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Investigators will compare the incidence of incisional hernia in women who underwent midline laparotomy whose abdominal fascia was closed with barbed suture vs. conventional non-barbed suture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Abdominal fascia will be closed with barbed suture. |
|
| Control | Active Comparator | Abdominal fascia will be closed with non-barbed suture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barbed PDS suture (STRATAFIX Symmetric PDS Plus) | Device | STRATAFIX Symmetric PDS Plus is a barbed suture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of incisional hernia | Incisional hernia till 1 year after surgery | from surgery to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time-event curve of incisional hernia | from surgery to 1 year | |
| Cumulative incidence of surgical site infection | from surgery to 4weeks | |
| Incidence of wound dehiscence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kidong Kim | Contact | 82 31 787 7262 | kidong.kim.md@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41259380 | Derived | Lee YJ, Kim NK, Kim K, Choi CH, Lee KH, Lee JM, Lee KB, Suh DH, Kim S, Kim MK, Seong SJ, Lim MC. Effect of fascial closure using barbed sutures on incisional hernias in midline laparotomy for gynecological diseases: A multicenter randomized controlled trial (KGOG 4001). PLoS One. 2025 Nov 19;20(11):e0337036. doi: 10.1371/journal.pone.0337036. eCollection 2025. | |
| 38901293 |
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2*2 factorial design Primary randomization: Barbed suture vs. Non-barbed suture in fascia closure Secondary randomization: subcutaneous drain insertion vs. non-insertion The effect of secondary randomization is one of secondary objectives.
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| Non-barbed PDS suture (PDS Plus) | Device | Non-barbed suture |
|
| post-surgery 4weeks |
| Brief Pain Inventory - Korean (BPI-K) score | Pain measured with BPI-K Specifically score (0-10 all domain, higher score mean worse outcome) in domain of worst pain, least pain, average pain, current pain, impact of pain in general activity, mood, work, relationship, ambulation, sleep and happiness | Baseline, postoperative day 2, 4 |
| Treatment related adverse event | from surgery to 1 year |
| NRS | pain captured by NRS in nursing record, 0-10, higher score means more pain | from surgery to postoperative 4 day |
| Choi CH, Kim NK, Kim K, Lee YJ, Lee KH, Lee JM, Lee KB, Suh DH, Kim S, Kim MK, Seong SJ, Lim MC. Effects of subcutaneous drain on wound dehiscence and infection in gynecological midline laparotomy: Secondary analysis of a Korean Gynecologic Oncology Group study (KGOG 4001). Eur J Surg Oncol. 2024 Sep;50(9):108484. doi: 10.1016/j.ejso.2024.108484. Epub 2024 Jun 12. |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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