Colorectal CancerPhase 3NCT02635503
Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
A Phase 3 study testing transrectal specimen extraction and Conventional laparoscopic surgery in people with Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- transrectal specimen extraction and Conventional laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2025
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years < age < 80 years
- Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)
- Pathological rectosigmoid adenocarcinoma
- Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
- Tumor size of 6 cm or less;
- Eastern Cooperative Oncology Group (ECOG) score is 0-1
- American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
- Informed consent
Who cannot join
- Body mass index (BMI) >30 kg/m2
- Pregnant woman or lactating woman
- Severe mental disease
- Previous abdominal surgery
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- Requirement of simultaneous surgery for other disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, Beijing Municipality, 100021
Jianwei Liang, M.D., +86-130-7119-7461, liangjw1976@126.com
Zhixiang Zhou, M.D., +86-139-1123-2981, Dr_zhouzx@163.com
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer
The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.
Read the detailed description
Further study details as provided by Chinese Academy of Medical Sciences.
- Conditions
- Colorectal Cancer
- Being tested
- transrectal specimen extraction, Conventional laparoscopic surgery
- Keywords
- colorectal cancer, laparoscopic surgery, natural orifice specimen extraction, Inflammatory response
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transrectal specimen extractionProcedure or surgery
Also called NOSE
After mobilization of bowel and dissection of lymph nodes, a cross clamp was placed distal to the tumor. Distal rectum was transected after fully disinfecting rectal lumen by 10% povidone-iodine. An anvil head attached to circular stapling device was put into abdominal cavity through rectal stump, and put into colon lumen through a longitudinal incision, then the proximal colon was transected in close proximity to the upper pole of incision by a linear stapling device. During specimen extraction though the rectum, a disposable sterile protective cover was used to avoid cancer cell exfoliation and implantation. The rectal opening was reclosed by a linear stapler. End-to-end colorectal anastomosis was performed with a circular stapler using the double-stapling technique.
Conventional laparoscopic surgeryProcedure or surgery
Also called CLS
High ligation of inferior mesenteric vessel , mobilization of bowel, and dissection of lymph nodes were performed laparoscopically, and total mesorectal excision with nerve-sparing technique was followed for rectal cancer. Conventional laparoscopic-assisted surgery (CLS), a small incision with a 3-7cm length was made in hypogastrium, transection of rectum was completed through abdominal incision, then the specimen was removed and the bowel was prepared for anastomosis. The anastomosis for all rectal cancer and most of sigmoid colon cancer was performed by a double-stapling technique following open resection.
| Study group | Role | What they receive |
|---|---|---|
| transrectal specimen extraction | Experimental | Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group. Receives: Procedure: transrectal specimen extraction |
| Conventional laparoscopic surgery | Active comparator | Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group. Receives: Procedure: Conventional laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early morbidity rate
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
Measured: 30 days
Secondary outcomes (6)
Duration of the intervention
Duration of surgery.
Measured: 1 day
Peritoneal bacterial contamination
Peritoneal fluid samples were collected under sterile conditions at the end of the procedure and sent for gram stain as well as anaerobic, aerobic, and fungal cultures.We assess the contamination rate of peritoneal fluid in the two interventions.
Measured: 1 day
Pain score
Recording of the needed analgesia guided by pain score
Measured: 14 days
3-year disease free survival rate
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
Measured: 3 years
5-year overall survival rate
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
Measured: 5 years
Plasma levels of several cytokines after colorectal cancer surgery
We have measured and compared perioperative plasma levels of interleukin-2, interleukin-6, interleukin-8, C-reactive protein and procalcitonin in the two group sample.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhixiang Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Zhixiang Zhou, M.D., Principal investigator, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635503
- Sponsor's protocol ID
- NCC2015SF-04
- Status last verified
- Sep 2016
- First submitted
- 30 Nov 2015
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer
- ClinicalTrials.gov ID
- NCT02635503
- Acronym / sponsor ID
- NCC2015SF-04
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, laparoscopic surgery, natural orifice specimen extraction, Inflammatory response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Dec 2015 (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 purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.
Detailed description
Further study details as provided by Chinese Academy of Medical Sciences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transrectal specimen extraction | Experimental | Procedure: transrectal specimen extractionLaparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group. |
| Conventional laparoscopic surgery | Active comparator | Procedure: Conventional laparoscopic surgeryConventional laparoscopic surgery for colorectal cancer will be performed for patients in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years < age < 80 years
- Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)
- Pathological rectosigmoid adenocarcinoma
- Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
- Tumor size of 6 cm or less;
Key exclusion criteria (6 listed)
- Body mass index (BMI) >30 kg/m2
- Pregnant woman or lactating woman
- Severe mental disease
- Previous abdominal surgery
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
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 |
|---|---|---|
| transrectal specimen extractionAlso: NOSEAfter mobilization of bowel and dissection of lymph nodes, a cross clamp was placed distal to the tumor. Distal rectum was transected after fully disinfecting rectal lumen by 10% povidone-iodine. An anvil head attached to circular stapling device was put into abdominal cavity through rectal stump, and put into colon lumen through a longitudinal incision, then the proximal colon was transected in close proximity to the upper pole of incision by a linear stapling device. During specimen extraction though the rectum, a disposable sterile protective cover was used to avoid cancer cell exfoliation and implantation. The rectal opening was reclosed by a linear stapler. End-to-end colorectal anastomosis was performed with a circular stapler using the double-stapling technique. | Procedure or surgery | transrectal specimen extraction |
| Conventional laparoscopic surgeryAlso: CLSHigh ligation of inferior mesenteric vessel , mobilization of bowel, and dissection of lymph nodes were performed laparoscopically, and total mesorectal excision with nerve-sparing technique was followed for rectal cancer. Conventional laparoscopic-assisted surgery (CLS), a small incision with a 3-7cm length was made in hypogastrium, transection of rectum was completed through abdominal incision, then the specimen was removed and the bowel was prepared for anastomosis. The anastomosis for all rectal cancer and most of sigmoid colon cancer was performed by a double-stapling technique following open resection. | Procedure or surgery | Conventional laparoscopic surgery |
Primary outcome
Early morbidity rate
Time frame: 30 days
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
6 secondary outcomes
Duration of the intervention
Time frame: 1 day
Peritoneal bacterial contamination
Time frame: 1 day
Pain score
Time frame: 14 days
3-year disease free survival rate
Time frame: 3 years
5-year overall survival rate
Time frame: 5 years
Plasma levels of several cytokines after colorectal cancer surgery
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- 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.
Zhixiang Zhou, M.D. principal investigator
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transrectal specimen extraction and Conventional laparoscopic surgery in people with Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 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 2 Sep 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhixiang Zhou, M.D. (+86-139-1123-2981, Dr_zhouzx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early morbidity rate (time frame: 30 days). 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 2 Sep 2016.