Rectal NeoplasmsNCT04265417

Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction

An observational study of Rectal Neoplasms and Robotic Surgery, run by Taiyuan Li.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rectal Neoplasms, Robotic Surgery, Natural Orifice Specimen Extraction Surgery
What is being tested?: Robotic Assisted Rectal Cancer Resection Alone and Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction
Type of treatment: Surgery or procedure
How many people: 98 participants
Where: No sites listed yet
Study dates: 6 Jan 2015to 1 Dec 2016
Phase: Observational
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: From January 2015 to November 2016, a consecutive wave of patients with rectal cancer underwent conventional robotic assisted rectal cancer resection and robotic rectal cancer resection with natural orifice extraction were invited to participate in this study.

Who may be able to join

T stage 1-3;
aged between 18 to 75;
the tumor margin is at least 4 cm from the anus;
body mass index ≤30kg/m2;
no distant metastases； (6）tumor size≤5cm.

Who cannot join

emergency surgery for intestinal obstruction or massive bleeding;
history of abdominal or pelvic surgery.

About this study

Read the detailed description

Robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. However, it's safety and feasibility remain undiscussed and controversial. This study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question. From January 2015 to November 2016, a consecutive wave of 49 patients underwent robotic rectal cancer resection with natural orifice extraction and 49 matched patients underwent conventional robotic assisted rectal cancer resection were systematically analyzed in this study.

Conditions: Rectal Neoplasms, Robotic Surgery, Natural Orifice Specimen Extraction Surgery
Being tested: Robotic Assisted Rectal Cancer Resection Alone, Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Robotic Assisted Rectal Cancer Resection AloneProcedure or surgery
participants in this group underwent robotic assisted rectal cancer resection alone, the specimens were extracted through the incision on the abdominal wall.
Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen ExtractionProcedure or surgery
participants in this group underwent robotic rectal cancer resection，the specimens were extractd through anus and vagina.

Study groups in NCT04265417
Study group	Role	What they receive
RARC group		Participants in this group underwent robotic assisted rectal cancer resection Receives: Procedure: Robotic Assisted Rectal Cancer Resection Alone
NOSE group		Participants in this group underwent robotic rectal cancer resection assisted rectal with natural orifice extraction Receives: Procedure: Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall survival
To determine the survival differences between NOSE group and RARC group. Overall survival is defined as the time from surgery to death from any causes
Measured: Up to 36 months
Disease-free survival
To determine the survival differences between NOSE group and RARC group. Disease-free survival is defined as the time from surgery to local or distant recurrence
Measured: Up to 36 months

Secondary outcomes (14)

Operation time
To determine the differences between NOSE group and RARC group
Measured: 1 day
Estimated intraoperative blood loss
To determine the differences between NOSE group and RARC group
Measured: 1 day
Postoperative hospital stay
To determine the surgical and patients burdern differences between NOSE group and RARC group
Measured: 30 days
Postoperative visual analogue scale scale on day 1
To determine the surgical differences between NOSE group and RARC group. Maxium sacle is 10, miniun scale is 0. 0 represents no pain. 10 represents maximun pain.
Measured: 1 day
Time to pass flatus
To determine the surgical differences between NOSE group and RARC group
Measured: 30 days
Hospitalization costs
to determine the patients burden differences between NOSE group and RARC group
Measured: 30 day
Specimen length
To determine the surgical differences between NOSE group and RARC group
Measured: 30 day
Proximal margin
To determine the pathological differences between NOSE group and RARC group
Measured: 30 day
Distal margin
To determine the pathological differences between NOSE group and RARC group
Measured: 30 days
Histological differentiation
To determine the pathological differences between NOSE group and RARC group
Measured: 30 days
Number of lymph nodes harvested
To determine the pathological differences between NOSE group and RARC group
Measured: 30 days
Postoperative white blood cell count
To determine the surgical stress response differences NOSE group and RARC group
Measured: 30 days
Postoperative procalcitonin
To determine the surgical stress response differences NOSE group and RARC group
Measured: 30 days
Postoperative C-reactive protein
To determine the surgical stress response differences NOSE group and RARC group
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 20151 Dec 2016

First posted11 Feb 2020
Study start6 Jan 2015
Primary completion1 Dec 2016
Study completion1 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rectal NeoplasmsStudies 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04265417
Sponsor's protocol ID: RARN
Status last verified: Feb 2020
First submitted: 8 Feb 2020
Last updated: 18 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

All Rectal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction
ClinicalTrials.gov ID: NCT04265417
Acronym / sponsor ID: RARN
Conditions: Rectal Neoplasms, Robotic Surgery, Natural Orifice Specimen Extraction Surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Taiyuan LiUniversity, hospital or other
Study start: 6 Jan 2015 (actual)
Primary completion: 1 Dec 2016 (actual)
Study completion: 1 Dec 2016 (actual)
First posted: 11 Feb 2020 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
RARC group	–	Procedure: Robotic Assisted Rectal Cancer Resection AloneParticipants in this group underwent robotic assisted rectal cancer resection
NOSE group	–	Procedure: Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen ExtractionParticipants in this group underwent robotic rectal cancer resection assisted rectal with natural orifice extraction

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: From January 2015 to November 2016, a consecutive wave of patients with rectal cancer underwent conventional robotic assisted rectal cancer resection and robotic rectal cancer resection with natural orifice extraction were invited to participate in this study.

Key inclusion criteria (5 listed)

T stage 1-3;
aged between 18 to 75;
the tumor margin is at least 4 cm from the anus;
body mass index ≤30kg/m2;
no distant metastases； (6）tumor size≤5cm.

Key exclusion criteria (2 listed)

emergency surgery for intestinal obstruction or massive bleeding;
history of abdominal or pelvic surgery.

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
Robotic Assisted Rectal Cancer Resection Aloneparticipants in this group underwent robotic assisted rectal cancer resection alone, the specimens were extracted through the incision on the abdominal wall.	Procedure or surgery	RARC group
Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extractionparticipants in this group underwent robotic rectal cancer resection，the specimens were extractd through anus and vagina.	Procedure or surgery	NOSE group

Primary outcome

Overall survival
Time frame: Up to 36 months
To determine the survival differences between NOSE group and RARC group. Overall survival is defined as the time from surgery to death from any causes
Disease-free survival
Time frame: Up to 36 months
To determine the survival differences between NOSE group and RARC group. Disease-free survival is defined as the time from surgery to local or distant recurrence

14 secondary outcomes

Operation time
Time frame: 1 day
Estimated intraoperative blood loss
Time frame: 1 day
Postoperative hospital stay
Time frame: 30 days
Postoperative visual analogue scale scale on day 1
Time frame: 1 day
Time to pass flatus
Time frame: 30 days
Hospitalization costs
Time frame: 30 day
Specimen length
Time frame: 30 day
Proximal margin
Time frame: 30 day
Distal margin
Time frame: 30 days
Histological differentiation
Time frame: 30 days
Number of lymph nodes harvested
Time frame: 30 days
Postoperative white blood cell count
Time frame: 30 days
Postoperative procalcitonin
Time frame: 30 days
Postoperative C-reactive protein
Time frame: 30 days

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 18 Feb 2020.
Individual participant dataSharing planned: No

Related trials for Rectal Neoplasms

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Neoplasms and Robotic Surgery, run by Taiyuan Li.

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 2 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 18 Feb 2020. 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?

Overall survival (time frame: Up to 36 months). The study lists 2 primary outcomes in all. 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 NCT04265417.

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 18 Feb 2020.