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Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery.
Design: randomized, prospective clinical study Patients: 40 patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SILS-group | Experimental | 20 patients undergoing Single Incision Laparoscopic Surgery |
|
| CLS-group | No Intervention | 20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Incision Laparoscopic Surgery | Procedure | Single incision laparoscopic surgery for rectal cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| morbidity | The purpose of this study is to compare 30-days postoperative morbidity between the two groups | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| immunology | to compare results of blood-samples (C-reactive protein, leucocyte-count and interleukin-6) 72 hours postoperatively between the two groups | 72 hours postoperatively |
| postoperative outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroentestinal Surgery, Hvidovre Hospital | Hvidovre | DK-2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25380743 | Derived | Bulut O, Aslak KK, Levic K, Nielsen CB, Romer E, Sorensen S, Christensen IJ, Nielsen HJ. A randomized pilot study on single-port versus conventional laparoscopic rectal surgery: effects on postoperative pain and the stress response to surgery. Tech Coloproctol. 2015 Jan;19(1):11-22. doi: 10.1007/s10151-014-1237-6. Epub 2014 Nov 8. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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to compare postoperative results (postoperative pain, time to bowel function, time to regain full diet and mobilisation) between the two groups.
| 5 days postoperatively |
| oncology | Comparison of the oncological results (quality of specimen, completeness of mesorectal fascia, circumferential resection margin, number of harvested lymphnodes, TNM-classification) between the two groups. | 30 days |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |