stringProcedure or surgery
After developing the bladder flap, Vicryl polyglactin 910 sutures (Ethicon, Inc, Somerville, NJ) will be placed on the line between the cervicovaginal junction and the bladder starting at either 4 to 3 o'clock or 8 to 9 o'clock, as anchor sutures. Paying attention not to get closer than 1 cm to the bladder, the first suture will be passed from 4 o'clock to 3 o'clock and continued circumferentially in a full-thickness purse string fashion through 3, 1, 10, 8, 7, 5 o'clock completing a circle while including both uterosacral ligaments.
Cuff closure via vaginal route groupProcedure or surgery
After the uterus will be removed via vaginal route, vaginal cuff ends will be grasped via vaginal approach and sutured continuous locked sutures using Vicryl polyglactin 910 sutures in one layer.
| Study group | Role | What they receive |
|---|---|---|
| Bakay purse string group | Active comparator | Bakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions. Receives: Procedure: Bakay purse string |
| Cuff closure via vaginal route group | Active comparator | Vaginal cuff closure via vaginal route with continuous locked suturing will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions. Receives: Procedure: Cuff closure via vaginal route group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total operative time
The time between placement of the operative ports and successful closure of the vaginal cuff
Measured: From start to end of operation
Operative time for colpotomy and vaginal cuff closure
The time between first anchor suture placement and successful closure of the vaginal cuff
Measured: From start colpotomy to end of vaginal cuff closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start5 Nov 2022
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine DiseasesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Elashry, MSc, Principal investigator, Mansoura UniversityHamed M Youssef, MD, Study chair, Mansoura UniversityMaged R Elshamy, MD, Study director, Mansoura UniversityMahmoud M Awad, MD, Study director, Mansoura UniversityMohamed S Abdelhafez, MD, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823935
- Sponsor's protocol ID
- MD.22.10.703
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Vaginal Cuff Closure During Laparoscopic Hysterectomy in Benign Gynecological Lesions
- ClinicalTrials.gov ID
- NCT05823935
- Acronym / sponsor ID
- MD.22.10.703
- Conditions
- Uterine Diseases
- Keywords
- TLH, Bakay purse string
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 21 Apr 2023 (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.
To compare vaginal cuff closure via Bakay purse string with vaginal cuff closure via vaginal route with continuous locked suturing after total laparoscopic hysterectomy for benign lesions.
Detailed description
The objective of the present study is to compare 2 different methods for vaginal cuff closure after total laparoscopic hysterectomy for benign lesions regarding operative time, vaginal length, vaginal cuff dehiscene, hematoma formation. The first method is the Bakay purse string and the second is the closure of the vault via vaginal route with continuous locked suturing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bakay purse string group | Active comparator | Procedure: Bakay purse stringBakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions. |
| Cuff closure via vaginal route group | Active comparator | Procedure: Cuff closure via vaginal route groupVaginal cuff closure via vaginal route with continuous locked suturing will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Benign uterine lesions e.g fibroid, adenomyosis,…etc.
- Patient acceptance to undergo laparoscopic hysterectomy.
Key exclusion criteria (3 listed)
- Gynecological malignancy.
- Low corporeal myoma obsecuring cervicovaginal junction.
- History of extensive abdominal surgery other than cesarean section.
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 |
|---|---|---|
| Bakay purse stringAfter developing the bladder flap, Vicryl polyglactin 910 sutures (Ethicon, Inc, Somerville, NJ) will be placed on the line between the cervicovaginal junction and the bladder starting at either 4 to 3 o'clock or 8 to 9 o'clock, as anchor sutures. Paying attention not to get closer than 1 cm to the bladder, the first suture will be passed from 4 o'clock to 3 o'clock and continued circumferentially in a full-thickness purse string fashion through 3, 1, 10, 8, 7, 5 o'clock completing a circle while including both uterosacral ligaments. | Procedure or surgery | Bakay purse string group |
| Cuff closure via vaginal route groupAfter the uterus will be removed via vaginal route, vaginal cuff ends will be grasped via vaginal approach and sutured continuous locked sutures using Vicryl polyglactin 910 sutures in one layer. | Procedure or surgery | Cuff closure via vaginal route group |
Primary outcome
Total operative time
Time frame: From start to end of operation
The time between placement of the operative ports and successful closure of the vaginal cuff
Operative time for colpotomy and vaginal cuff closure
Time frame: From start colpotomy to end of vaginal cuff closure
The time between first anchor suture placement and successful closure of the vaginal cuff
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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.
Mohamed S Abdelhafez, MD contact
Ahmed M Elashry, MSc principal investigator
Mansoura University
Hamed M Youssef, MD study chair
Mansoura University
Maged R Elshamy, MD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bakay purse string and Cuff closure via vaginal route group in people with Uterine Diseases, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Elashry, MSc (+201066556370, elashry11090@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total operative time (time frame: From start to end of operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2023.