Laparoscopic HysterectomyNCT03144414
Laparoscopic Assisted Doderlin Vaginal Hysterectomy
A study testing Laparoscopic hysterectomy in people with Laparoscopic Hysterectomy, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective randomized clinical trial will be conducted in Ain Shams University Maternity Hospital during the period from May 2017 to December 2017. Group Ι: 30 patients will undergo conventional laparoscopic assisted vaginal hysterectomy (LAVH). Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- Laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2017to 20 Jan 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 40 years.
- Uterine size ≤ 14weeks.
- Benign uterine pathology (Fibroid uterus, endometrial hyperplasia, DUB, uterine prolapse).
- No contraindication for laparoscopic surgery.
Who cannot join
- Gynecologic malignancy.
- Contraindications to laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
- Large abdominal hernia
- Large ovarian mass
- History of previous laparotomy finding extensive adhesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Assisted Doderlin Vaginal Hysterectomy vs. Laparoscopic Assisted Vaginal Hysterectomy: A Randomized Clinical Trial.
This prospective randomized clinical trial will be conducted in Ain Shams University Maternity Hospital during the period from May 2017 to December 2017. Group Ι: 30 patients will undergo conventional laparoscopic assisted vaginal hysterectomy (LAVH). Group ΙΙ: 30 patients will undergo laparoscopic assisted Doderlein vaginal hysterectomy (LADH)
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- Laparoscopic hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic hysterectomyProcedure or surgery
Also called Laparoscopic Assisted Hysterectomy
Laparoscopic hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| LAVH | Active comparator | Laparoscopic Assisted Vaginal Hysterectomy Receives: Procedure: Laparoscopic hysterectomy |
| LADH | Active comparator | Laparoscopic Assisted Doderlin Vaginal Hysterectomy Receives: Procedure: Laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Measured: 24 hours
Secondary outcomes (4)
postoperative pain
questionnaire using Visual Analogue scale
Measured: 24 hours
operative complications
Measured: 24 hours
Hospital stay
Measured: 24 hours
Blood loss
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start20 May 2017
- Primary completion10 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144414
- Sponsor's protocol ID
- AS1393
- Status last verified
- Jan 2020
- First submitted
- 30 Apr 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Assisted Doderlin Vaginal Hysterectomy vs. Laparoscopic Assisted Vaginal Hysterectomy: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03144414
- Acronym / sponsor ID
- AS1393
- Conditions
- Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 8 May 2017 (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.
This prospective randomized clinical trial will be conducted in Ain Shams University Maternity Hospital during the period from May 2017 to December 2017. Group Ι: 30 patients will undergo conventional laparoscopic assisted vaginal hysterectomy (LAVH). Group ΙΙ: 30 patients will undergo laparoscopic assisted Doderlein vaginal hysterectomy (LADH)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAVH | Active comparator | Procedure: Laparoscopic hysterectomyLaparoscopic Assisted Vaginal Hysterectomy |
| LADH | Active comparator | Procedure: Laparoscopic hysterectomyLaparoscopic Assisted Doderlin Vaginal Hysterectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 40 years.
- Uterine size ≤ 14weeks.
- Benign uterine pathology (Fibroid uterus, endometrial hyperplasia, DUB, uterine prolapse).
- No contraindication for laparoscopic surgery.
Key exclusion criteria (5 listed)
- Gynecologic malignancy.
- Contraindications to laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
- Large abdominal hernia
- Large ovarian mass
- History of previous laparotomy finding extensive adhesions
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 hysterectomyAlso: Laparoscopic Assisted HysterectomyLaparoscopic hysterectomy | Procedure or surgery | LADH, LAVH |
Primary outcome
Operative time
Time frame: 24 hours
4 secondary outcomes
postoperative pain
Time frame: 24 hours
operative complications
Time frame: 24 hours
Hospital stay
Time frame: 24 hours
Blood loss
Time frame: 24 hours
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 28 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 hysterectomy in people with Laparoscopic Hysterectomy, run by Ain Shams 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 4 inclusion and 5 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 28 Jan 2020. 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?
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?
Operative time (time frame: 24 hours). 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 28 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.