Vaginal Vault ProlapseNCT05960292
Laparoscopic Versus Vaginal Approach Closure Complications
A study testing Laparoscopic and Vaginal Hysterectomy in people with Vaginal Vault Prolapse, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Vaginal Vault Prolapse
- What is being tested?
- Laparoscopic and Vaginal Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 30 Apr 2024
- 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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo laparoscopic hysterectomy
- Age ranged from 40 to 80 years.
- Patients suffering from chronic pelvic inflammatory disease (PID)
- Dysfunctional uterine bleeding
- Adenomyosis
- Endometriosis
Show all 9Show fewer
- Fibroid
- Endometrial hyperplasia
- Benign ovarian cyst
Who cannot join
- Patients with known malignancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University hospitals
Cairo, 13111
ElSayed ElDesouky, Assist.Prof, 01092934978, elsayedeldesouky@yahoo.com
Ahmed Altaf, Professor
About this study
Official title: Laparoscopic Versus Vaginal Approach Closure Complications of Vaginal Vault in Laparoscopic Hysterectomy
Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.
Read the detailed description
Laparoscopic hysterectomy (LH) is a minimally invasive operation that could be made when vaginal hysterectomy is not accessible due to anatomical problems.
Vaginal cuff dehiscence (VCD) is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (TLH) compared with abdominal and vaginal hysterectomy.
The study shows effects of the laparoscopic approach versus the vaginal route for the management of vaginal cuff closure during total laparoscopic hysterectomy on female sexual function.
- Conditions
- Vaginal Vault Prolapse
- Being tested
- Laparoscopic and Vaginal Hysterectomy
- Keywords
- Laparoscopic hysterectomy, Vaginal hysterectomy
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic and Vaginal HysterectomyProcedure or surgery
To make a comparison between the Vaginal Vault complications after Hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Hysterectomy (Group) | Active comparator | About 28 female patients will have vaginal vault closure by vaginal approach Receives: Procedure: Laparoscopic and Vaginal Hysterectomy |
| Abdominal Laparoscopic Hysterectomy (Group) | Active comparator | About 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach Receives: Procedure: Laparoscopic and Vaginal Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative bleeding (defined as blood loss ≥500 cc)
Amount of lost blood will be measured in terms of assessment of Hemoglobin and Hematocrit levels before and after operation.
Measured: First 24 hours after The Operations
Postoperative pain
Assessment of the pain post-operatively in patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
Measured: First 24 hours after The Operations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Vault ProlapseStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ElSayed ElDesouky, Assist.Prof., Principal investigator, Al-Azhar University, Faculty of medicine for boys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960292
- Sponsor's protocol ID
- Mohamed Adel Hussien
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Vaginal Approach Closure Complications of Vaginal Vault in Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT05960292
- Acronym / sponsor ID
- Mohamed Adel Hussien
- Conditions
- Vaginal Vault Prolapse
- Keywords
- Laparoscopic hysterectomy, Vaginal hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 25 Jul 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.
Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.
Detailed description
Laparoscopic hysterectomy (LH) is a minimally invasive operation that could be made when vaginal hysterectomy is not accessible due to anatomical problems.
Vaginal cuff dehiscence (VCD) is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (TLH) compared with abdominal and vaginal hysterectomy.
The study shows effects of the laparoscopic approach versus the vaginal route for the management of vaginal cuff closure during total laparoscopic hysterectomy on female sexual function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Hysterectomy (Group) | Active comparator | Procedure: Laparoscopic and Vaginal HysterectomyAbout 28 female patients will have vaginal vault closure by vaginal approach |
| Abdominal Laparoscopic Hysterectomy (Group) | Active comparator | Procedure: Laparoscopic and Vaginal HysterectomyAbout 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who undergo laparoscopic hysterectomy
- Age ranged from 40 to 80 years.
- Patients suffering from chronic pelvic inflammatory disease (PID)
- Dysfunctional uterine bleeding
- Adenomyosis
Key exclusion criteria (1 listed)
- Patients with known 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 |
|---|---|---|
| Laparoscopic and Vaginal HysterectomyTo make a comparison between the Vaginal Vault complications after Hysterectomy | Procedure or surgery | Abdominal Laparoscopic Hysterectomy (Group), Vaginal Hysterectomy (Group) |
Primary outcome
Post operative bleeding (defined as blood loss ≥500 cc)
Time frame: First 24 hours after The Operations
Amount of lost blood will be measured in terms of assessment of Hemoglobin and Hematocrit levels before and after operation.
Postoperative pain
Time frame: First 24 hours after The Operations
Assessment of the pain post-operatively in patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
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Vaginal Vault Native Tissue Suspension
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Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
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Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
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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.
ElSayed ElDesouky, Assist.Prof. principal investigator
Al-Azhar University, Faculty of medicine for boys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic and Vaginal Hysterectomy in people with Vaginal Vault Prolapse, run by Egymedicalpedia 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 9 inclusion and 1 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 7 Sep 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 Mohamed Adel, MSC (+201065702255, elhoseeeeeeny@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative bleeding (defined as blood loss ≥500 cc) (time frame: First 24 hours after The Operations). 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 7 Sep 2023.