Genito Urinary Function EvaluationNCT02153801
Genito Urinary Function With High or Low Inferior Mesenteric Artery Ligation in Laparoscopic Anterior Rectal Resection
A study testing During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision . in people with Genito Urinary Function Evaluation, run by Niguarda Hospital at 1 site in Italy.
Trial summary
The aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left Colic Artery by a prospective randomized trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genito Urinary Function Evaluation
- What is being tested?
- During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- middle or low rectal cancer (from 0 to 12 cm from the anal verge), American Society Anesthesiologist (ASA) I II III, Body Mass index (BMI) lower than 30.
Who cannot join
- prior surgery on the abdominal aorta,
- conversion to laparotomy,
- intraoperative decision for colostomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sexual Urinary Function in Patients Undergoing Laparoscopic Low Anterior Resection With Total Mesorectal Excision With High Or Low Ligation of the Inferior Mesenteric Artery With Preservation of Left Colic Artery Multicentre Randomized Trial
The aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left Colic Artery by a prospective randomized trial.
Read the detailed description
The level of arterial ligation can affect genito-urinary function (injury to the superior hypogastric plexus), extent (and yield) of lymphadenectomy, distal colonic arterial perfusion (distal colonic arterial perfusion could be deficient due to degenerative disease), sympathic nerve injures. Moreover, colonic stump blood supply together with anastomosis tension are the main factors in developing leaks in rectal surgery and is dependent of the level of ligation. The aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left Colic Artery by a prospective randomized trial.
Genito-urinary function will be evaluated with IIEF-5, Internation Consultation Incontinence Modular Questionnarie (ICIQ), Female Sexual Function Index (FSFI), International Index of erectile Function (IIEF) questionnaries and uroflowmetric test pre operatively.
Surgery will be as follow:
The following steps are required in all cases, independently of randomization. The first step consist in the opening of the left part of the gastrocolic ligament and the division of the left part of transverse mesocolon. The splenocolic and phrenocolic attachments are then divided, achieving complete dissection of the left colonic angle. The pelvic peritoneum is opened below the sacral promontory and the hypogastric nerves are identified and preserved. The common iliac veins, the genitofemoral nerve, the gonadic vessels, and the left ureter are successively identified and preserved.
For High Ligation The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.
For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta.
For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter.
Once the descending colonic tract is completely detached from the left parietocolic gutter, dissection of the rectum starts by incision of the peritoneal fold in the pelvis. Total Mesorectal Excision (TME) is then performed according to the principles of Heald.
Colonoscopy will be performed 30 days after surgery to evaluate the anastomosis (leakage, signs of ischemia. Accurate description and pictures of the anastomosis will be produced. IIEF-5, ICIQ, FSFI, International Index of erectile Function (IIEF) and uroflowmetric test will be performed 1 and 9 months post-operatively
- Conditions
- Genito Urinary Function Evaluation
- Being tested
- During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .
- Keywords
- High Ligation, Low ligation, Genito-urinary function, laparoscopy, rectal cancer, aterior resection, Total mesorectal Excision, anastomotic leak.
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .Procedure or surgery
For High Ligation The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.
For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta.
For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter.
| Study group | Role | What they receive |
|---|---|---|
| Low Inferior Mesenterci Artery Ligation | Active comparator | The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin. Receives: Procedure: During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision . |
| High Inferior Mesenterci Artery Ligation | Other | For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta.
For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter. Receives: Procedure: During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual and Urinary Function assessed with with International Prostatic Symptoms Score (IPSS), ICIQ, IIEF, FSFI questionnaires
Measured: 9 months from laparoscopic RAR + TME
Secondary outcomes (5)
Incidence of anastomotic leak
Measured: 1 month from laparoscopic RAR + TME
Sexual and Urinary Function assessed with with IPSS ICIQ IIEF FSFI questionnaires
Measured: 1 month from laparoscopic RAR + TME
Urinary Function assessed with Uroflowmetric examination
Measured: 1 months from laparoscopic RAR + TME
Sexual and Urinary Function assessed with with IPSS ICIQ IIEF FSFI questionnaires
Measured: 9 month from laparoscopic RAR + TME
Urinary Function assessed with Uroflowmetric examination
Measured: 9 months from laparoscopic RAR + TME
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Genito Urinary Function EvaluationStudies 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
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulio Mari, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153801
- Sponsor's protocol ID
- EudraCT Number 986
- Status last verified
- Mar 2017
- First submitted
- 19 May 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mari GM, Crippa J, Achilli P, Montroni I, Ugolini G, Taffurelli G, Cocozza E, Borroni G, Valenti F, Roscio F, Ferrari G, Origi M, Zuliani W, Pugliese R, Costanzi ATM, Fingherut A, Maggioni D. High Versus Low Ligation of the Inferior Mesenteric Artery During Rectal Resection for Cancer: Oncological Outcomes After Three Years of Follow-Up From the HIGHLOW Trial. Ann Surg Open. 2020 Oct 19;1(2):e017. doi: 10.1097/AS9.0000000000000017. eCollection 2020 Dec.
PubMed 37637440Mari G, Santambrogio G, Crippa J, Cirocchi R, Origi M, Achilli P, Ferrari G, Megna S, Desio M, Cocozza E, Maggioni D, Montroni I, Spinelli A, Zuliani W, Costanzi A, Crestale S, Petri R, Bicelli N, Pedrazzani C, Boccolini A, Taffurelli G, Fingerhut A; AIMS Academy Clinical Research Network. 5 year oncological outcomes of the HIGHLOW randomized clinical trial. Eur J Surg Oncol. 2023 Mar;49(3):641-646. doi: 10.1016/j.ejso.2022.10.017. Epub 2022 Oct 28.
PubMed 36335077Mari GM, Crippa J, Cocozza E, Berselli M, Livraghi L, Carzaniga P, Valenti F, Roscio F, Ferrari G, Mazzola M, Magistro C, Origi M, Forgione A, Zuliani W, Scandroglio I, Pugliese R, Costanzi ATM, Maggioni D. Low Ligation of Inferior Mesenteric Artery in Laparoscopic Anterior Resection for Rectal Cancer Reduces Genitourinary Dysfunction: Results From a Randomized Controlled Trial (HIGHLOW Trial). Ann Surg. 2019 Jun;269(6):1018-1024. doi: 10.1097/SLA.0000000000002947.
PubMed 31082897Mari G, Maggioni D, Costanzi A, Miranda A, Rigamonti L, Crippa J, Magistro C, Di Lernia S, Forgione A, Carnevali P, Nichelatti M, Carzaniga P, Valenti F, Rovagnati M, Berselli M, Cocozza E, Livraghi L, Origi M, Scandroglio I, Roscio F, De Luca A, Ferrari G, Pugliese R. "High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial). Trials. 2015 Jan 27;16:21. doi: 10.1186/s13063-014-0537-5.
PubMed 25623323
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Urinary Function in Patients Undergoing Laparoscopic Low Anterior Resection With Total Mesorectal Excision With High Or Low Ligation of the Inferior Mesenteric Artery With Preservation of Left Colic Artery Multicentre Randomized Trial
- ClinicalTrials.gov ID
- NCT02153801
- Acronym / sponsor ID
- EudraCT Number 986
- Conditions
- Genito Urinary Function Evaluation
- Keywords
- High Ligation, Low ligation, Genito-urinary function, laparoscopy, rectal cancer, aterior resection, Total mesorectal Excision, anastomotic leak.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 3 Jun 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 aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left Colic Artery by a prospective randomized trial.
Detailed description
The level of arterial ligation can affect genito-urinary function (injury to the superior hypogastric plexus), extent (and yield) of lymphadenectomy, distal colonic arterial perfusion (distal colonic arterial perfusion could be deficient due to degenerative disease), sympathic nerve injures. Moreover, colonic stump blood supply together with anastomosis tension are the main factors in developing leaks in rectal surgery and is dependent of the level of ligation. The aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left Colic Artery by a prospective randomized trial.
Genito-urinary function will be evaluated with IIEF-5, Internation Consultation Incontinence Modular Questionnarie (ICIQ), Female Sexual Function Index (FSFI), International Index of erectile Function (IIEF) questionnaries and uroflowmetric test pre operatively.
Surgery will be as follow:
The following steps are required in all cases, independently of randomization. The first step consist in the opening of the left part of the gastrocolic ligament and the division of the left part of transverse mesocolon. The splenocolic and phrenocolic attachments are then divided, achieving complete dissection of the left colonic angle. The pelvic peritoneum is opened below the sacral promontory and the hypogastric nerves are identified and preserved. The common iliac veins, the genitofemoral nerve, the gonadic vessels, and the left ureter are successively identified and preserved.
For High Ligation The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.
For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta.
For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter.
Once the descending colonic tract is completely detached from the left parietocolic gutter, dissection of the rectum starts by incision of the peritoneal fold in the pelvis. Total Mesorectal Excision (TME) is then performed according to the principles of Heald.
Colonoscopy will be performed 30 days after surgery to evaluate the anastomosis (leakage, signs of ischemia. Accurate description and pictures of the anastomosis will be produced. IIEF-5, ICIQ, FSFI, International Index of erectile Function (IIEF) and uroflowmetric test will be performed 1 and 9 months post-operatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Inferior Mesenterci Artery Ligation | Active comparator | Procedure: During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin. |
| High Inferior Mesenterci Artery Ligation | Other | Procedure: During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta. For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- middle or low rectal cancer (from 0 to 12 cm from the anal verge), American Society Anesthesiologist (ASA) I II III, Body Mass index (BMI) lower than 30.
Key exclusion criteria (3 listed)
- prior surgery on the abdominal aorta,
- conversion to laparotomy,
- intraoperative decision for colostomy.
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 |
|---|---|---|
| During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .For High Ligation The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin. For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta. For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter. | Procedure or surgery | High Inferior Mesenterci Artery Ligation, Low Inferior Mesenterci Artery Ligation |
Primary outcome
Sexual and Urinary Function assessed with with International Prostatic Symptoms Score (IPSS), ICIQ, IIEF, FSFI questionnaires
Time frame: 9 months from laparoscopic RAR + TME
5 secondary outcomes
Incidence of anastomotic leak
Time frame: 1 month from laparoscopic RAR + TME
Sexual and Urinary Function assessed with with IPSS ICIQ IIEF FSFI questionnaires
Time frame: 1 month from laparoscopic RAR + TME
Urinary Function assessed with Uroflowmetric examination
Time frame: 1 months from laparoscopic RAR + TME
Sexual and Urinary Function assessed with with IPSS ICIQ IIEF FSFI questionnaires
Time frame: 9 month from laparoscopic RAR + TME
Urinary Function assessed with Uroflowmetric examination
Time frame: 9 months from laparoscopic RAR + TME
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 4 Apr 2017.
- Derived from this study: PubMed 37637440Mari GM, Crippa J, Achilli P, Montroni I, Ugolini G, Taffurelli G, Cocozza E, Borroni G, Valenti F, Roscio F, Ferrari G, Origi M, Zuliani W, Pugliese R, Costanzi ATM, Fingherut A, Maggioni D. High Versus Low Ligation of the Inferior Mesenteric Artery During Rectal Resection for Cancer: Oncological Outcomes After Three Years of Follow-Up From the HIGHLOW Trial. Ann Surg Open. 2020 Oct 19;1(2):e017. doi: 10.1097/AS9.0000000000000017. eCollection 2020 Dec.
- Derived from this study: PubMed 36335077Mari G, Santambrogio G, Crippa J, Cirocchi R, Origi M, Achilli P, Ferrari G, Megna S, Desio M, Cocozza E, Maggioni D, Montroni I, Spinelli A, Zuliani W, Costanzi A, Crestale S, Petri R, Bicelli N, Pedrazzani C, Boccolini A, Taffurelli G, Fingerhut A; AIMS Academy Clinical Research Network. 5 year oncological outcomes of the HIGHLOW randomized clinical trial. Eur J Surg Oncol. 2023 Mar;49(3):641-646. doi: 10.1016/j.ejso.2022.10.017. Epub 2022 Oct 28.
- Derived from this study: PubMed 31082897Mari GM, Crippa J, Cocozza E, Berselli M, Livraghi L, Carzaniga P, Valenti F, Roscio F, Ferrari G, Mazzola M, Magistro C, Origi M, Forgione A, Zuliani W, Scandroglio I, Pugliese R, Costanzi ATM, Maggioni D. Low Ligation of Inferior Mesenteric Artery in Laparoscopic Anterior Resection for Rectal Cancer Reduces Genitourinary Dysfunction: Results From a Randomized Controlled Trial (HIGHLOW Trial). Ann Surg. 2019 Jun;269(6):1018-1024. doi: 10.1097/SLA.0000000000002947.
- Derived from this study: PubMed 25623323Mari G, Maggioni D, Costanzi A, Miranda A, Rigamonti L, Crippa J, Magistro C, Di Lernia S, Forgione A, Carnevali P, Nichelatti M, Carzaniga P, Valenti F, Rovagnati M, Berselli M, Cocozza E, Livraghi L, Origi M, Scandroglio I, Roscio F, De Luca A, Ferrari G, Pugliese R. "High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial). Trials. 2015 Jan 27;16:21. doi: 10.1186/s13063-014-0537-5.
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.
Giulio Mari, MD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision . in people with Genito Urinary Function Evaluation, run by Niguarda Hospital at 1 site in Italy.
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: finished, as of the sponsor's last update on 4 Apr 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 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?
Sexual and Urinary Function assessed with with International Prostatic Symptoms Score (IPSS), ICIQ, IIEF, FSFI questionnaires (time frame: 9 months from laparoscopic RAR + TME). 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 NCT02153801, which also lists 4 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 4 Apr 2017.