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| Name | Class |
|---|---|
| Dongfang Hospital Affiliated to Tongji University | OTHER |
| Fudan University | OTHER |
| Changhai Hospital | OTHER |
| Shengjing Hospital |
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This study is designed to investigate long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) compared to conventional laparoscopic surgery (CLS) for colorectal cancer.
In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-incision Laparoscopic Surgery | Experimental | Patients with colorectal cancer undergo single-incision laparoscopic surgery. |
|
| Conventional Laparoscopic Surgery | Active Comparator | Patients with colorectal cancer undergo conventional laparoscopic surgery（3~5 ports）. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-incision Laparoscopic Surgery | Procedure | In this group，the surgery is performed through a single incision. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time（minutes） | intraoperative |
| Intraoperative blood loss | Estimated blood loss（milliliters，ml） | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ren Zhao, MD, PHD | Contact | +8618917762018 | zhaorensurgeon@aliyun.com | |
| Kun Liu, MD | Contact | +8618121263082 | lookiere@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ren Zhao, MD, PHD | Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Chun Song, MD | Dongfang Hospital Affiliated to Tongji University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 940th Hospital of Joint Logistic Support Force of Chinese of PLA | Recruiting | Lanzhou | Gansu | 730050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30303873 | Background | Maggiori L, Tuech JJ, Cotte E, Lelong B, Denost Q, Karoui M, Vicaut E, Panis Y. Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):740-746. doi: 10.1097/SLA.0000000000002836. | |
| 32209897 | Background |
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| OTHER |
| RenJi Hospital | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| The General Hospital of Western Theater Command | OTHER |
| Shanghai Jiao Tong University School of Medicine | OTHER |
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|
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| Conventional Laparoscopic Surgery | Procedure | In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions. |
|
|
| Incision length | Incision length（centimeters，cm） | intraoperative |
| Total incision length | The sum of all incision lengths（centimeters，cm） | intraoperative |
| Conversion rate | The proportion of converted to laparotomy and added trocars（%） | intraoperative |
| Length of stay | The postoperative day when patients complied with the predefined discharge criteria（days after surgery） | 1-14 days after surgery |
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery） | 1-14 days after surgery |
| Early morbidity rate | morbidity rate 30 days after surgery | 30 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 | 1-3 days after surgery |
| Tumor size | The diameter of tumors（centimeters，cm） | 14 days after surgery |
| Incisal margin | Length of proximal and distal margin （centimeters，cm） | 14 days after surgery |
| Lymph node detection | Lymph nodes harvested（numbers） | 14 days after surgery |
| Cosmetic effect | Assessed using a "Beauty Questionnaire" evaluating patient's satisfaction according to a 5-scale score, ranging from ''Not satisfied at all'' to ''Very satisfied'' | 1 month, 6 months and 1 year after surgery |
| The quality of life-Core | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | 1 month, 6 months and 1 year after surgery |
| The quality of life-Colorectal | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) | 1 month, 6 months and 1 year after surgery |
| 5-year overall survival rate | 5-year overall survival rate | 60 months after surgery |
| Ye Xu, MD | Shanghai Cancer Center | Study Director |
| Liqiang Hao, MD | Changhai Hospital | Study Director |
| Hong Zhang, MD | Shengjing Hospital | Study Director |
| Hong Zhou, MD | RenJi Hospital | Study Director |
| Qingtong Zhang, MD | Liaoning Cancer Hospital & Institute | Study Director |
| Shiliang Tu, MD | Zhejiang Provincial People's Hospital | Study Director |
| Xiaoqiao Zhang, MD | Shandong Provincial Hospital | Study Director |
| Lin Zhang, MD | The General Hospital of Western Theater Command | Study Director |
| Feng Gao, MD | The 940th Hospital of Joint Logistic Support Force of Chinese of PLA | Study Director |
| Shengjing Hospital | Recruiting | Shenyang | Liaoning | 110004 | China |
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| Liaoning Tumor Hospital & Institute | Recruiting | Shenyang | Liaoning | 110801 | China |
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| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | 250021 | China |
|
| The General Hospital of Western Theater Command | Recruiting | Chengdu | Sichuan | 610083 | China |
|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
|
| Shanghai Cancer Center | Recruiting | Shanghai | 200032 | China |
|
| Dongfang Hospital Affiliated to Tongji University | Recruiting | Shanghai | 200120 | China |
|
| RenJi Hospital | Recruiting | Shanghai | 200127 | China |
|
| Changhai Hospital | Recruiting | Shanghai | 200438 | China |
|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | 201801 | China |
|
| Lee YS, Kim JH, Kim HJ, Lee SC, Kang BM, Kim CW, Lim SW, Lee SH, Kim JG. Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial. Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882. |
| 35799145 | Derived | Song Z, Liu K, Zhang T, Wang B, Shi Y, Jiang Y, Wang C, Chen X, Ji X, Zhao R. Oncologic outcomes of single-incision laparoscopic surgery versus conventional laparoscopic surgery for colorectal cancer (CSILS): study protocol for a multicentre, prospective, open-label, noninferiority, randomized controlled trial. BMC Cancer. 2022 Jul 7;22(1):743. doi: 10.1186/s12885-022-09821-9. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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