Benign Gynecological DiseaseNCT03692832
Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease
A study testing LH and VH in people with Benign Gynecological Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study is designed to compare laparoscopic and vaginal hysterectomy in women with benign gynaecological disease in Ain Shams University Maternity Hospital. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Benign Gynecological Disease
- What is being tested?
- LH and VH
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Mar 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women undergoing hysterectomy for benign gynaecological disease (e.g., dysfunctional uterine bleeding, adenomyosis, fibroids).
Who cannot join
- known tubo-ovarian pathology requiring primary laparotomy, e.g. large adnexal masses
- known neoplasia requiring pelvic lymphadenectomy
- pelvic organ prolapse requiring additional procedures, e.g., uterine procidentia (complete prolapse), enterocoele
- conditions interfering with laparoscopic surgery, e.g. cardio-pulmonary disease, obesity (BMI 30 kg/m2 or more)
- large uteri interfering with vaginal hysterectomy (size >16 gestational weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Versus Vaginal Hysterectomy for Benign Gynaecological Disease in Ain Shams University Maternity Hospital: A Randomized Clinical Trial
This study is designed to compare laparoscopic and vaginal hysterectomy in women with benign gynaecological disease in Ain Shams University Maternity Hospital.
Read the detailed description
The current trial evaluates the performance and short-term postoperative outcomes of these two approaches for hysterectomy in Ain Shams University Maternity Hospital, a major tertiary hospital in Greater Cairo, and one of Egypt's leading centers in terms of provision of public medical service.
Eighty patients with benign indications, with no contraindications to neither laparoscopic nor vaginal approaches, were randomized into two equal groups, to undergo either of the two procedures: LH or VH.
- Conditions
- Benign Gynecological Disease
- Being tested
- LH, VH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHProcedure or surgery
Laparoscopic hysterectomy following AAGL class IV E, vault closed vaginally
VHProcedure or surgery
Vaginal hysterectomy following Heaney technique
| Study group | Role | What they receive |
|---|---|---|
| Group L | Experimental | 40 patients undergoing laparoscopic hysterectomy Receives: Procedure: LH |
| Group V | Active comparator | 40 patients undergoing vaginal hysterectomy Receives: Procedure: VH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Total operative time (minutes) for LH versus VH; from introduction of the first laparoscopy port or vaginal incision, till suturing the vaginal vault.
Measured: duration of surgical procedure
Secondary outcomes (9)
Blood loss
Blood loss (mL): by measuring suctioned blood (subtracting irrigation volumes), Weighing sponges (weight difference of soaked and dry surgical gauzes, 1 g ≃ 1 mL), or according to Gross (1983) formula (mL)
Measured: intra-operative
Blood transfusion
Need for blood transfusion
Measured: 24 hours post-operative
Proportion of successful vaginal opportunistic salpingectomy
Proportion of patients with successful vaginal opportunistic salpingectomy or salpingo-oophorectomy compared to laparoscopic approach, and factors for non completion
Measured: intra-operative
Surgical complications
Surgical complications: visceral or vascular injuries, vaginal cuff haematoma or dehiscence
Measured: intra-operative
Post-operative pain assessed using visual analogue scale for pain intensity
Post-operative pain: assessed using visual analogue scale for pain intensity at 2, 6 and 24 hours post-operative
Measured: first 24 hours post-operative
Febrile morbidity
Post-operative fever (temperature assessed in degrees Celsius)
Measured: first 24 hours post-operative
Change in serum markers for inflammation
Inflammatory response serum markers compared pre- and 24-h postoperatively (e.g. C-reactive protein or interleukin-6 according to availability)
Measured: first 24 hours post-operative
Hospital-stay
Post-operative hospital-stay (hours)
Measured: 1 week
Healthcare costs
Healthcare costs (EGP), including consumables, medications, and admission fees.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Gynecological DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdy Bakry Alqenawy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692832
- Sponsor's protocol ID
- LH-VH
- Status last verified
- Dec 2021
- First submitted
- 10 Sep 2018
- Last updated
- 14 Jan 2022
- 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Vaginal Hysterectomy for Benign Gynaecological Disease in Ain Shams University Maternity Hospital: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03692832
- Acronym / sponsor ID
- LH-VH
- Conditions
- Benign Gynecological Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 2 Oct 2018 (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 study is designed to compare laparoscopic and vaginal hysterectomy in women with benign gynaecological disease in Ain Shams University Maternity Hospital.
Detailed description
The current trial evaluates the performance and short-term postoperative outcomes of these two approaches for hysterectomy in Ain Shams University Maternity Hospital, a major tertiary hospital in Greater Cairo, and one of Egypt's leading centers in terms of provision of public medical service.
Eighty patients with benign indications, with no contraindications to neither laparoscopic nor vaginal approaches, were randomized into two equal groups, to undergo either of the two procedures: LH or VH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Experimental | Procedure: LH40 patients undergoing laparoscopic hysterectomy |
| Group V | Active comparator | Procedure: VH40 patients undergoing vaginal hysterectomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing hysterectomy for benign gynaecological disease (e.g., dysfunctional uterine bleeding, adenomyosis, fibroids).
Key exclusion criteria (5 listed)
- known tubo-ovarian pathology requiring primary laparotomy, e.g. large adnexal masses
- known neoplasia requiring pelvic lymphadenectomy
- pelvic organ prolapse requiring additional procedures, e.g., uterine procidentia (complete prolapse), enterocoele
- conditions interfering with laparoscopic surgery, e.g. cardio-pulmonary disease, obesity (BMI 30 kg/m2 or more)
- large uteri interfering with vaginal hysterectomy (size >16 gestational weeks)
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 |
|---|---|---|
| LHLaparoscopic hysterectomy following AAGL class IV E, vault closed vaginally | Procedure or surgery | Group L |
| VHVaginal hysterectomy following Heaney technique | Procedure or surgery | Group V |
Primary outcome
Operative time
Time frame: duration of surgical procedure
Total operative time (minutes) for LH versus VH; from introduction of the first laparoscopy port or vaginal incision, till suturing the vaginal vault.
9 secondary outcomes
Blood loss
Time frame: intra-operative
Blood transfusion
Time frame: 24 hours post-operative
Proportion of successful vaginal opportunistic salpingectomy
Time frame: intra-operative
Surgical complications
Time frame: intra-operative
Post-operative pain assessed using visual analogue scale for pain intensity
Time frame: first 24 hours post-operative
Febrile morbidity
Time frame: first 24 hours post-operative
Change in serum markers for inflammation
Time frame: first 24 hours post-operative
Hospital-stay
Time frame: 1 week
Healthcare costs
Time frame: 1 week
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 14 Jan 2022.
Related trials for Benign Gynecological Disease
Recruiting
vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications
Hysterectomy, Benign Uterine Diseases
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Recruiting
Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy
Leiomyoma, Uterine, Benign Gynecological Disease
Recruiting
Impact of Time on Sexual Function (FSFI® Score) After Hysterectomy
Time Between Hysterectomy and Resumption of Sexual Relations, Sexual Function
Active, not recruitingObservational study
The Learning Curve of a Gynecology and Obstetrics Resident Performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) Hysterectomy in a University Hospital
Abnormal Uterine Bleeding, Unspecified, Benign Gynecological Disease
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 LH and VH in people with Benign Gynecological Disease, 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 1 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 14 Jan 2022. 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: duration of surgical procedure). 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 14 Jan 2022.