Malignant Neoplasm of Cervix, Endometrium and OvaryNCT03096652
A Modified Approach for Morbid Obese With Gynecologic Cancer
A study testing Approach for cancer resection in people with Malignant Neoplasm of Cervix, Endometrium and Ovary, run by Mansoura University at 1 site in Egypt.
Trial summary
Comparing standard midline approach with the modified approach in management of morbid obese patients with gynecologic cancers. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Malignant Neoplasm of Cervix, Endometrium and Ovary
- What is being tested?
- Approach for cancer resection
- 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
- Aug 2016to Dec 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
- Resectable (ovarian, endometrial, cervical) cancers.
- Anaesthetically fit (ASA 1 and 2).
- Abdominal pannus below symphysis pubis.
Who cannot join
- Non resectable gynecologic cancer.
- Unfit patients.
- Patients who refuse to share in the trial.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Oncology center Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Islam H Metwally, MSc, MRCS, 01002985865 ext. 020, drislamhany@mans.edu.eg
Ahmed AbdAllah, MD
About this study
Official title: Gynecologic Cancer: a Modified Approach for Morbid Obese Patients
Comparing standard midline approach with the modified approach in management of morbid obese patients with gynecologic cancers.
- Being tested
- Approach for cancer resection
- Keywords
- gynecologic cancer - panniculectomy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approach for cancer resectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Midline approach | Active comparator | Standard midline incision, then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy). Receives: Procedure: Approach for cancer resection |
| Modified approach | Active comparator | Panniculectomy with vertical incision of the rectus sheath then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy). Receives: Procedure: Approach for cancer resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncologic outcome
measured by number of lymph nodes retrieved and rate of optimal debulking.
Measured: 2 weeks
Secondary outcomes (4)
Operative time
Measured: 1 day
Postoperative procedure related morbidity
Wound and chest complications
Measured: 1 month
Blood loss
intraoperative
Measured: 1 day
Hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of Cervix, Endometrium and OvaryStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Hany Metwally, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096652
- Sponsor's protocol ID
- R/16.06.54
- Status last verified
- Aug 2016
- First submitted
- 22 Mar 2017
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynecologic Cancer: a Modified Approach for Morbid Obese Patients
- ClinicalTrials.gov ID
- NCT03096652
- Acronym / sponsor ID
- R/16.06.54
- Keywords
- gynecologic cancer - panniculectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 30 Mar 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.
Comparing standard midline approach with the modified approach in management of morbid obese patients with gynecologic cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midline approach | Active comparator | Procedure: Approach for cancer resectionStandard midline incision, then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy). |
| Modified approach | Active comparator | Procedure: Approach for cancer resectionPanniculectomy with vertical incision of the rectus sheath then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Resectable (ovarian, endometrial, cervical) cancers.
- Anaesthetically fit (ASA 1 and 2).
- Abdominal pannus below symphysis pubis.
Key exclusion criteria (3 listed)
- Non resectable gynecologic cancer.
- Unfit patients.
- Patients who refuse to share in the trial.
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 |
|---|---|---|
| Approach for cancer resection | Procedure or surgery | Midline approach, Modified approach |
Primary outcome
Oncologic outcome
Time frame: 2 weeks
measured by number of lymph nodes retrieved and rate of optimal debulking.
4 secondary outcomes
Operative time
Time frame: 1 day
Postoperative procedure related morbidity
Time frame: 1 month
Blood loss
Time frame: 1 day
Hospital stay
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Individual participant dataSharing planned: No
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 Approach for cancer resection in people with Malignant Neoplasm of Cervix, Endometrium and Ovary, 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: status not confirmed, as of the sponsor's last update on 30 Mar 2017. 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?
Contact Islam H Metwally, MSc, MRCS (01002985865 ext. 020, drislamhany@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncologic outcome (time frame: 2 weeks). 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 Mar 2017.