Cervical CancerNCT02524756
Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy
A study testing laparoscopic nerve-sparing radical hysterectomy-type III/C1 and laparoscopic radical hysterectomy (type III/C2). in people with Cervical Cancer, run by Osama Mohammad Ali ElDamshety at 2 sites in 2 countries.
Trial summary
The aim of this study is to assess: 1. Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time. 2. Evaluate patients' outcome as regard bladder function. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- laparoscopic nerve-sparing radical hysterectomy-type III/C1 and laparoscopic radical hysterectomy (type III/C2).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2014to Nov 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Karnofsky > 80, or American Society of anaethesiology (ASA) I-II
- Stage IA2-IB1-IB2-IIA1-IIA2-IIB cervical cancer according to FIGO (International Federation of Gynecology and Obstetrics) staging.
- Stage II, III endometrial cancer
Who cannot join
- Non Invasive Cancer
- Pregnancy
- Bladder dysfunction detected prior to surgery.
- Previous pelvic lymphadenectomy.
- Tumour recurrence
- Incomplete surgery, unresectable lesion.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The aim of this study is to assess:
- Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time.
- Evaluate patients' outcome as regard bladder function. in order to preserve the function of the bladder and the rectum, it is necessary to modify the traditional procedures, so as to identify the precise anatomical information directing the technique for optimal preservation of bladder function at the time of radical hysterectomy.
Read more
The laparoscopic technique offers several well-known advantages. Under the magnified view of the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and precise dissection of the para-cervical structures and areolar tissue, including the blood vessels and the nerves.
Laparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as this qualification could prohibit long-term bladder and voiding dysfunction during nerve-sparing radical hysterectomy
- Conditions
- Cervical Cancer
- Being tested
- laparoscopic nerve-sparing radical hysterectomy-type III/C1, laparoscopic radical hysterectomy (type III/C2).
- Keywords
- nerve sparing radical hysterectomy
- 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.
laparoscopic nerve-sparing radical hysterectomy-type III/C1Procedure or surgery
laparoscopic radical hysterectomy (type III/C2).Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Active comparator | laparoscopic nerve sparing radical hysterectomy type III/C1 Receives: Procedure: laparoscopic nerve-sparing radical hysterectomy-type III/C1 |
| Group (B) | Active comparator | laparoscopic radical hysterectomy type III/C2 Receives: Procedure: laparoscopic radical hysterectomy (type III/C2). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1
Duration of postoperative catheterization untill PVR urine volume is less than 100 ml
Measured: 1 month
Secondary outcomes (6)
Intraoperative complications
intraoperative complications
Measured: During Surgery
Blood loss
Amount of blood intraoperative blood loss in ml. units
Measured: Day of surgery
Operative time
Minutes for the surgical intervention
Measured: Day of surgery
Early postoperative complication
Occurence of early postoperative complication within 30 days of operation
Measured: 30 days
Late postoperative complication
complications related to surgery more than 30 days postoperative
Measured: more than 30 days postoperative
Bladder training exercise
Removal of urinary catheter on the 3rd day postoperative without prior bladder training exercise and measurement of PVR urine volume
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 posted17 Aug 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osama Mohammad Ali ElDamshety
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Responsible party
- Sponsor-investigator, Osama Mohammad Ali ElDamshety, Mansoura University
- Investigators
- Khaled Gaballa, MS.c., Principal investigator, Assistant Lecturer of surgical oncology, Mansoura universitryAdel Taha Denewar, M.D., Ph.D, Study chair, Head of surgical oncology department, Mansoura oncology centre, Mansoura universityGiovanni Scambia, M.D.,Ph.D, Study director, Head of the Department for Woman and Unborn Life Health Care- Catholic University of the Sacred Heart- Rome, ItalyValerio Gallotta, M.D., Study director, Department of Gynecologic Oncology,Catholic University of the Sacred Heart,Rome,Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524756
- Sponsor's protocol ID
- LNS-RH
- Status last verified
- Mar 2018
- First submitted
- 12 Aug 2015
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy
- ClinicalTrials.gov ID
- NCT02524756
- Acronym / sponsor ID
- LNS-RH
- Conditions
- Cervical Cancer
- Keywords
- nerve sparing radical hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Osama Mohammad Ali ElDamshetyUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Aug 2015 (estimated)
- 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 assess:
- Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time.
- Evaluate patients' outcome as regard bladder function. in order to preserve the function of the bladder and the rectum, it is necessary to modify the traditional procedures, so as to identify the precise anatomical information directing the technique for optimal preservation of bladder function at the time of radical hysterectomy.
The laparoscopic technique offers several well-known advantages. Under the magnified view of the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and precise dissection of the para-cervical structures and areolar tissue, including the blood vessels and the nerves.
Laparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as this qualification could prohibit long-term bladder and voiding dysfunction during nerve-sparing radical hysterectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Procedure: laparoscopic nerve-sparing radical hysterectomy-type III/C1laparoscopic nerve sparing radical hysterectomy type III/C1 |
| Group (B) | Active comparator | Procedure: laparoscopic radical hysterectomy (type III/C2).laparoscopic radical hysterectomy type III/C2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years.
- Karnofsky > 80, or American Society of anaethesiology (ASA) I-II
- Stage IA2-IB1-IB2-IIA1-IIA2-IIB cervical cancer according to FIGO (International Federation of Gynecology and Obstetrics) staging.
- Stage II, III endometrial cancer
Key exclusion criteria (6 listed)
- Non Invasive Cancer
- Pregnancy
- Bladder dysfunction detected prior to surgery.
- Previous pelvic lymphadenectomy.
- Tumour recurrence
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 |
|---|---|---|
| laparoscopic nerve-sparing radical hysterectomy-type III/C1 | Procedure or surgery | Group (A) |
| laparoscopic radical hysterectomy (type III/C2). | Procedure or surgery | Group (B) |
Primary outcome
Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1
Time frame: 1 month
Duration of postoperative catheterization untill PVR urine volume is less than 100 ml
6 secondary outcomes
Intraoperative complications
Time frame: During Surgery
Blood loss
Time frame: Day of surgery
Operative time
Time frame: Day of surgery
Early postoperative complication
Time frame: 30 days
Late postoperative complication
Time frame: more than 30 days postoperative
Bladder training exercise
Time frame: 1 month
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 6 Mar 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.
Khaled Gaballa, MS.c. principal investigator
Assistant Lecturer of surgical oncology, Mansoura universitry
Adel Taha Denewar, M.D., Ph.D study chair
Head of surgical oncology department, Mansoura oncology centre, Mansoura university
Giovanni Scambia, M.D.,Ph.D study director
Head of the Department for Woman and Unborn Life Health Care- Catholic University of the Sacred Heart- Rome, Italy
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic nerve-sparing radical hysterectomy-type III/C1 and laparoscopic radical hysterectomy (type III/C2). in people with Cervical Cancer, run by Osama Mohammad Ali ElDamshety at 2 sites in 2 countries.
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 4 inclusion and 6 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 6 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 2 sites in Egypt, Italy. 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?
Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1 (time frame: 1 month). 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 6 Mar 2018.