An interventional study of Monofix in Colon Cancer, Rectal Cancer and Colon Adenocarcinoma, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Prevention
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 120 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Monofix
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.
a new absorbable barbed suture device
Incisional hernia
Incisional hernia diagnosed by CT scan.
Time frame: 18 months from surgery
Wound infection
In cases where microorganisms were identified in the wound culture results.
Time frame: 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.
Time frame: 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.
Time frame: 1 month from surgery
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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