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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Seoul National University Boramae Hospital | OTHER |
| National Cancer Center, Korea | OTHER_GOV |
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Through the use of a novel asymmetrical linear stapler (NALS, Meditulip co. Ltd.), we aim to prove that true distal margins greater than 1cm may be harvested more readily and easily compared to the conventional staplers. The study is designed as a pilot RCT of 30 patients in each group, with the primary outcome of distal margin length >1cm. Secondary outcomes include anastomosis dehiscence and time taken to harvest the distal margin.
Current evidence indicates distal margins of greater than 1cm from the tumor is necessary for superior oncologic outcomes. In middle to lower rectal cancer, where the tumor is close to the anus, sparing the anus whilst securing such a margin may prove difficult.
Failure to secure sufficient margin length may end up in cancer recurrence, but inaccurate assessment of the margin status may also cause further unnecessary resection or failure to spare the anus.
The novel asymmetrical linear stapler was designed specifically with this problem in mind, and one row of stapling was removed from the specimen side to allow easier harvesting of a undisrupted distal margin tissue for pathological evaluation.
This study is a pilot RCT of 30 patients each in the novel stapler group and control group, to prove the non-inferiority in safety and superiority in harvesting the distal margin (assessed by length of margin and time to harvest).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel asymmetrical linear stapler | Experimental | Rectal cancer patients randomized to this group will use the novel asymmetrical linear stapler for distal rectum transection, and with 2 rows of stapler lines instead of 3, sufficient tissue is left on the specimen side to harvest the true distal margin for accurate pathological evaluation. |
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| Control | Active Comparator | Rectal cancer patients in the control group will use the conventional Signia™ stapler (Medtronic co.) as routinely used in the centers involved with the study, which has triple stapling technology (3 rows of stapler lines on both sides of transection) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel asymmetrical linear stapler | Device | Novel asymmetrical linear stapler |
|
| Measure | Description | Time Frame |
|---|---|---|
| True distal margin length > 1cm | True distal margin: The length of tissue from the distal edge of the specimen to the distal tumor margin in the surgical specimen | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Early anastomosis leakage | Anastomosis leakage within 30 days of surgery will be documented and reported as an outcome. The International Study Group of Rectal Cancer definition of anastomosis leakage will be used to define the outcome (defect of the intestinal wall at the anastomotic site leading to a communication between the intra- and extraluminal compartments, requiring NPO or other intervention). Patients that have clinical signs of infection (fever, sepsis, inflammatory lab change or abdominal drain color change) with either fluid collection near the anastomosis or an anastomosis defect on CT imaging will be diagnosed as having anastomosis leakage. CT scans will not be taken routinely, but will be performed when signs of infection (such as abdominal tenderness or high fever) are present. Severity of the anastomosis leak will be graded according to the International Study Group of Rectal Cancer grading system (grade A, B, C) depending on the necessary intervention (none, non-surgical or surgical). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Hyun Park, MD | Contact | +82 10 7233 3820 | parkjhyun719@naver.com | |
| Seung-Bum Ryoo, MD PhD | Contact | sbryoomd@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongro-gu | 03080 | South Korea |
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| Kyungpook National University Chilgok Hospital |
| OTHER |
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| Signia™ | Device | Signia™ |
|
| From randomization until the date of first documented sign of leakage, assessed up to 30 days |
| Time to harvest margin | Time (seconds) taken to harvest the distal margin from the specimen for frozen section biopsy | Intraoperative (from the beginning of frozen section specimen harvest until the acquirement is completed. This process will be timed by a member of the surgical team using a timer.) |
| Specimen integrity | The pathologist evaluation of whether the whole thickness of bowel was harvested in the distal margin frozen section biopsy. This will be requested and reviewed, reported in the final pathologist report. | Intraoperative (at the time point of the frozen section pathology report) |
| Sphincter preservation rate | Although all eligible candidates will be planned for sphincter-preserving surgery, there are some cases where the distal margin is not suffice for an R0 resection and thus receive non-sphincter preserving surgery. The incidence of such non-sphincter preserving surgery (example: abdominoperineal resection) will be reported. | From randomization until the end of clinical data collection, assessed up to 120 days. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| 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 |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
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