Laparoscopic Colorectal SurgerySILCSNCT03151733
Single Incision Laparoscopic Colorectal Surgery
A study testing single incision laparoscopic surgery and conventional laparoscopic surgery in people with Laparoscopic Colorectal Surgery, run by Ruijin Hospital at 1 site in China.
Trial summary
Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Colorectal Surgery
- What is being tested?
- single incision 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
- 28 Jun 2017to 29 Jun 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years < age < 80 years
- Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)
- Pathological colorectal carcinoma
- Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual
- Tumor size of 5 cm or less
- ECOG score is 0-1
- ASA score is Ⅰ-Ⅲ
- Informed consent
Who cannot join
- Body mass index (BMI) >30 kg/m2
- The lower border of the tumor is located distal to the peritoneal reflection
- Pregnant woman or lactating woman
- Severe mental disease
- Previous abdominal surgery（except appendectomy and cholecystotomy）
- 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.
About this study
Official title: Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease
Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.
Read the detailed description
The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.
- Conditions
- Laparoscopic Colorectal Surgery
- Being tested
- single incision laparoscopic surgery, conventional laparoscopic surgery
- Keywords
- SILS, 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
Patients undergo single incision laparoscopic surgery
conventional laparoscopic surgeryProcedure or surgery
Patients undergo conventional laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| single incision laparoscopic surgery | Experimental | patients with colorectal cancer and undergo single incision laparoscopic surgery Receives: Procedure: single incision laparoscopic surgery |
| Conventional laparoscopic surgery | Placebo comparator | patients with colorectal cancer and undergo 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.
Early morbidity rate
morbidity rate 30 days after surgery
Measured: 30 days
Secondary outcomes (11)
Operative time
Operative time（minutes）
Measured: intraoperative
Intraoperative blood loss
Estimated blood loss（milliliters，ml）
Measured: intraoperative
Incision length
Incision length（centimeters，cm）
Measured: intraoperative
Lymph node detection
Lymph nodes harvested（numbers）
Measured: 14 days after surgery
Incisal margin
Length of proximal and distal margin （centimeters，cm）
Measured: 14 days after surgery
Tumor size
The diameter of tumors（centimeters，cm）
Measured: 14 days after surgery
Length of stay
Duration of hospital stay（days after surgery）
Measured: 1-14 days after surgery
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
Measured: 1-14 days after surgery
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge
Measured: 1-3 days after surgery
3-year disease free survival rate
3-year disease free survival rate
Measured: 36 months after surgery
5-year overall survival rate
5-year overall survival rate
Measured: 60 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start28 Jun 2017
- Primary completion29 Jun 2019
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Ren, Ruijin Hospital
- Investigators
- Liu Kun, MD, Study chair, ruijin hospitla North
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151733
- Sponsor's protocol ID
- RJ-SILS-CRC2017
- Other IDs
- SHSDC
- Acronym
- SILCS
- Status last verified
- Dec 2024
- First submitted
- 20 Mar 2017
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aldeghaither S, Zubaidi A, Alkhayal K, Al-Obaid O. Single-incision laparoscopic colorectal surgery: a report of 33 cases in Saudi Arabia. Ann Saudi Med. 2016 Jul-Aug;36(4):282-7. doi: 10.5144/0256-4947.2016.282.
PubMed 27478914Song Z, Liu K, Li Y, Shi Y, Jiang Y, Wang C, Chen X, Zhang T, Ji X, Zhao R. Short-Term Outcomes of Single-Incision Laparoscopic Surgery for Colorectal Cancer: A Single-Center, Open-Label, Non-Inferiority, Randomized Clinical Trial. Front Oncol. 2021 Oct 25;11:762147. doi: 10.3389/fonc.2021.762147. eCollection 2021.
PubMed 34760706Song Z, Li Y, Liu K, Jiang Y, Shi Y, Ji X, Zhang T, Wu H, Shi Y, Zhao R. Clinical and oncologic outcomes of single-incision laparoscopic surgery for right colon cancer: a propensity score matching analysis. Surg Endosc. 2019 Apr;33(4):1117-1123. doi: 10.1007/s00464-018-6370-2. Epub 2018 Jul 24.
PubMed 30043168
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease
- ClinicalTrials.gov ID
- NCT03151733
- Acronym / sponsor ID
- SILCS / RJ-SILS-CRC2017
- Conditions
- Laparoscopic Colorectal Surgery
- Keywords
- SILS, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 12 May 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.
Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.
Detailed description
The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.
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 surgerypatients with colorectal cancer and undergo single incision laparoscopic surgery |
| Conventional laparoscopic surgery | Placebo comparator | Procedure: conventional laparoscopic surgerypatients with colorectal cancer and undergo conventional laparoscopic surgery |
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 colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)
- Pathological colorectal carcinoma
- Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual
- Tumor size of 5 cm or less
Key exclusion criteria (7 listed)
- Body mass index (BMI) >30 kg/m2
- The lower border of the tumor is located distal to the peritoneal reflection
- Pregnant woman or lactating woman
- Severe mental disease
- Previous abdominal surgery（except appendectomy and cholecystotomy）
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 surgeryPatients undergo single incision laparoscopic surgery | Procedure or surgery | single incision laparoscopic surgery |
| conventional laparoscopic surgeryPatients undergo conventional laparoscopic surgery | Procedure or surgery | Conventional laparoscopic surgery |
Primary outcome
Early morbidity rate
Time frame: 30 days
morbidity rate 30 days after surgery
11 secondary outcomes
Operative time
Time frame: intraoperative
Intraoperative blood loss
Time frame: intraoperative
Incision length
Time frame: intraoperative
Lymph node detection
Time frame: 14 days after surgery
Incisal margin
Time frame: 14 days after surgery
Tumor size
Time frame: 14 days after surgery
Length of stay
Time frame: 1-14 days after surgery
Postoperative recovery course
Time frame: 1-14 days after surgery
Pain score
Time frame: 1-3 days after surgery
3-year disease free survival rate
Time frame: 36 months after surgery
5-year overall survival rate
Time frame: 60 months after surgery
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 Dec 2024.
- Results publication: PubMed 27478914Aldeghaither S, Zubaidi A, Alkhayal K, Al-Obaid O. Single-incision laparoscopic colorectal surgery: a report of 33 cases in Saudi Arabia. Ann Saudi Med. 2016 Jul-Aug;36(4):282-7. doi: 10.5144/0256-4947.2016.282.
- Derived from this study: PubMed 34760706Song Z, Liu K, Li Y, Shi Y, Jiang Y, Wang C, Chen X, Zhang T, Ji X, Zhao R. Short-Term Outcomes of Single-Incision Laparoscopic Surgery for Colorectal Cancer: A Single-Center, Open-Label, Non-Inferiority, Randomized Clinical Trial. Front Oncol. 2021 Oct 25;11:762147. doi: 10.3389/fonc.2021.762147. eCollection 2021.
- Derived from this study: PubMed 30043168Song Z, Li Y, Liu K, Jiang Y, Shi Y, Ji X, Zhang T, Wu H, Shi Y, Zhao R. Clinical and oncologic outcomes of single-incision laparoscopic surgery for right colon cancer: a propensity score matching analysis. Surg Endosc. 2019 Apr;33(4):1117-1123. doi: 10.1007/s00464-018-6370-2. Epub 2018 Jul 24.
- Individual participant dataSharing planned: No
Related trials for Laparoscopic Colorectal Surgery
RecruitingPhase 3
Intravenous Lidocaine Plus Port-Site Ropivacaine for Recovery After Laparoscopic Surgery
Intravenous Lidocaine, Laparoscopic Surgery
Recruiting
Quality of Recovery After Colorectal Surgery (Robots vs Laparoscopic)
Recovery Outcomes
Recruiting
Effect of Oral Laxative Use Before Colorectal Surgery on Intraoperative Surgical Difficulty
Colorectal Diseases, Mechanical Bowel Preparation
Active, not recruitingPhase 1/2
Opioid-Free Anesthesia in Colorectal Surgery, 2025 (OFA-CRC-2025)
Pain Management, Colorectal Surgery
RecruitingObservational study
Internal Jugular Vein Collapsibility Index as a Predictor of Hypotension
Intraoperative Hypotension
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.
Liu Kun, MD study chair
ruijin hospitla North
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single incision laparoscopic surgery and conventional laparoscopic surgery in people with Laparoscopic Colorectal Surgery, run by Ruijin Hospital 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 7 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 Dec 2024. 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?
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?
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 NCT03151733, which also lists 3 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 10 Dec 2024.