HysterectomyNCT03698604
Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia
A study testing Hysterectomy in people with Hysterectomy and Laparoscopy, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy, Laparoscopy
- What is being tested?
- Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Aug 2018
- 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
- The presence of perimenopausal bleeding
- Early stage endometrial carcinoma.
- Endometrial hyperplasia with/without atypia.
Who cannot join
- Obese patients i.e., BMI< 29 k.g/m2.
- Patients unfit for laparoscopy as patients with cardio-pulmonary compromise.
- Presence of adnexal mass.
- End stage endometrial carcinoma stage 3 \& 4.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia; Randomized Controlled Clinical Trial
The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia.
Read the detailed description
Research Questions:
Is total laparoscopic hysterectomy associated with similar operative operative time as total abdominal hysterectomy and bilateral salpingoophrectomy in women with uterine neoplasia?
Research Hypothesis:
In women with uterine neoplasia TLH with BSO may be similar to TAH with BSO as regard operative time.
- Conditions
- Hysterectomy, Laparoscopy
- Being tested
- Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysterectomyProcedure or surgery
Total Laparoscopic Hysterectomy Total Abdominal hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Total Laparoscopic Hysterectomy | Active comparator | The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy. Receives: Procedure: Hysterectomy |
| Total Abdominal hysterectomy | Active comparator | The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy. Receives: Procedure: Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures.
Measured: From skin incision till closure of the vault "up to 4 hours".
Secondary outcomes (6)
Blood loss
Intra operative blood loss will be estimated via:
- Amount of blood in the suction bottle.
- Estimation will be based on number of soaked gauzes and towels (soaked gauze = 20 ml blood; soaked towel = 150 ml; semi soaked towel = 75 ml).
Measured: From skin incision start until skin suturing is finished "up to 4 hours".
Blood transfusion
The need to blood transfusion to the patient.
Measured: From admission to the hospital until the home discharge "up to 1 week".
Postoperative pain
Assessment of pain intensity using Visual Analog Scale (VAS) which is one-dimensional measure of pain intensity.
It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100).
Measured: 8 hours after the end of operation.
Hospital stay
Hospital stay duration in days.
Measured: From admission to the hospital until the home discharge "up to 1 week".
Incidence of operative complications
The need for laparotomy, and bowel or bladder or ureteric injury.
Measured: During operation.
Incidence of postoperative complications
Morbidities e.g.:
- Vaginal vault hematoma or pelvic hematoma or abscess.
- Surgical site infection.
- Urinary tract infection.
- Need for post-operative blood transfusion.
- Postoperative bowel or urinary tract complications.
Measured: Up to 1 week postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jan 2018
- Primary completion1 May 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Gamal Anwar Elskaan, Ain Shams Maternity Hospital
- Investigators
- Walid E Mohammed, MD, Study director, Ain Shams Maternity HospitalMortada E Ahmed, MD, Study director, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698604
- Sponsor's protocol ID
- TLH-TAH-EN
- Status last verified
- Oct 2018
- First submitted
- 26 Sep 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia; Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03698604
- Acronym / sponsor ID
- TLH-TAH-EN
- Conditions
- Hysterectomy, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 9 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.
The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia.
Detailed description
Research Questions:
Is total laparoscopic hysterectomy associated with similar operative operative time as total abdominal hysterectomy and bilateral salpingoophrectomy in women with uterine neoplasia?
Research Hypothesis:
In women with uterine neoplasia TLH with BSO may be similar to TAH with BSO as regard operative time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Laparoscopic Hysterectomy | Active comparator | Procedure: HysterectomyThe group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy. |
| Total Abdominal hysterectomy | Active comparator | Procedure: HysterectomyThe group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The presence of perimenopausal bleeding
- Early stage endometrial carcinoma.
- Endometrial hyperplasia with/without atypia.
Key exclusion criteria (4 listed)
- Obese patients i.e., BMI< 29 k.g/m2.
- Patients unfit for laparoscopy as patients with cardio-pulmonary compromise.
- Presence of adnexal mass.
- End stage endometrial carcinoma stage 3 \& 4.
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 |
|---|---|---|
| HysterectomyTotal Laparoscopic Hysterectomy Total Abdominal hysterectomy | Procedure or surgery | Total Abdominal hysterectomy, Total Laparoscopic Hysterectomy |
Primary outcome
Operative time
Time frame: From skin incision till closure of the vault "up to 4 hours".
Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures.
6 secondary outcomes
Blood loss
Time frame: From skin incision start until skin suturing is finished "up to 4 hours".
Blood transfusion
Time frame: From admission to the hospital until the home discharge "up to 1 week".
Postoperative pain
Time frame: 8 hours after the end of operation.
Hospital stay
Time frame: From admission to the hospital until the home discharge "up to 1 week".
Incidence of operative complications
Time frame: During operation.
Incidence of postoperative complications
Time frame: Up to 1 week postoperative.
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 9 Oct 2018.
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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.
Walid E Mohammed, MD study director
Ain Shams Maternity Hospital
Mortada E Ahmed, MD study director
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysterectomy in people with Hysterectomy and Laparoscopy, run by Ain Shams Maternity Hospital 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 3 inclusion and 4 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 9 Oct 2018. 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: From skin incision till closure of the vault "up to 4 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 9 Oct 2018.