Stomach NeoplasmsNCT02327481
Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer
A study testing 3D Laparoscopic Surgery and 2D Laparoscopic Surgery in people with Stomach Neoplasms, run by Fujian Medical University.
Trial summary
The purpose of this study is to explore the feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- 3D Laparoscopic Surgery and 2D Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 26 Apr 2021
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)Age from over 19 to under 74 years
- (2)cT1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- (3)Heart, lungs, kidneys, and other vital organs function well, with no obvious surgical contraindications
- (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around the main abdominal artery, and tumor not a direct violation of the pancreas, spleen, and other surrounding organs
- (5)American Society of Anesthesiology (ASA) score class I, II, or III
- (6)Written informed consent
Who cannot join
- (1)Women during pregnancy or breast-feeding
- (2)Severe mental disorder
- (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels
- (5)History of unstable angina or myocardial infarction within the past six months
- (6)History of cerebrovascular accident within the past six months
Show all 11Show fewer
- (7)History of continuous systematic administration of corticosteroids within one month
- (8)History of previous neoadjuvant chemotherapy or radiotherapy
- (9)T4b tumors
- (10)Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer
- (11)FEV1(Forced expiratory volume in one second)<50% of predicted values
About this study
The purpose of this study is to explore the feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied.
Read the detailed description
A prospective randomized comparison of 3D and 2D laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 3D laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year/5-year survival and recurrence rates.
- Conditions
- Stomach Neoplasms
- Being tested
- 3D Laparoscopic Surgery, 2D Laparoscopic Surgery
- Keywords
- Stomach Neoplasms Laparoscopy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Laparoscopic SurgeryProcedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 3D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
2D Laparoscopic SurgeryProcedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 2D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
| Study group | Role | What they receive |
|---|---|---|
| 3D Laparoscopic Surgery | Experimental | 3D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. Receives: Procedure: 3D Laparoscopic Surgery |
| 2D Laparoscopic Surgery | Active comparator | 2D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. Receives: Procedure: 2D Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating time
Operating time
Measured: 1 day
Secondary outcomes (12)
Intraoperative situation
The number of lymph node dissection, the number of positive lymph nodes, intraoperative lymph node dissection time(regional analysis: infrapyloric area lymph node, suprapancreatic area lymph node, splenic hilar area lymph node, cardial area lymph node), intracavitary anastomosis time(patients who undergo totally laparoscopic surgery are analyzed), intraoperative blood loss, intraoperative injury, the amount of use of titanium clip, the rate of conversion to laparotomy
Measured: 1 day
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.
Measured: 10 days
Complication
Early complications occurred within 30 days after operation: pulmonary infection, incision complication, intestinal obstruction, abdominal infection, anastomotic bleeding, anastomotic fistula, gastric emptying; Long-term complications (30 days later after operation): anastomotic stenosis, intestinal obstruction, dumping syndrome
Measured: 30 days;36 months
The postoperative pathology
The postoperative pathological type and pTNM stage.
Measured: 7 days
Inflammatory and immune response
The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
Morbidity and mortality
The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.
Measured: 30 days;36 months
Hospitalization expenses
The cost from admission to discharge
Measured: 1 months
3-year disease free survival rate
Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Measured: 36 months
3-year overall survival rate
Overall survival was defined as the time from surgery to death from any cause
Measured: 36 months
5-year disease free survival rate
Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Measured: 60 months
5-year overall survival rate
Overall survival was defined as the time from surgery to death from any cause
Measured: 60 months
Recurrence patterns
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study start1 Jan 2015
- Primary completion26 Apr 2016
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Changming Huang, M.D.,Ph.D., Study chair, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327481
- Sponsor's protocol ID
- FUGES-001
- Status last verified
- Apr 2023
- First submitted
- 24 Dec 2014
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhao W, Zhong Q, Li BL, Weng CM, Zhang HX, Wang G, Zhang ZQ, Wu YX, Wu D, Chen JY, Chen QY, Zheng CH, Huang CM, Xie JW. Immune-inflammatory-fibrinogen score as a novel prognostic biomarker in patients with gastric cancer undergoing radical gastrectomy: a multicenter study. World J Surg Oncol. 2026 Jun 1;24(1):322. doi: 10.1186/s12957-026-04439-8.
PubMed 42226295Wei LH, Zheng HL, Liu ZY, Du XQ, Chen CS, Xu BB, Zheng HH, Lin GT, Xie JW, Zheng CH, Wang JB, Huang CM, Li P. Preoperative visceral fat area predicts intraoperative adverse events during lymphadenectomy in laparoscopic gastrectomy for gastric cancer: a post hoc analysis. Surg Endosc. 2025 Apr;39(4):2275-2287. doi: 10.1007/s00464-025-11602-x. Epub 2025 Feb 12.
PubMed 39937241Xu BB, Zheng HL, Chen CS, Xu LL, Xue Z, Wei LH, Zheng HH, Shen LL, Zheng CH, Li P, Xie JW, Lin JX, Zheng YH, Huang CM. Development and validation of a preoperative radiomics-based nomogram to identify patients who can benefit from splenic hilar lymphadenectomy: a pooled analysis of three prospective trials. Int J Surg. 2024 Jul 1;110(7):4053-4061. doi: 10.1097/JS9.0000000000001337.
PubMed 38980664Zhong Q, Chen JY, Shang-Guan ZX, Liu ZY, Lin GT, Wu D, Jiang YM, Wang JB, Lin JX, Chen QY, Lin JL, Xie JW, Li P, Lu J, Huang CM, Zheng CH. Long-term oncological outcomes of 3D versus 2D laparoscopic gastrectomy for gastric cancer: a randomized clinical trial. Gastric Cancer. 2024 May;27(3):598-610. doi: 10.1007/s10120-024-01470-0. Epub 2024 Feb 20.
PubMed 38379100Liu ZY, Chen QY, Zhong Q, Li P, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Huang CM, Zheng CH. Intraoperative Adverse Events, Technical Performance, and Surgical Outcomes in Laparoscopic Radical Surgery for Gastric Cancer: A Pooled Analysis From 2 Randomized Trials. Ann Surg. 2023 Aug 1;278(2):222-229. doi: 10.1097/SLA.0000000000005727. Epub 2022 Oct 17.
PubMed 36250322Lu J, Xu Y, Wu Y, Huang XY, Xie JW, Wang JB, Lin JX, Li P, Zheng CH, Huang AM, Huang CM. Tumor-infiltrating CD8+ T cells combined with tumor-associated CD68+ macrophages predict postoperative prognosis and adjuvant chemotherapy benefit in resected gastric cancer. BMC Cancer. 2019 Sep 14;19(1):920. doi: 10.1186/s12885-019-6089-z.
PubMed 31521128Liu ZY, Chen QY, Zhong Q, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Zheng CH, Huang CM, Li P. Is three-dimensional laparoscopic spleen preserving splenic hilar lymphadenectomy for gastric cancer better than that of two-dimensional? Analysis of a prospective clinical research study. Surg Endosc. 2019 Oct;33(10):3425-3435. doi: 10.1007/s00464-018-06640-7. Epub 2019 Feb 26.
PubMed 30809728Xu BB, Lu J, Zheng ZF, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng CH, Huang CM, Li P. The predictive value of the preoperative C-reactive protein-albumin ratio for early recurrence and chemotherapy benefit in patients with gastric cancer after radical gastrectomy: using randomized phase III trial data. Gastric Cancer. 2019 Sep;22(5):1016-1028. doi: 10.1007/s10120-019-00936-w. Epub 2019 Feb 9.
PubMed 30739259Zheng CH, Lu J, Zheng HL, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang CM. Comparison of 3D laparoscopic gastrectomy with a 2D procedure for gastric cancer: A phase 3 randomized controlled trial. Surgery. 2018 Feb;163(2):300-304. doi: 10.1016/j.surg.2017.09.053. Epub 2017 Nov 28.
PubMed 29195739Lu J, Zheng CH, Zheng HL, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang CM. Randomized, controlled trial comparing clinical outcomes of 3D and 2D laparoscopic surgery for gastric cancer: an interim report. Surg Endosc. 2017 Jul;31(7):2939-2945. doi: 10.1007/s00464-016-5310-2. Epub 2016 Nov 8.
PubMed 27826781
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer
- ClinicalTrials.gov ID
- NCT02327481
- Acronym / sponsor ID
- FUGES-001
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 26 Apr 2016 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 30 Dec 2014 (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 purpose of this study is to explore the feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied.
Detailed description
A prospective randomized comparison of 3D and 2D laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 3D laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year/5-year survival and recurrence rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Laparoscopic Surgery | Experimental | Procedure: 3D Laparoscopic Surgery3D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. |
| 2D Laparoscopic Surgery | Active comparator | Procedure: 2D Laparoscopic Surgery2D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (1)Age from over 19 to under 74 years
- (2)cT1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- (3)Heart, lungs, kidneys, and other vital organs function well, with no obvious surgical contraindications
- (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around the main abdominal artery, and tumor not a direct violation of the pancreas, spleen, and other surrounding organs
- (5)American Society of Anesthesiology (ASA) score class I, II, or III
Key exclusion criteria (11 listed)
- (1)Women during pregnancy or breast-feeding
- (2)Severe mental disorder
- (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels
- (5)History of unstable angina or myocardial infarction within the past six months
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 |
|---|---|---|
| 3D Laparoscopic SurgeryAfter exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 3D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience. | Procedure or surgery | 3D Laparoscopic Surgery |
| 2D Laparoscopic SurgeryAfter exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 2D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience. | Procedure or surgery | 2D Laparoscopic Surgery |
Primary outcome
Operating time
Time frame: 1 day
Operating time
12 secondary outcomes
Intraoperative situation
Time frame: 1 day
Postoperative recovery course
Time frame: 10 days
Complication
Time frame: 30 days;36 months
The postoperative pathology
Time frame: 7 days
Inflammatory and immune response
Time frame: 7 days
Morbidity and mortality
Time frame: 30 days;36 months
Hospitalization expenses
Time frame: 1 months
3-year disease free survival rate
Time frame: 36 months
3-year overall survival rate
Time frame: 36 months
5-year disease free survival rate
Time frame: 60 months
5-year overall survival rate
Time frame: 60 months
Recurrence patterns
Time frame: 60 months
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 7 Apr 2023.
- Derived from this study: PubMed 42226295Zhao W, Zhong Q, Li BL, Weng CM, Zhang HX, Wang G, Zhang ZQ, Wu YX, Wu D, Chen JY, Chen QY, Zheng CH, Huang CM, Xie JW. Immune-inflammatory-fibrinogen score as a novel prognostic biomarker in patients with gastric cancer undergoing radical gastrectomy: a multicenter study. World J Surg Oncol. 2026 Jun 1;24(1):322. doi: 10.1186/s12957-026-04439-8.
- Derived from this study: PubMed 39937241Wei LH, Zheng HL, Liu ZY, Du XQ, Chen CS, Xu BB, Zheng HH, Lin GT, Xie JW, Zheng CH, Wang JB, Huang CM, Li P. Preoperative visceral fat area predicts intraoperative adverse events during lymphadenectomy in laparoscopic gastrectomy for gastric cancer: a post hoc analysis. Surg Endosc. 2025 Apr;39(4):2275-2287. doi: 10.1007/s00464-025-11602-x. Epub 2025 Feb 12.
- Derived from this study: PubMed 38980664Xu BB, Zheng HL, Chen CS, Xu LL, Xue Z, Wei LH, Zheng HH, Shen LL, Zheng CH, Li P, Xie JW, Lin JX, Zheng YH, Huang CM. Development and validation of a preoperative radiomics-based nomogram to identify patients who can benefit from splenic hilar lymphadenectomy: a pooled analysis of three prospective trials. Int J Surg. 2024 Jul 1;110(7):4053-4061. doi: 10.1097/JS9.0000000000001337.
- Derived from this study: PubMed 38379100Zhong Q, Chen JY, Shang-Guan ZX, Liu ZY, Lin GT, Wu D, Jiang YM, Wang JB, Lin JX, Chen QY, Lin JL, Xie JW, Li P, Lu J, Huang CM, Zheng CH. Long-term oncological outcomes of 3D versus 2D laparoscopic gastrectomy for gastric cancer: a randomized clinical trial. Gastric Cancer. 2024 May;27(3):598-610. doi: 10.1007/s10120-024-01470-0. Epub 2024 Feb 20.
- Derived from this study: PubMed 36250322Liu ZY, Chen QY, Zhong Q, Li P, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Huang CM, Zheng CH. Intraoperative Adverse Events, Technical Performance, and Surgical Outcomes in Laparoscopic Radical Surgery for Gastric Cancer: A Pooled Analysis From 2 Randomized Trials. Ann Surg. 2023 Aug 1;278(2):222-229. doi: 10.1097/SLA.0000000000005727. Epub 2022 Oct 17.
- Derived from this study: PubMed 31521128Lu J, Xu Y, Wu Y, Huang XY, Xie JW, Wang JB, Lin JX, Li P, Zheng CH, Huang AM, Huang CM. Tumor-infiltrating CD8+ T cells combined with tumor-associated CD68+ macrophages predict postoperative prognosis and adjuvant chemotherapy benefit in resected gastric cancer. BMC Cancer. 2019 Sep 14;19(1):920. doi: 10.1186/s12885-019-6089-z.
- Derived from this study: PubMed 30809728Liu ZY, Chen QY, Zhong Q, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Zheng CH, Huang CM, Li P. Is three-dimensional laparoscopic spleen preserving splenic hilar lymphadenectomy for gastric cancer better than that of two-dimensional? Analysis of a prospective clinical research study. Surg Endosc. 2019 Oct;33(10):3425-3435. doi: 10.1007/s00464-018-06640-7. Epub 2019 Feb 26.
- Derived from this study: PubMed 30739259Xu BB, Lu J, Zheng ZF, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng CH, Huang CM, Li P. The predictive value of the preoperative C-reactive protein-albumin ratio for early recurrence and chemotherapy benefit in patients with gastric cancer after radical gastrectomy: using randomized phase III trial data. Gastric Cancer. 2019 Sep;22(5):1016-1028. doi: 10.1007/s10120-019-00936-w. Epub 2019 Feb 9.
- Derived from this study: PubMed 29195739Zheng CH, Lu J, Zheng HL, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang CM. Comparison of 3D laparoscopic gastrectomy with a 2D procedure for gastric cancer: A phase 3 randomized controlled trial. Surgery. 2018 Feb;163(2):300-304. doi: 10.1016/j.surg.2017.09.053. Epub 2017 Nov 28.
- Derived from this study: PubMed 27826781Lu J, Zheng CH, Zheng HL, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang CM. Randomized, controlled trial comparing clinical outcomes of 3D and 2D laparoscopic surgery for gastric cancer: an interim report. Surg Endosc. 2017 Jul;31(7):2939-2945. doi: 10.1007/s00464-016-5310-2. Epub 2016 Nov 8.
- 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.
Changming Huang, M.D.,Ph.D. study chair
Fujian Medical University Union Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 3D Laparoscopic Surgery and 2D Laparoscopic Surgery in people with Stomach Neoplasms, run by Fujian Medical University.
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 6 inclusion and 11 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 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Operating time (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327481, which also lists 10 linked publications.
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 7 Apr 2023.