Renal DiseaseNCT02398110
Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy
A study testing transvaginal NOTES nephrectomy and conventional laparoscopic nephrectomy in people with Renal Disease, run by First Affiliated Hospital of Gannan Medical University at 1 site in China.
Trial summary
Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet comparative studies are lacking. The aim of this study was to compare the surgical outcomes of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Renal Disease
- What is being tested?
- transvaginal NOTES nephrectomy and conventional laparoscopic nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female sex,
- indication for nephrectomy due to benign or malignant kidney disease,
- age between 18 and 65 years, and
- legal competence
Who cannot join
- emergency surgery,
- contraindications to laparoscopic surgery,
- class IV or V as defined by the American Society for Anesthesiologists (ASA),
- body mass index (BMI) of > 30 kg/m2,
- advanced TNM staging (≥ T3),
- history of major abdominal surgery,
- gravidity or breast-feeding, and
- no written informed consent signed
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000
Xiaofeng Zou, MD, +86-797-8269588, gyfyurology@126.com
About this study
Official title: Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy: a Randomized Clinical Trial
Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet comparative studies are lacking. The aim of this study was to compare the surgical outcomes of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy.
- Conditions
- Renal Disease
- Being tested
- transvaginal NOTES nephrectomy, conventional laparoscopic nephrectomy
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal NOTES nephrectomyProcedure or surgery
A 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus. A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity
conventional laparoscopic nephrectomyProcedure or surgery
One 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin
| Study group | Role | What they receive |
|---|---|---|
| transvaginal NOTES nephrectomy | Experimental | A 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus. A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity Receives: Procedure: transvaginal NOTES nephrectomy; Procedure: conventional laparoscopic nephrectomy |
| conventional laparoscopic nephrectomy | Active comparator | One 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin Receives: Procedure: transvaginal NOTES nephrectomy; Procedure: conventional laparoscopic nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10)
Pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 1
Secondary outcomes (6)
Cosmetic assessment (Patient Scar Assessment Questionnaire)
The cosmetic result was assessed using a Patient Scar Assessment Questionnaire and Scoring System (PSAQ)
Measured: > 3 months after surgery
Sexual function (Female Sexual Function Index)
Sexual function was evaluated according to the Female Sexual Function Index
Measured: Preoperatively, and 4, 8 and 12 months postoperatively
Intraoperative complications (e.g. bleeding, organ-injury)
e.g. bleeding, organ-injury
Measured: Evaluated at the operation day
Duration of the operation
in minutes
Measured: at the operation day
Quality of life (SF-36)
measured with the
Measured: on postoperative month 1
Postoperative complication (classified using the Clavien-Dindo system)
Early (≤ 1 month) and late (> 1 month) complications were classified using the Clavien-Dindo system
Measured: early (≤ 1 month), or late (>1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Gannan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng Zou, First Affiliated Hospital of Gannan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398110
- Sponsor's protocol ID
- 20121BBG70032
- Status last verified
- Aug 2015
- First submitted
- 10 Mar 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02398110
- Acronym / sponsor ID
- 20121BBG70032
- Conditions
- Renal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Gannan Medical UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 25 Mar 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.
Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet comparative studies are lacking. The aim of this study was to compare the surgical outcomes of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transvaginal NOTES nephrectomy | Experimental | Procedure: transvaginal NOTES nephrectomy, Procedure: conventional laparoscopic nephrectomyA 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus. A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity |
| conventional laparoscopic nephrectomy | Active comparator | Procedure: transvaginal NOTES nephrectomy, Procedure: conventional laparoscopic nephrectomyOne 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female sex,
- indication for nephrectomy due to benign or malignant kidney disease,
- age between 18 and 65 years, and
- legal competence
Key exclusion criteria (8 listed)
- emergency surgery,
- contraindications to laparoscopic surgery,
- class IV or V as defined by the American Society for Anesthesiologists (ASA),
- body mass index (BMI) of > 30 kg/m2,
- advanced TNM staging (≥ T3),
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 |
|---|---|---|
| transvaginal NOTES nephrectomyA 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus. A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity | Procedure or surgery | conventional laparoscopic nephrectomy, transvaginal NOTES nephrectomy |
| conventional laparoscopic nephrectomyOne 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin | Procedure or surgery | conventional laparoscopic nephrectomy, transvaginal NOTES nephrectomy |
Primary outcome
Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 1
Pain Scores on the Visual Analog Scale (0-10)
6 secondary outcomes
Cosmetic assessment (Patient Scar Assessment Questionnaire)
Time frame: > 3 months after surgery
Sexual function (Female Sexual Function Index)
Time frame: Preoperatively, and 4, 8 and 12 months postoperatively
Intraoperative complications (e.g. bleeding, organ-injury)
Time frame: Evaluated at the operation day
Duration of the operation
Time frame: at the operation day
Quality of life (SF-36)
Time frame: on postoperative month 1
Postoperative complication (classified using the Clavien-Dindo system)
Time frame: early (≤ 1 month), or late (>1 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transvaginal NOTES nephrectomy and conventional laparoscopic nephrectomy in people with Renal Disease, run by First Affiliated Hospital of Gannan Medical University 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 4 inclusion and 8 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 13 Aug 2015. 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?
Contact Xiaofeng Zou, MD (+86-797-8269588, gyfyurology@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10) (time frame: at postoperative day 1). 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 13 Aug 2015.