Cervical CancerNCT03069040
Nerve Sparing Radical Hysterectomy VS Radical Hysterectomy: Safety and Clinical Efficacy
A study testing nerve sparing radical hysterectomy and radical hysterectomy in people with Cervical Cancer, run by Chen Chunlin at 1 site in China.
Trial summary
Cervical cancer in young patients increased significantly in recent years, and early surgical treatment for patients with 5 years of survival rate is as high as 90%, But the traditional extensive hysterectomy (RH) caused by intraoperative pelvic autonomic nerve may damage the bladder and rectum and the incidence of… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- nerve sparing radical hysterectomy and radical hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2011to 31 Dec 2017
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical Cancer FIGO(2009) IA2,IB1,IB2,IIA1,IIA2
Who cannot join
- Cervical Cancer FIGO(2009) > IIb
- Patients received radiotherapy before opration
- The patient refused to sign a consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Randomized Controlled Trial of Nerve Sparing Hysterectomy Radical Hysterectomy and Radical Hysterectomy
Cervical cancer in young patients increased significantly in recent years, and early surgical treatment for patients with 5 years of survival rate is as high as 90%, But the traditional extensive hysterectomy (RH) caused by intraoperative pelvic autonomic nerve may damage the bladder and rectum and the incidence of complications such as sexual dysfunction is nearly 25% to 80%, thus seriously affect the patient's quality of life.Pelvic autonomic nerve preservation system of extensive hysterectomy (NSRH) can decrease the complications of above, but at home and abroad mainly adopts pulling the urine tube time, determination methods of residual urine volume, bladder function are studied in only a few scholars urine flow mechanics method is applied to carry on objective appraisal limited cases of postoperative bladder function, and the anorectal function damage ，we can use the anorectal dynamics to get objective index of anorectal function .overall research lack of large sample research of dynamic system. No objective index to evaluate the anorectal function In the early stage of the study, we have conducted about uterine ligament, sacral ligaments and nerve distribution of the bladder cervix vaginal ligament of experimental research, provide the neural anatomy basis for NSRH operation, and based on research for innovative operation scheme is put forward.Proposed on the basis of the above research, this study adopt the internationally used - urine flow mechanics, the method for evaluating the bladder function of NSRH, RH, two kinds of the injured function of bladder surgery patients before and after operation of comparative study, the change of dynamic assessment before and after surgery in patients with bladder function,and the anorectal function dameage and than provide the basis for further treatment.
- Conditions
- Cervical Cancer
- Being tested
- nerve sparing radical hysterectomy, radical hysterectomy
- Keywords
- cervical cancer, NSRH, RH, urine flow mechanics, anorectal dynamics
- 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.
nerve sparing radical hysterectomyProcedure or surgery
Also called Type C1 radical hysterectomy
Type C1 radical hysterectomy,that is nerve sparing radical hysterectomy, requires separation of two parts of the dorsal parametria: the medialpart , which entails recto -uterineandrecto-vaginal ligaments, and the lateral laminar structure, also called mesoureter, which contains the hypogastric plexus. Furthermore, type C1 requires only a partial dissection of the ureter from the ventral parametria, which is usually asymmetric towards more extensive resection of the medial leaf of the cranial (above the ureter) part of the ventral parametria .
radical hysterectomyProcedure or surgery
Also called Type C2 radical hysterectomy
In the C2 type, the ureter is completely dissected from the ventral parametria up to the urinary bladder wall. Defining the resection limits on the longitudinal (deep parametrial or vertical) plane is crucial for distinguishing between types C1 and C2.
| Study group | Role | What they receive |
|---|---|---|
| nerve-sparing radical hysterectomy | Experimental | The patient recived surgury of nerve-sparing radical hysterectomy. Receives: Procedure: nerve sparing radical hysterectomy |
| radical hysterectomy | Active comparator | The patient recived surgury of radical hysterectomy. Receives: Procedure: radical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rates
Live or die
Measured: 5 years after operation
The recurrence rate
Whether the tumor recurrence
Measured: 5 years after operation
Abdominal pressure urination
Urine flow dynamic test results
Measured: 1 years after operation
Secondary outcomes (5)
Abdominal pressure urination
Urine flow dynamic test results
Measured: 3 months after operation
Abdominal pressure urination
Urine flow dynamic test results
Measured: 6 months after operation
the results of anorectal dynamics
the results of anorectal dynamics
Measured: 1 months after opration
the results of anorectal dynamics
the results of anorectal dynamics
Measured: 3 months after opration
the results of anorectal dynamics
the results of anorectal dynamics
Measured: 6 months after opration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Nov 2011
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Chunlin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Chunlin, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069040
- Sponsor's protocol ID
- SNSRH001
- Status last verified
- Feb 2017
- First submitted
- 27 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Controlled Trial of Nerve Sparing Hysterectomy Radical Hysterectomy and Radical Hysterectomy
- ClinicalTrials.gov ID
- NCT03069040
- Acronym / sponsor ID
- SNSRH001
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, NSRH, RH, urine flow mechanics, anorectal dynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chen ChunlinUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 3 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.
Cervical cancer in young patients increased significantly in recent years, and early surgical treatment for patients with 5 years of survival rate is as high as 90%, But the traditional extensive hysterectomy (RH) caused by intraoperative pelvic autonomic nerve may damage the bladder and rectum and the incidence of complications such as sexual dysfunction is nearly 25% to 80%, thus seriously affect the patient's quality of life.Pelvic autonomic nerve preservation system of extensive hysterectomy (NSRH) can decrease the complications of above, but at home and abroad mainly adopts pulling the urine tube time, determination methods of residual urine volume, bladder function are studied in only a few scholars urine flow mechanics method is applied to carry on objective appraisal limited cases of postoperative bladder function, and the anorectal function damage ，we can use the anorectal dynamics to get objective index of anorectal function .overall research lack of large sample research of dynamic system. No objective index to evaluate the anorectal function In the early stage of the study, we have conducted about uterine ligament, sacral ligaments and nerve distribution of the bladder cervix vaginal ligament of experimental research, provide the neural anatomy basis for NSRH operation, and based on research for innovative operation scheme is put forward.Proposed on the basis of the above research, this study adopt the internationally used - urine flow mechanics, the method for evaluating the bladder function of NSRH, RH, two kinds of the injured function of bladder surgery patients before and after operation of comparative study, the change of dynamic assessment before and after surgery in patients with bladder function,and the anorectal function dameage and than provide the basis for further treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nerve-sparing radical hysterectomy | Experimental | Procedure: nerve sparing radical hysterectomyThe patient recived surgury of nerve-sparing radical hysterectomy. |
| radical hysterectomy | Active comparator | Procedure: radical hysterectomyThe patient recived surgury of radical hysterectomy. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cervical Cancer FIGO(2009) IA2,IB1,IB2,IIA1,IIA2
Key exclusion criteria (3 listed)
- Cervical Cancer FIGO(2009) > IIb
- Patients received radiotherapy before opration
- The patient refused to sign a consent form.
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 |
|---|---|---|
| nerve sparing radical hysterectomyAlso: Type C1 radical hysterectomyType C1 radical hysterectomy,that is nerve sparing radical hysterectomy, requires separation of two parts of the dorsal parametria: the medialpart , which entails recto -uterineandrecto-vaginal ligaments, and the lateral laminar structure, also called mesoureter, which contains the hypogastric plexus. Furthermore, type C1 requires only a partial dissection of the ureter from the ventral parametria, which is usually asymmetric towards more extensive resection of the medial leaf of the cranial (above the ureter) part of the ventral parametria . | Procedure or surgery | nerve-sparing radical hysterectomy |
| radical hysterectomyAlso: Type C2 radical hysterectomyIn the C2 type, the ureter is completely dissected from the ventral parametria up to the urinary bladder wall. Defining the resection limits on the longitudinal (deep parametrial or vertical) plane is crucial for distinguishing between types C1 and C2. | Procedure or surgery | radical hysterectomy |
Primary outcome
Survival rates
Time frame: 5 years after operation
Live or die
The recurrence rate
Time frame: 5 years after operation
Whether the tumor recurrence
Abdominal pressure urination
Time frame: 1 years after operation
Urine flow dynamic test results
5 secondary outcomes
Abdominal pressure urination
Time frame: 3 months after operation
Abdominal pressure urination
Time frame: 6 months after operation
the results of anorectal dynamics
Time frame: 1 months after opration
the results of anorectal dynamics
Time frame: 3 months after opration
the results of anorectal dynamics
Time frame: 6 months after opration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve sparing radical hysterectomy and radical hysterectomy in people with Cervical Cancer, run by Chen Chunlin at 1 site in China.
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 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 3 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 China. 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?
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?
Survival rates (time frame: 5 years after operation). The study lists 3 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 3 Mar 2017.