Colorectal CancerPhase 2NCT02117557
Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
A Phase 2 study testing Single incision laparoscopic surgery and Conventional laparoscopic surgery in people with Colorectal Cancer, run by Guoxin Li at 1 site in China.
Trial summary
Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated. 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?
- Single incision laparoscopic surgery and Conventional laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Apr 2022
- Phase
- Phase 2
- 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 10- to 30-cm from the anal verge)
- Pathological rectosigmoid carcinoma
- Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
- Tumor size of 5 cm or less; 6) ECOG score is 0-1
- ASA socre 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
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515
Guoxin Li, M.D.,PH.D., +86-138-0277-1450, gzliguoxin@163.com
Guoxin Li, M.D.,PH.D.
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
- Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated.
- In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring.
- However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed.
- Conditions
- Colorectal Cancer
- Being tested
- Single incision laparoscopic surgery, Conventional laparoscopic surgery
- Keywords
- Single-incision, Laparoscopy, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single incision laparoscopic surgeryProcedure or surgery
Also called SILS
Conventional laparoscopic surgeryProcedure or surgery
Also called CLS
| Study group | Role | What they receive |
|---|---|---|
| Single incision laparoscopic surgery | Experimental | Transumbilical single incision laparoscopic surgery will be performed for patients in this group.And addition of only one trocar through the stoma for drainage tube is allowed. Receives: Procedure: Single incision laparoscopic surgery |
| 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 (8)
Operative outcomes
Operative time, estimated blood loss and incision length are recorded.
Measured: intraoperative
Pathological outecomes
Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.
Measured: 5 days
Postoperative recovery course
Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course.
Measured: 14 days
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.
Measured: 14 days
Cosmetic assessment
Cosmetic assessment is perform using body image scale and cosmetic scale.
Measured: 14 days
3-year disease free survival rate
Measured: 36 months
5-year overall survival rate
Measured: 60 months
Inflammatory and immune response
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 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2017 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guoxin Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guoxin Li, Nanfang Hospital, Southern Medical University
- Investigators
- Guoxin Li, M.D., PH.D., Principal investigator, Nanfang Hospital, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117557
- Sponsor's protocol ID
- NFGS-SILS-01
- Status last verified
- Apr 2014
- First submitted
- 16 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bucher P, Pugin F, Morel P. Single-port access laparoscopic radical left colectomy in humans. Dis Colon Rectum. 2009 Oct;52(10):1797-801. doi: 10.1007/DCR.0b013e3181b551ce.
PubMed 19966617Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.
PubMed 20734083Lim SW, Kim HJ, Kim CH, Huh JW, Kim YJ, Kim HR. Umbilical incision laparoscopic colectomy with one additional port for colorectal cancer. Tech Coloproctol. 2013 Apr;17(2):193-9. doi: 10.1007/s10151-012-0900-z. Epub 2012 Sep 19.
PubMed 22991135Hirano Y, Hattori M, Douden K, Shimizu S, Sato Y, Maeda K, Hashizume Y. Single-incision plus one port laparoscopic anterior resection for rectal cancer as a reduced port surgery. Scand J Surg. 2012;101(4):283-6. doi: 10.1177/145749691210100411.
PubMed 23238505Zhang X, Yuan H, Tan Z, Li G, Xu Z, Zhou J, Fu J, Wu M, Xi J, Wang Y. Long-term outcomes of single-incision plus one-port laparoscopic surgery versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial. BMC Cancer. 2023 Dec 7;23(1):1204. doi: 10.1186/s12885-023-11500-2.
PubMed 38062421Wang Y, Deng H, Mou T, Li J, Liu H, Zhou H, Li G. Short-term outcomes of single-incision plus one-port laparoscopic versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial. Surg Endosc. 2019 Mar;33(3):840-848. doi: 10.1007/s00464-018-6350-6. Epub 2018 Jul 13.
PubMed 30006846Wang Y, Liu R, Zhang Z, Xue Q, Yan J, Yu J, Liu H, Zhao L, Mou T, Deng H, Li G. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial. Trials. 2015 Nov 30;16:539. doi: 10.1186/s13063-015-1067-5.
PubMed 26620555
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02117557
- Acronym / sponsor ID
- NFGS-SILS-01
- Conditions
- Colorectal Cancer
- Keywords
- Single-incision, Laparoscopy, Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Guoxin LiUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 21 Apr 2014 (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.
- Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated.
- In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring.
- However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single incision laparoscopic surgery | Experimental | Procedure: Single incision laparoscopic surgeryTransumbilical single incision laparoscopic surgery will be performed for patients in this group.And addition of only one trocar through the stoma for drainage tube is allowed. |
| 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 (7 listed)
- 18 years < age < 80 years
- Tumor located in rectosigmoid (defined as 10- to 30-cm from the anal verge)
- Pathological rectosigmoid carcinoma
- Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
- Tumor size of 5 cm or less; 6) ECOG score is 0-1
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 |
|---|---|---|
| Single incision laparoscopic surgeryAlso: SILS | Procedure or surgery | Single incision laparoscopic surgery |
| Conventional laparoscopic surgeryAlso: CLS | 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,
8 secondary outcomes
Operative outcomes
Time frame: intraoperative
Pathological outecomes
Time frame: 5 days
Postoperative recovery course
Time frame: 14 days
Pain score
Time frame: 14 days
Cosmetic assessment
Time frame: 14 days
3-year disease free survival rate
Time frame: 36 months
5-year overall survival rate
Time frame: 60 months
Inflammatory and immune response
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 21 Apr 2014.
- Background: PubMed 19966617Bucher P, Pugin F, Morel P. Single-port access laparoscopic radical left colectomy in humans. Dis Colon Rectum. 2009 Oct;52(10):1797-801. doi: 10.1007/DCR.0b013e3181b551ce.
- Background: PubMed 20734083Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.
- Background: PubMed 22991135Lim SW, Kim HJ, Kim CH, Huh JW, Kim YJ, Kim HR. Umbilical incision laparoscopic colectomy with one additional port for colorectal cancer. Tech Coloproctol. 2013 Apr;17(2):193-9. doi: 10.1007/s10151-012-0900-z. Epub 2012 Sep 19.
- Background: PubMed 23238505Hirano Y, Hattori M, Douden K, Shimizu S, Sato Y, Maeda K, Hashizume Y. Single-incision plus one port laparoscopic anterior resection for rectal cancer as a reduced port surgery. Scand J Surg. 2012;101(4):283-6. doi: 10.1177/145749691210100411.
- Derived from this study: PubMed 38062421Zhang X, Yuan H, Tan Z, Li G, Xu Z, Zhou J, Fu J, Wu M, Xi J, Wang Y. Long-term outcomes of single-incision plus one-port laparoscopic surgery versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial. BMC Cancer. 2023 Dec 7;23(1):1204. doi: 10.1186/s12885-023-11500-2.
- Derived from this study: PubMed 30006846Wang Y, Deng H, Mou T, Li J, Liu H, Zhou H, Li G. Short-term outcomes of single-incision plus one-port laparoscopic versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial. Surg Endosc. 2019 Mar;33(3):840-848. doi: 10.1007/s00464-018-6350-6. Epub 2018 Jul 13.
- Derived from this study: PubMed 26620555Wang Y, Liu R, Zhang Z, Xue Q, Yan J, Yu J, Liu H, Zhao L, Mou T, Deng H, Li G. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial. Trials. 2015 Nov 30;16:539. doi: 10.1186/s13063-015-1067-5.
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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.
Guoxin Li, M.D., PH.D. principal investigator
Nanfang Hospital, Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single incision laparoscopic surgery and Conventional laparoscopic surgery in people with Colorectal Cancer, run by Guoxin Li 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 7 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 21 Apr 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Guoxin Li, M.D., PH.D. (+86-138-0277-1450, gzliguoxin@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?
On the ClinicalTrials.gov record for NCT02117557, which also lists 7 linked publications.
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 21 Apr 2014.