Rectal CancerNCT03911167
An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer
An observational study of Rectal Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
A retrospective study was done on the medical records for 24 rectal cancer patients underwent robotic proctectomy from September 2017 to July 2018 at the First Affiliated Hospital of Xi'an Jiaotong University.In the same department,a total of 25 patients who treated with laparoscopic proctectomy and 24 patients… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- open, laparoscopic, and robotic
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Jul 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosis of rectal cancer
Who may be able to join
- endoscopic biopsy pathological diagnosis of rectal cancer is clear, preoperative CT, MRI examination did not see the tumor directly invaded the surrounding organs;
- blood test, cardiac ultrasound, lung ventilation function and other preoperative examination without absolute surgical contraindications;
- without distant metastasis such as liver, lung, bone, and abdominal cavity.
Who cannot join
- there is distant organ transfer or extensive abdominal metastasis;
- emergency surgery for acute intestinal obstruction, hemorrhage, perforation, intestinal rupture, etc.;
- combined with other primary malignant tumors;
- other colonectomy and combined with other organ resection;
- patients with severe basic diseases unable to tolerate surgery;
- pregnant and lactating women;
- patients who underwent neoadjuvant radiotherapy and chemotherapy before surgery;
- those who underwent palliative surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
A retrospective study was done on the medical records for 24 rectal cancer patients underwent robotic proctectomy from September 2017 to July 2018 at the First Affiliated Hospital of Xi'an Jiaotong University.In the same department,a total of 25 patients who treated with laparoscopic proctectomy and 24 patients underwent open proctectomy were were selected as controls in a 1:1:1 ratio. Comparing the perioperative conditions and hospitalization related costs of the three groups.
- Conditions
- Rectal Cancer
- Being tested
- open, laparoscopic, and robotic
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open, laparoscopic, and roboticProcedure or surgery
Radical resection of rectal cancer in robotic, laparoscopic, and open approach
| Study group | Role | What they receive |
|---|---|---|
| RG | RG: robotic group Receives: Procedure: open, laparoscopic, and robotic | |
| LG | LG:laparoscopic group, Receives: Procedure: open, laparoscopic, and robotic | |
| OG | OG：open group Receives: Procedure: open, laparoscopic, and robotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication rate，%
Measured: 2 weeks
Secondary outcomes (8)
Urine tube time,days;
Measured: 2 weeks
operation time,minutes;
Measured: 2 weeks
intraoperative bleeding,ml;
Measured: 2 weeks
number of lymph node detection,
Measured: 2 weeks
exhaust time,days;
Measured: 2 weeks
intake time, days;
Measured: 2 weeks
postoperative hospital stay,days;
Measured: 2 weeks
hospitalization expenses,yuan
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Sep 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911167
- Sponsor's protocol ID
- XJTU1AF2019LSK-009
- Status last verified
- Jan 2019
- First submitted
- 26 Mar 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer
- ClinicalTrials.gov ID
- NCT03911167
- Acronym / sponsor ID
- XJTU1AF2019LSK-009
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 10 Apr 2019 (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.
A retrospective study was done on the medical records for 24 rectal cancer patients underwent robotic proctectomy from September 2017 to July 2018 at the First Affiliated Hospital of Xi'an Jiaotong University.In the same department,a total of 25 patients who treated with laparoscopic proctectomy and 24 patients underwent open proctectomy were were selected as controls in a 1:1:1 ratio. Comparing the perioperative conditions and hospitalization related costs of the three groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RG | – | Procedure: open, laparoscopic, and roboticRG: robotic group |
| LG | – | Procedure: open, laparoscopic, and roboticLG:laparoscopic group, |
| OG | – | Procedure: open, laparoscopic, and roboticOG：open group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of rectal cancer
Key inclusion criteria (3 listed)
- endoscopic biopsy pathological diagnosis of rectal cancer is clear, preoperative CT, MRI examination did not see the tumor directly invaded the surrounding organs;
- blood test, cardiac ultrasound, lung ventilation function and other preoperative examination without absolute surgical contraindications;
- without distant metastasis such as liver, lung, bone, and abdominal cavity.
Key exclusion criteria (8 listed)
- there is distant organ transfer or extensive abdominal metastasis;
- emergency surgery for acute intestinal obstruction, hemorrhage, perforation, intestinal rupture, etc.;
- combined with other primary malignant tumors;
- other colonectomy and combined with other organ resection;
- patients with severe basic diseases unable to tolerate 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 |
|---|---|---|
| open, laparoscopic, and roboticRadical resection of rectal cancer in robotic, laparoscopic, and open approach | Procedure or surgery | LG, OG, RG |
Primary outcome
Postoperative complication rate，%
Time frame: 2 weeks
8 secondary outcomes
Urine tube time,days;
Time frame: 2 weeks
operation time,minutes;
Time frame: 2 weeks
intraoperative bleeding,ml;
Time frame: 2 weeks
number of lymph node detection,
Time frame: 2 weeks
exhaust time,days;
Time frame: 2 weeks
intake time, days;
Time frame: 2 weeks
postoperative hospital stay,days;
Time frame: 2 weeks
hospitalization expenses,yuan
Time frame: 2 weeks
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 10 Apr 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Postoperative complication rate，% (time frame: 2 weeks). 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 10 Apr 2019.