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This study is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer（TLSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.
At present，surgical treatments is the main means to cure colorectal cancer（CRC）.The use of four or more ports has been routine in most laparoscopic colorectal resections. However，the drawbacks are the need for added manpower, consisting of another assistant to provide counter-traction, as well as costs and the unaesthetic effects of additional ports. In order to minimize surgical trauma, improve cosmesis ,reduce manpower，single-incision laparoscopic surgery (SILS) is attracting increasing attention. But it is challenging and highly demanding techniques. Becoming proficient at three-port laparoscopic surgery can make the transition to SILS more nature.Few studies about three-port laparoscopic surgery for colorectal cancer（TLSC） have been reported currently.More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TLSC. This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 282 eligible patients will be randomly assigned to TLSC group and CLSC group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the the feasibility, safety, and potential benefits of TLSC compared with CLSC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three-port Laparoscopic Surgery | Experimental | Patients with colorectal cancer undergo three-port laparoscopic surgery. |
|
| Conventional Laparoscopic Surgery | Experimental | Patients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three-port Laparoscopic Surgery | Procedure | Patients undergo three-port laparoscopic surgery. The surgery will be completed by a surgeon and a camera-person without another assistant. The surgeon will adjust surgical position to expose the operative field with the help of gravity. All the orther operative procedures are the same as conventional laparoscopic surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Early morbidity rate | morbidity rate 30 days after surgery | 30 days 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 | Contact | +86-18917762018 | rjzhaoren@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Zhang, MD | Ruijin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25006515 | Background | Tawfik Amin A, Elsaba TM, Amira G. Three ports laparoscopic resection for colorectal cancer: a step on refining of reduced port surgery. ISRN Surg. 2014 Mar 12;2014:781549. doi: 10.1155/2014/781549. eCollection 2014. | |
| 21234638 | Background | Seow-En I, Tan KY, Mohd Daud MA, Seow-Choen F. Traditional laparoscopic colorectal resections can be performed effectively using a three-port technique. Tech Coloproctol. 2011 Mar;15(1):91-3. doi: 10.1007/s10151-010-0660-6. Epub 2011 Jan 14. No abstract available. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| Conventional Laparoscopic Surgery | Procedure | Patients undergo conventional laparoscopic surgery（4 or more ports）.The surgery will be routinely completed by a surgeon，a camera-person and another assistant to provide counter-traction. |
|
| Lymph node detection | Lymph nodes harvested（numbers） | 14 days after surgery |
| Proximal resection margin | Length of proximal margin （centimeters，cm） | 14 days after surgery |
| Distal resection margin | Length of distal margin （centimeters，cm） | 14 days after surgery |
| Length of stay | Duration of hospital stay（days after surgery） | 1-14 days after surgery |
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery） | 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 | 1-3 days after surgery |
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months after surgery |
| 5-year overall survival rate | 5-year overall survival rate | 60 months after surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |