Effect of Learning Curve on Operative Time in TLH and Comparing it to TAHNCT03407846
Total Laparoscopic Hystrectomy Versus Total Abdominal Hystrectomy
A study testing Hystrectomy in people with Effect of Learning Curve on Operative Time in TLH and Comparing it to TAH, run by Ain Shams University at 1 site in Egypt.
Trial summary
100 patient will be recruited for hystrectomy for benign cause and TLH will be copared to TAH and effect of learning curve will be assessed by comparing operative time between early and lat patients in TLH group Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Learning Curve on Operative Time in TLH and Comparing it to TAH
- What is being tested?
- Hystrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jul 2016to 22 Sep 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age. More than 40 Uterine size less than 14 weeks No contraindications for laparscopic surgery Benign cause for hystrectomy
Who cannot join
- virgins Malignancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo, 22222
Mohammed Dr Abdelfattah, Lecturer, 01005355324, Abdel_mohsen@live.com
Ahmed Mohsen, lecturer, 01069991411, M.elsenity@yahoo.com
About this study
Official title: Total Laparoscopic Hystrectomy Versus Total Abdominal Hystrectomy: the Effect of Learning Curve a Randomized Controlled Trial
100 patient will be recruited for hystrectomy for benign cause and TLH will be copared to TAH and effect of learning curve will be assessed by comparing operative time between early and lat patients in TLH group
- Being tested
- Hystrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HystrectomyProcedure or surgery
Total laparscopic hystrectomy versus total abdominal hystrectomy
| Study group | Role | What they receive |
|---|---|---|
| Total laparscopic hystrectomy | Active comparator | Not described Receives: Procedure: Hystrectomy |
| Total abdominal hystrectomy | Experimental | Not described Receives: Procedure: Hystrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Time in both type of hystrectomy will be compared and learning curve will be assesd among TLH group by comparing early cases to late
Measured: 2 years
Secondary outcomes (1)
Blood loss, coplications, postoperative pain
Hb measurment , and visual scale for pain
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start22 Jul 2016
- Primary completion1 Sep 2018 (estimated)
- Study completion22 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Learning Curve on Operative Time in TLH and Comparing it to TAHStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed abd elfatah elsenity, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407846
- Sponsor's protocol ID
- Total laparoscopic hystrectomy
- Status last verified
- Mar 2018
- First submitted
- 20 Sep 2017
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Kept with researcher as cds for patients
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Laparoscopic Hystrectomy Versus Total Abdominal Hystrectomy: the Effect of Learning Curve a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03407846
- Acronym / sponsor ID
- Total laparoscopic hystrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 22 Sep 2018 (estimated)
- First posted
- 23 Jan 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.
100 patient will be recruited for hystrectomy for benign cause and TLH will be copared to TAH and effect of learning curve will be assessed by comparing operative time between early and lat patients in TLH group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total laparscopic hystrectomy | Active comparator | Procedure: Hystrectomy |
| Total abdominal hystrectomy | Experimental | Procedure: Hystrectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age. More than 40 Uterine size less than 14 weeks No contraindications for laparscopic surgery Benign cause for hystrectomy
Key exclusion criteria (1 listed)
- virgins 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 |
|---|---|---|
| HystrectomyTotal laparscopic hystrectomy versus total abdominal hystrectomy | Procedure or surgery | Total abdominal hystrectomy, Total laparscopic hystrectomy |
Primary outcome
Operative time
Time frame: 2 years
Time in both type of hystrectomy will be compared and learning curve will be assesd among TLH group by comparing early cases to late
1 secondary outcome
Blood loss, coplications, postoperative pain
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Individual participant dataSharing planned: Yes. Kept with researcher as cds for patients
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hystrectomy in people with Effect of Learning Curve on Operative Time in TLH and Comparing it to TAH, 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 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 12 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: 2 years). 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 12 Mar 2018.