HysteromyomaNCT03251677
Total Laparoscopic Hysterectomy vs Minilap Hysterectomy
A study testing Surgical procedure, Hysterectomy in people with Hysteromyoma, run by Mansoura University at 1 site in Egypt.
Trial summary
The objective of this study is to compare the perioperative outcomes between mini-lap hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysteromyoma
- What is being tested?
- Surgical procedure, Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Mar 2019
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mobile uterus.
- Uterine size up to 12 weeks gestation.
- Benign lesions.
Who cannot join
- Enlarged uterus > 12 weeks gestation.
- Suspected malignancy.
- Large adnexal masses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study Comparing Total Laparoscopic Hysterectomy (Lap Hysterectomy) vs Minilaparotomy (Mini-lap Hysterectomy) for Benign Uterine Lesions: Peri-operative Outcome
The objective of this study is to compare the perioperative outcomes between mini-lap hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.
Read the detailed description
A prospective randomized open-label study was conducted. Women >18 years of age undergoing TLH because of benign indications were recruited. Patients were randomized for either TLH (Group I, 40 cases) or minilap hysterectomy (Group II, 40 cases) through 4-5cm abdominal Pfannenstiel incision.
Inclusion criteria were mobile uterus with benign lesion and with a size up to 12 weeks gestation. Exclusion criteria adopted were patients with enlarged uterus < 12 weeks, suspected malignancy and large adnexal masses (>5cm). Peri-operative outcomes were compared.
Written informed consent was obtained from all the patients and the Departmental Ethical Committee approved the study. Patients from OB/GYN Mansoura University Hospital were enrolled. All the operations were performed by at least one of the consultants included as authors in this study.
- Conditions
- Hysteromyoma
- Being tested
- Surgical procedure, Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical procedure, HysterectomyProcedure or surgery
Surgical removal of the uterus
| Study group | Role | What they receive |
|---|---|---|
| Total laparo hysterectomy | Active comparator | Surgical procedure, Hysterectomy (removal of the uterus by laparoscopy) Receives: Procedure: Surgical procedure, Hysterectomy |
| Mini-lap hysterectomy | Active comparator | Surgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy) Receives: Procedure: Surgical procedure, Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time (min)
Time in minutes taken for total hysterectomy
Measured: Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)
Estimated blood loss (mL)
Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values
Measured: Through surgical intervention completion
Secondary outcomes (1)
Early postoperative complications
Related complications
Measured: Within 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Sep 2017
- Primary completion1 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteromyomaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Shokeir, Mansoura University
- Investigators
- Tarek Shokeir, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251677
- Sponsor's protocol ID
- MD/16.12.51
- Status last verified
- Sep 2019
- First submitted
- 10 Aug 2017
- Last updated
- 30 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing up to scientific publication of a manuscript
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Comparing Total Laparoscopic Hysterectomy (Lap Hysterectomy) vs Minilaparotomy (Mini-lap Hysterectomy) for Benign Uterine Lesions: Peri-operative Outcome
- ClinicalTrials.gov ID
- NCT03251677
- Acronym / sponsor ID
- MD/16.12.51
- Conditions
- Hysteromyoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 16 Aug 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.
The objective of this study is to compare the perioperative outcomes between mini-lap hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.
Detailed description
A prospective randomized open-label study was conducted. Women >18 years of age undergoing TLH because of benign indications were recruited. Patients were randomized for either TLH (Group I, 40 cases) or minilap hysterectomy (Group II, 40 cases) through 4-5cm abdominal Pfannenstiel incision.
Inclusion criteria were mobile uterus with benign lesion and with a size up to 12 weeks gestation. Exclusion criteria adopted were patients with enlarged uterus < 12 weeks, suspected malignancy and large adnexal masses (>5cm). Peri-operative outcomes were compared.
Written informed consent was obtained from all the patients and the Departmental Ethical Committee approved the study. Patients from OB/GYN Mansoura University Hospital were enrolled. All the operations were performed by at least one of the consultants included as authors in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total laparo hysterectomy | Active comparator | Procedure: Surgical procedure, HysterectomySurgical procedure, Hysterectomy (removal of the uterus by laparoscopy) |
| Mini-lap hysterectomy | Active comparator | Procedure: Surgical procedure, HysterectomySurgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mobile uterus.
- Uterine size up to 12 weeks gestation.
- Benign lesions.
Key exclusion criteria (3 listed)
- Enlarged uterus > 12 weeks gestation.
- Suspected malignancy.
- Large adnexal masses.
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 |
|---|---|---|
| Surgical procedure, HysterectomySurgical removal of the uterus | Procedure or surgery | Mini-lap hysterectomy, Total laparo hysterectomy |
Primary outcome
Operative Time (min)
Time frame: Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)
Time in minutes taken for total hysterectomy
Estimated blood loss (mL)
Time frame: Through surgical intervention completion
Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values
1 secondary outcome
Early postoperative complications
Time frame: Within 30 days after operation
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 30 Sep 2019.
- Individual participant dataSharing planned: Yes. Sharing up to scientific publication of a manuscript
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.
Tarek Shokeir principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical procedure, Hysterectomy in people with Hysteromyoma, run by Mansoura 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 3 inclusion and 3 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 30 Sep 2019. 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 (min) (time frame: Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)). 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 30 Sep 2019.