Laparoscopic SurgeryNCT03318185
Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma
A study testing gasless single-port laparoscopic surgery and conventional laparoscopic surgery in people with Laparoscopic Surgery, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This project aims to investigate the safety and effectiveness of gasless single-port laparoscopic-assisted radical resection (GSLR) in the treatment of rectal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- gasless single-port laparoscopic surgery and conventional laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 1 Sep 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rectal carcinoma;The distance between tumor and anal verge is 5-15cm; The primary tumor can radical resect.
Who cannot join
- Neoadjuvant therapy;Surgical contraindication.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gastrointestinal Surgery Department of the Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Jijian Wang, MD,phD, 86-23-63693511, wangjj1963@163.com
Jianbo Zhang, MD,phD, 86-23-63693510, 172329491@qq.com
About this study
Official title: Efficacy and Safety of Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma
This project aims to investigate the safety and effectiveness of gasless single-port laparoscopic-assisted radical resection (GSLR) in the treatment of rectal carcinoma.
Read the detailed description
The gasless single-port laparoscopic-assisted surgery (GSLS) is associated with rapid recovery and shorter postoperative hospital stay and no pneumoperitoneum complications occur after the operation. To our knowledge, there have been no reports about GSLS applied to the treatment of gastrointestinal cancer in the world. To explore the safety and effectiveness of GSLS in rectal cancer patients, this project plans to evaluate the operation time, cardio-pulmonary function, postoperative pain, immunologic function and restoration of bowel function after the operation.
- Conditions
- Laparoscopic Surgery
- Being tested
- gasless single-port laparoscopic surgery, conventional laparoscopic surgery
- Keywords
- gasless single-port laparoscopic surgery;rectal carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gasless single-port laparoscopic surgeryProcedure or surgery
The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system.
conventional laparoscopic surgeryProcedure or surgery
The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room.
| Study group | Role | What they receive |
|---|---|---|
| gasless single-port laparoscopic surgery | Experimental | radical resection of rectal carcinoma is performed by gasless single-port laparoscopic-assisted surgery. Receives: Procedure: gasless single-port laparoscopic surgery |
| conventional laparoscopic surgery | Sham comparator | radical resection of rectal carcinoma is performed by conventional laparoscopic surgery. Receives: Procedure: conventional laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
Estimate the pulmonary function in the perioperational period by blood gas analysis, which will be compared with comparator.The main parameter partial pressure of oxygen(PaO2)/inspired oxygen fraction(FiO2) ratio is the ratio of arterial oxygen partial pressure to fractional inspired oxygen.
Measured: Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over.
Immunologic function
Estimate the immunologic function in the perioperational period by blood lymphocyte analysis, which will be compared with comparator.The main parameter cluster of differentiation 4(CD4)/cluster of differentiation 8(CD8) ratio is the ratio of lymphocyte CD4 numbers to lymphocyte CD8 numbers.
Measured: Change from baseline CD4/CD8 ratio 7 days after operation.
Secondary outcomes (4)
Operation time
Measure the operation time, which will be compared with comparator.
Measured: at 1 day
Postoperative pain
Measure the postoperative pain after operation by numerical rating scale(NRS), which will be compared with comparator.
Measured: 72 hours after operation
Bowel function
Measure the restoration of bowel function after operation, which will be compared with comparator.The bowel function was evaluated by first flatus.
Measured: up to 1 week after operation
Number of the lymph node dissection
Measure the number of the regional lymph node dissection after operation, which will be compared with comparator.
Measured: at 1 week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Nov 2017
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jijian Wang, phD, Study chair, The Second Affiliated Hospital of Chongqing Medical UniversityYaxu Wang, phD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical UniversityYang Li, phD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical UniversityDaihua Zhu, phD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical UniversityJianbo Zhang, phD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical UniversityHaitao Gu, phD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical UniversityShiji Zhou, phD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical UniversityZhiquan Xu, Bachelor, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318185
- Sponsor's protocol ID
- 2017140
- Status last verified
- Jan 2018
- First submitted
- 20 Sep 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- 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 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma
- ClinicalTrials.gov ID
- NCT03318185
- Acronym / sponsor ID
- 2017140
- Conditions
- Laparoscopic Surgery
- Keywords
- gasless single-port laparoscopic surgery;rectal carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 23 Oct 2017 (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.
This project aims to investigate the safety and effectiveness of gasless single-port laparoscopic-assisted radical resection (GSLR) in the treatment of rectal carcinoma.
Detailed description
The gasless single-port laparoscopic-assisted surgery (GSLS) is associated with rapid recovery and shorter postoperative hospital stay and no pneumoperitoneum complications occur after the operation. To our knowledge, there have been no reports about GSLS applied to the treatment of gastrointestinal cancer in the world. To explore the safety and effectiveness of GSLS in rectal cancer patients, this project plans to evaluate the operation time, cardio-pulmonary function, postoperative pain, immunologic function and restoration of bowel function after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gasless single-port laparoscopic surgery | Experimental | Procedure: gasless single-port laparoscopic surgeryradical resection of rectal carcinoma is performed by gasless single-port laparoscopic-assisted surgery. |
| conventional laparoscopic surgery | Sham comparator | Procedure: conventional laparoscopic surgeryradical resection of rectal carcinoma is performed by conventional laparoscopic surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rectal carcinoma;The distance between tumor and anal verge is 5-15cm; The primary tumor can radical resect.
Key exclusion criteria (1 listed)
- Neoadjuvant therapy;Surgical contraindication.
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 |
|---|---|---|
| gasless single-port laparoscopic surgeryThe single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system. | Procedure or surgery | gasless single-port laparoscopic surgery |
| conventional laparoscopic surgeryThe multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room. | Procedure or surgery | conventional laparoscopic surgery |
Primary outcome
Pulmonary function
Time frame: Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over.
Estimate the pulmonary function in the perioperational period by blood gas analysis, which will be compared with comparator.The main parameter partial pressure of oxygen(PaO2)/inspired oxygen fraction(FiO2) ratio is the ratio of arterial oxygen partial pressure to fractional inspired oxygen.
Immunologic function
Time frame: Change from baseline CD4/CD8 ratio 7 days after operation.
Estimate the immunologic function in the perioperational period by blood lymphocyte analysis, which will be compared with comparator.The main parameter cluster of differentiation 4(CD4)/cluster of differentiation 8(CD8) ratio is the ratio of lymphocyte CD4 numbers to lymphocyte CD8 numbers.
4 secondary outcomes
Operation time
Time frame: at 1 day
Postoperative pain
Time frame: 72 hours after operation
Bowel function
Time frame: up to 1 week after operation
Number of the lymph node dissection
Time frame: at 1 week after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- 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.
Jijian Wang, phD study chair
The Second Affiliated Hospital of Chongqing Medical University
Yaxu Wang, phD principal investigator
The Second Affiliated Hospital of Chongqing Medical University
Yang Li, phD principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gasless single-port laparoscopic surgery and conventional laparoscopic surgery in people with Laparoscopic Surgery, run by The Second Affiliated Hospital of Chongqing Medical 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 1 inclusion and 1 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 12 Jan 2018. 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. Some participants in this study may receive a placebo. 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 Jijian Wang, phD (02363693511, wangjj1963@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function (time frame: Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over.). 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?
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 12 Jan 2018.