Colorectal CancerNCT05970133
Robotic Versus Laparoscopy NOSE for Stage I-III Left-sided Colon Cancer
A study testing Colectomy with NOSE procedure in people with Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In this project, the investigator aims to provide the level 1 evidence for the comparison of robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the investigator hypothesize that, with the increased maneuverability of the current robotic system, robotic surgery will be a good option for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colectomy with NOSE procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Apr 2023to 6 Oct 2025
- 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
- Primary colon cancers located at the left sided colonic anatomic location, including distal transverse colon, colonic splenic flexure, descending colon, sigm oid descending colonic junction, sigmoid colon and upper rectum that required the mobilization of colonic splenic flexure to facilitate a curative resection and trans anal specimen extraction ;
- TNM Stage I III adenocarcinomas;
- Curative and elective surgery;
- American Society of Anesthesiology (ASA) class I to III patients;
- Age >18 years.
Who cannot join
- Cecal, ascending, the proximal and middle transverse colon cancers; and the middle or lower rectal cancers;
- Emergency or palliative surgery;
- Evidence of disseminated disease or adjacent organ invasion;
- Primary tumor mass >8 cm in diameter;
- Morbidly obese patients, that is, body mass index (BMI) ≥40 kg/m 2 ;
- Previous major surgery of upper abdomen or pelvis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jin-Tung LIANG, MD, 886-9-72651432, jintung@ntu.edu.tw
About this study
Official title: Functional Recovery and Oncologic Efficacy of Robotic Versus Laparoscopy NOSE for Patients With Stage I III Left Sided Colon Cancer: A Randomized Controlled Trial
In this project, the investigator aims to provide the level 1 evidence for the comparison of robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the investigator hypothesize that, with the increased maneuverability of the current robotic system, robotic surgery will be a good option for patients with stage I-III colorectal cancer requiring a NOSE procedure.
Read the detailed description
Over the past three decades, laparoscopic surgery has evolved incessantly, especially in the field of colorectal surgery. It has been widely accepted by surgeons and patients in light of the better peri-operative outcomes and analogical long-term effectiveness, compared with open surgery for colorectal cancers. However, current conventional laparoscopic colorectal surgery requires an additional abdominal incision for specimen retrieval and sometimes for intestinal reconstruction, which increases the risk of various postoperative complications, including pain, surgical site infection, incisional hernia, and injury to the epigastric artery and abdominal cutaneous nerves, and, consequently, can delay postoperative chemotherapy.
To mitigate these unfavorable outcomes, natural orifice specimen extraction (NOSE) via the anus, stomach, or vagina, was introduced. One randomized trial reported better short-term surgical outcomes, including reduced pain and lower analgesia requirements for laparoscopic NOSE colectomy, compared with conventional laparoscopic colectomy. Transanal specimen extraction has been utilized after laparoscopic colon or rectal cancer surgery and has been found to be feasible, safe, and oncologically sound in selected cases. Several multiport laparoscopic platforms are currently available to complete all NOSE procedures and reestablish intestinal continuity with a single stapled anastomosis, which has been shown to improve short-term results compared with conventional laparoscopic colectomy. However, concerns remain regarding the long-term oncologic safety (tumor cell spillage with local recurrence and long-term survival) when NOSE is used for colorectal malignancy.
A barrier to wider adoption of NOSE is technical difficulty. The mini-laparotomy, in some cases, is used to perform a majority of the operation, as in hand-assisted laparoscopy. Adoption of NOSE by surgeons who typically perform colectomies in this fashion would be faced with a steeper learning curve than surgeons who use the mini-laparotomy solely as a specimen extraction site. On that note, intracorporeal anastomosis is a prerequisite skill for those adopting NOSE. Removal of more proximal specimens, as in a right colectomy, requires the presence of a skilled endoscopist who can snare and pull the specimen endoluminally through the length of the distal gastrointestinal tract. Specimen extraction via the vagina requires a posterior colpotomy, an operative maneuver that is not typically performed by general or colorectal surgeons. Furthermore, these technical challenges are amplified by a lack of standardization of the technique.
The demands for these technical skills are more important in removing right-sided colon pathology, as compared to left-sided pathology. There are inherent anatomic factors that make NOSE for right-sided colon pathology more difficult. Right colectomy specimens extracted through the lower gastrointestinal tract via distal colotomy must travel the length of the remaining transverse, descending, and sigmoid colon, through the rectum and out of the anus using an endoscope. While this was demonstrated to be feasible in 2010 by Eshuis et al, it is inherently difficult due to the anatomically narrow and torturous sigmoid colon. In that series, extraction via colotomy failed in 2 of 10 patients due to the bulk of the specimen. This technique is still performed in some centers, though limitations related to the size of the specimen are stricter than for left-sided colon lesions. This approach has little practicality due to its significant technical challenges, hence its limited use.
Bacterial contamination is always a concern during the NOSE procedure. Most researchers strongly suggest that mechanical bowel preparation, intraoperative transanal lavage with povidone iodine solution, transluminal wound protector, and prophylactic antibiotics are applied to reduce the bacterial load. Recently, a study showed that the risk of bacterial contamination with NOSE was not significantly higher than that in conventional laparoscopic surgery. In some studies, patients who had NOSE did not experience significant postoperative morbidity or laboratory data changes, such as leukocytosis, CRP level elevation, rectal wound-related complications or leakage, than the conventional group.
Tumor size is considered before applying the NOSE procedure. Many authors limit indications to tumors smaller than 3 - 6.5 cm. Some authors have stated that obese patients are not suitable for transrectal specimen extraction and set the BMI cutoff at > 28-35 kg/m2. Most researchers considered patients with a bulky mesocolon, a narrow pelvis, and previous pelvic surgery with severe adhesions were not eligible for NOSE.
It is generally accepted that laparoscopic NOSE can achieve oncological and surgical safety comparable to that of conventional laparoscopic surgery for patients with sigmoid and rectal cancer. Remarkably, Laparoscopic NOSE patients were associated with a shorter hospital stay, shorter time to first flatus or defecation, less postoperative pain, and fewer surgical site infections and total perioperative complications. In general, the operative time in laparoscopic NOSE was longer than that in conventional laparoscopic surgery. The long-term oncological efficacy of laparoscopic NOSE seems to be equivalent to that of conventional laparoscopic surgery. Furthermore, specimen retrieval through alternative routes to avoid an abdominal incision is beneficial for the prevention of incisional hernia.
Currently, robotic surgical approaches are becoming more popular for treating colorectal cancer. Robotic techniques can overcome some technical limitations of laparoscopic surgery, including an unstable camera view and straight laparoscopic instruments. Robotic surgery is advantageous because it provides surgeon-control of the camera, high-definition three-dimensional vision, excellent ergonomics, decreased physiological tremor, more freedom of angles of instruments, and the ability to simultaneously control the camera and two additional instruments that facilitate traction and countertraction, all of which enable to facilitate the procedures, even in difficult settings.
The unique advantages of the surgical robot make colorectal surgery operations more precise and intelligent, providing more options for minimizing operative stress during colorectal surgery. The proximity between the sigmoid colon and rectum to the anal location provides a favorable predisposition for transanal specimen retrieval without significantly increasing the difficulty of the surgical operation. However, to date, only very few studies compared robotic NOSE versus laparoscopic NOSE for the surgery of colorectal cancer. Actually, our preliminary data has shown the safety and feasibility of robotic NOSE, as compared with laparoscopic NOSE for the surgery of colorectal cancer.
Even to date, laparoscopic NOSE procedure for colorectal cancer is still not popular due to the technique difficulty associated with an intra-corporeal anastomosis for NOSE and the oncologic concern of tumor spillage at the staple line during tumor retrieval process. In this respect, the introduction of robotic system can overcome the technical difficulties.
In this project, the investigator aims to provide the level 1 evidence for the comparison of robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the investigator hypothesize that, with the increased maneuverability of the current robotic system, robotic surgery will be a good option for patients with stage I-III colorectal cancer requiring a NOSE procedure.
- Conditions
- Colorectal Cancer
- Being tested
- Colectomy with NOSE procedure
- Keywords
- Colorectal cancer, Natural orifice specimen extraction, Laparoscopic surgery, Robotic surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colectomy with NOSE procedureProcedure or surgery
The specimen will be extract from the anus.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery | Experimental | The patients in this group will undergo laparoscopic surgery. Receives: Procedure: Colectomy with NOSE procedure |
| Robotic surgery | Active comparator | The patients in this group will undergo robotic surgery. Receives: Procedure: Colectomy with NOSE procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The surgical efficiency of both NOSE procedures
The operation time defined as the incision of wound and application of the surgical dressing
Measured: Intraoperative hours with an average of 5 hours
Secondary outcomes (13)
Overall disease-free survival
The duration between surgery and death
Measured: 5 years
Overall recurrence-free survival
The duration between surgery and recurrence
Measured: 5 years
Incontinence
Evaluated by questionnaire
Measured: 6 months
Time to return work
Disability
Measured: 1 year
Total fee and equipment fee
Total Cost
Measured: 3 months
Blood loss
measured by the amount Mof blood in suction bottle and the number of blood soaked gauzes
Measured: Intraoperative hours with an average of 5 years
Conversion rate
Conversion from robotic surgery to laparoscopic surgery or open surgery
Measured: Intraoperative hours with an average of 5 years
Complications
Any complication during or after surgery grading by Calvien -Dindo classification
Measured: 30 days
Wound size
Total length of the wounds
Measured: Intraoperative hours with an average of 5 years
Serum C reactive protein (CRP)
CRP could be an indicator of the severity of surgical stress.
Measured: Throughout the admission with an average of 7 days
Erythrocyte sedimentation rate (ESR)
ESR could be an indicator of the severity of surgical stress.
Measured: Throughout the admission with an average of 7 days
Blood lymphocyte counts
Blood lymphocyte counts could be an indicator of the severity of surgical stress.
Measured: Throughout the admission with an average of 7 days
CD4+ to CD8+ ratio
CD4 to CD8 ratio could be an indicator of the severity of surgical stress.
Measured: ESR could be an indicator of the severity of surgical stress.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start7 Apr 2023
- Primary completion6 Apr 2025 (estimated)
- Study completion6 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Tung LIANG, MD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970133
- Sponsor's protocol ID
- 202301224RINB
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery and Oncologic Efficacy of Robotic Versus Laparoscopy NOSE for Patients With Stage I III Left Sided Colon Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05970133
- Acronym / sponsor ID
- 202301224RINB
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Natural orifice specimen extraction, Laparoscopic surgery, Robotic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 6 Apr 2025 (estimated)
- Study completion
- 6 Oct 2025 (estimated)
- First posted
- 1 Aug 2023 (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.
In this project, the investigator aims to provide the level 1 evidence for the comparison of robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the investigator hypothesize that, with the increased maneuverability of the current robotic system, robotic surgery will be a good option for patients with stage I-III colorectal cancer requiring a NOSE procedure.
Detailed description
Over the past three decades, laparoscopic surgery has evolved incessantly, especially in the field of colorectal surgery. It has been widely accepted by surgeons and patients in light of the better peri-operative outcomes and analogical long-term effectiveness, compared with open surgery for colorectal cancers. However, current conventional laparoscopic colorectal surgery requires an additional abdominal incision for specimen retrieval and sometimes for intestinal reconstruction, which increases the risk of various postoperative complications, including pain, surgical site infection, incisional hernia, and injury to the epigastric artery and abdominal cutaneous nerves, and, consequently, can delay postoperative chemotherapy.
To mitigate these unfavorable outcomes, natural orifice specimen extraction (NOSE) via the anus, stomach, or vagina, was introduced. One randomized trial reported better short-term surgical outcomes, including reduced pain and lower analgesia requirements for laparoscopic NOSE colectomy, compared with conventional laparoscopic colectomy. Transanal specimen extraction has been utilized after laparoscopic colon or rectal cancer surgery and has been found to be feasible, safe, and oncologically sound in selected cases. Several multiport laparoscopic platforms are currently available to complete all NOSE procedures and reestablish intestinal continuity with a single stapled anastomosis, which has been shown to improve short-term results compared with conventional laparoscopic colectomy. However, concerns remain regarding the long-term oncologic safety (tumor cell spillage with local recurrence and long-term survival) when NOSE is used for colorectal malignancy.
A barrier to wider adoption of NOSE is technical difficulty. The mini-laparotomy, in some cases, is used to perform a majority of the operation, as in hand-assisted laparoscopy. Adoption of NOSE by surgeons who typically perform colectomies in this fashion would be faced with a steeper learning curve than surgeons who use the mini-laparotomy solely as a specimen extraction site. On that note, intracorporeal anastomosis is a prerequisite skill for those adopting NOSE. Removal of more proximal specimens, as in a right colectomy, requires the presence of a skilled endoscopist who can snare and pull the specimen endoluminally through the length of the distal gastrointestinal tract. Specimen extraction via the vagina requires a posterior colpotomy, an operative maneuver that is not typically performed by general or colorectal surgeons. Furthermore, these technical challenges are amplified by a lack of standardization of the technique.
The demands for these technical skills are more important in removing right-sided colon pathology, as compared to left-sided pathology. There are inherent anatomic factors that make NOSE for right-sided colon pathology more difficult. Right colectomy specimens extracted through the lower gastrointestinal tract via distal colotomy must travel the length of the remaining transverse, descending, and sigmoid colon, through the rectum and out of the anus using an endoscope. While this was demonstrated to be feasible in 2010 by Eshuis et al, it is inherently difficult due to the anatomically narrow and torturous sigmoid colon. In that series, extraction via colotomy failed in 2 of 10 patients due to the bulk of the specimen. This technique is still performed in some centers, though limitations related to the size of the specimen are stricter than for left-sided colon lesions. This approach has little practicality due to its significant technical challenges, hence its limited use.
Bacterial contamination is always a concern during the NOSE procedure. Most researchers strongly suggest that mechanical bowel preparation, intraoperative transanal lavage with povidone iodine solution, transluminal wound protector, and prophylactic antibiotics are applied to reduce the bacterial load. Recently, a study showed that the risk of bacterial contamination with NOSE was not significantly higher than that in conventional laparoscopic surgery. In some studies, patients who had NOSE did not experience significant postoperative morbidity or laboratory data changes, such as leukocytosis, CRP level elevation, rectal wound-related complications or leakage, than the conventional group.
Tumor size is considered before applying the NOSE procedure. Many authors limit indications to tumors smaller than 3 - 6.5 cm. Some authors have stated that obese patients are not suitable for transrectal specimen extraction and set the BMI cutoff at > 28-35 kg/m2. Most researchers considered patients with a bulky mesocolon, a narrow pelvis, and previous pelvic surgery with severe adhesions were not eligible for NOSE.
It is generally accepted that laparoscopic NOSE can achieve oncological and surgical safety comparable to that of conventional laparoscopic surgery for patients with sigmoid and rectal cancer. Remarkably, Laparoscopic NOSE patients were associated with a shorter hospital stay, shorter time to first flatus or defecation, less postoperative pain, and fewer surgical site infections and total perioperative complications. In general, the operative time in laparoscopic NOSE was longer than that in conventional laparoscopic surgery. The long-term oncological efficacy of laparoscopic NOSE seems to be equivalent to that of conventional laparoscopic surgery. Furthermore, specimen retrieval through alternative routes to avoid an abdominal incision is beneficial for the prevention of incisional hernia.
Currently, robotic surgical approaches are becoming more popular for treating colorectal cancer. Robotic techniques can overcome some technical limitations of laparoscopic surgery, including an unstable camera view and straight laparoscopic instruments. Robotic surgery is advantageous because it provides surgeon-control of the camera, high-definition three-dimensional vision, excellent ergonomics, decreased physiological tremor, more freedom of angles of instruments, and the ability to simultaneously control the camera and two additional instruments that facilitate traction and countertraction, all of which enable to facilitate the procedures, even in difficult settings.
The unique advantages of the surgical robot make colorectal surgery operations more precise and intelligent, providing more options for minimizing operative stress during colorectal surgery. The proximity between the sigmoid colon and rectum to the anal location provides a favorable predisposition for transanal specimen retrieval without significantly increasing the difficulty of the surgical operation. However, to date, only very few studies compared robotic NOSE versus laparoscopic NOSE for the surgery of colorectal cancer. Actually, our preliminary data has shown the safety and feasibility of robotic NOSE, as compared with laparoscopic NOSE for the surgery of colorectal cancer.
Even to date, laparoscopic NOSE procedure for colorectal cancer is still not popular due to the technique difficulty associated with an intra-corporeal anastomosis for NOSE and the oncologic concern of tumor spillage at the staple line during tumor retrieval process. In this respect, the introduction of robotic system can overcome the technical difficulties.
In this project, the investigator aims to provide the level 1 evidence for the comparison of robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the investigator hypothesize that, with the increased maneuverability of the current robotic system, robotic surgery will be a good option for patients with stage I-III colorectal cancer requiring a NOSE procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery | Experimental | Procedure: Colectomy with NOSE procedureThe patients in this group will undergo laparoscopic surgery. |
| Robotic surgery | Active comparator | Procedure: Colectomy with NOSE procedureThe patients in this group will undergo robotic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary colon cancers located at the left sided colonic anatomic location, including distal transverse colon, colonic splenic flexure, descending colon, sigm oid descending colonic junction, sigmoid colon and upper rectum that required the mobilization of colonic splenic flexure to facilitate a curative resection and trans anal specimen extraction ;
- TNM Stage I III adenocarcinomas;
- Curative and elective surgery;
- American Society of Anesthesiology (ASA) class I to III patients;
- Age >18 years.
Key exclusion criteria (6 listed)
- Cecal, ascending, the proximal and middle transverse colon cancers; and the middle or lower rectal cancers;
- Emergency or palliative surgery;
- Evidence of disseminated disease or adjacent organ invasion;
- Primary tumor mass >8 cm in diameter;
- Morbidly obese patients, that is, body mass index (BMI) ≥40 kg/m 2 ;
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 |
|---|---|---|
| Colectomy with NOSE procedureThe specimen will be extract from the anus. | Procedure or surgery | Laparoscopic surgery, Robotic surgery |
Primary outcome
The surgical efficiency of both NOSE procedures
Time frame: Intraoperative hours with an average of 5 hours
The operation time defined as the incision of wound and application of the surgical dressing
13 secondary outcomes
Overall disease-free survival
Time frame: 5 years
Overall recurrence-free survival
Time frame: 5 years
Incontinence
Time frame: 6 months
Time to return work
Time frame: 1 year
Total fee and equipment fee
Time frame: 3 months
Blood loss
Time frame: Intraoperative hours with an average of 5 years
Conversion rate
Time frame: Intraoperative hours with an average of 5 years
Complications
Time frame: 30 days
Wound size
Time frame: Intraoperative hours with an average of 5 years
Serum C reactive protein (CRP)
Time frame: Throughout the admission with an average of 7 days
Erythrocyte sedimentation rate (ESR)
Time frame: Throughout the admission with an average of 7 days
Blood lymphocyte counts
Time frame: Throughout the admission with an average of 7 days
CD4+ to CD8+ ratio
Time frame: ESR could be an indicator of the severity of surgical stress.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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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.
Jin-Tung LIANG, MD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colectomy with NOSE procedure in people with Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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: status not confirmed, as of the sponsor's last update on 20 Sep 2024. 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 Taiwan. 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 Jin-Tung LIANG, MD (886-9-72651432, jintung@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The surgical efficiency of both NOSE procedures (time frame: Intraoperative hours with an average of 5 hours). 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 20 Sep 2024.