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| Name | Class |
|---|---|
| Katsunari Takifuji | UNKNOWN |
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The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.
Laparoscopic colon surgery is less invasive and more cosmetic than open surgery. But the extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in laparoscopic colon surgery. The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision. The investigators hypothesize that the use of the midline extraction incision in laparoscopic colon surgery will result in more cosmetic effect and better quality of life compared to the off-midline extraction incision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midline incision | Experimental | The extraction-site incision in laparoscopic colectomy is middline |
|
| off-midline incision | Active Comparator | The extraction-site incision in laparoscopic colectomy is off-middline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midline incision or off-midline incision | Other | Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| cosmetic effect | Scar assessment score on the patient and observer scar assessment scale(POSAS) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Questionnaire on the SF-36 v2 acute | 7 days, 14 days and 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernia | Numbers of participants with incisional hernia | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katsunari Takifuji | Contact | 073-447-2300 | 5112 | takifuji@wakayama-med.ac.jp |
| Tsukasa Hotta | Contact | 073-447-2300 | 5112 | hotta@wakayama-med.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| HIroki Yamaue, Chief prof. | Second Department of Surgery, Wakayama Medical University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23375702 | Background | Samia H, Lawrence J, Nobel T, Stein S, Champagne BJ, Delaney CP. Extraction site location and incisional hernias after laparoscopic colorectal surgery: should we be avoiding the midline? Am J Surg. 2013 Mar;205(3):264-7; discussion 268. doi: 10.1016/j.amjsurg.2013.01.006. Epub 2013 Jan 31. | |
| 18347858 | Background |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Singh R, Omiccioli A, Hegge S, McKinley C. Does the extraction-site location in laparoscopic colorectal surgery have an impact on incisional hernia rates? Surg Endosc. 2008 Dec;22(12):2596-600. doi: 10.1007/s00464-008-9845-8. Epub 2008 Mar 18. |
| 22580878 | Background | Lee L, Mappin-Kasirer B, Sender Liberman A, Stein B, Charlebois P, Vassiliou M, Fried GM, Feldman LS. High incidence of symptomatic incisional hernia after midline extraction in laparoscopic colon resection. Surg Endosc. 2012 Nov;26(11):3180-5. doi: 10.1007/s00464-012-2311-7. Epub 2012 May 12. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |