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This clinical trial aims to evaluate the safety and feasibility of mid-line fascial suturing using MONOFIX sutures in patients undergoing minimally invasive surgery for colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monofix | Experimental | In patients who underwent laparoscopic colorectal cancer surgery, the fascial closure of the midline incision was performed using a running suture type with Monofix, one of the barbed sutures. |
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| Control group | No Intervention | In patients who underwent laparoscopic colorectal cancer surgery, the fascial closure of the midline incision was performed using an interrupted suture type with PDS-II, one of the monofilament sutures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monofix | Device | a new absorbable barbed suture device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernia | Incisional hernia diagnosed by CT scan. | 18 months from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Wound infection | In cases where microorganisms were identified in the wound culture results. | 1 month from surgery |
| Wound bleeding | In cases where bleeding was visually observed from the wound or a hematoma was observed on the CT scan. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Gangnam | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38877993 | Derived | Pyo DH, Yun SH, Lee WY. A prospective single-arm clinical trial to assess the safety and efficacy of monofilament polydioxanone barbed suture, MONOFIX(R), on abdominal fascial closure. World J Surg. 2024 Jul;48(7):1674-1680. doi: 10.1002/wjs.12247. Epub 2024 Jun 15. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 1 month from surgery |
| Wound dehiscence | In cases where the fascial closure was incomplete, causing part of the abdominal organs to protrude outside the abdomen, requiring surgical treatment. | 1 month from surgery |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |