A study on the usefulness of preoperative stoma site marking with eyeliner

UMIN ID: UMIN000054608

Registered date:10/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients undergoing surgery including intestinal stoma construction
• Date of first enrollment: 2024/06/10
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Following the Cleveland Clinic stoma site marking method, surgeons and nurses mark the stoma site on the patient's abdomen at the stoma construction site using a water-based pen and an oil-based pen, one on each side of the abdomen. For emergency surgery cases, stoma site marking is performed immediately before surgery. For stoma site marking, a photograph of the abdomen is taken with a digital camera and the stoma site marking site is recorded. On the morning of the day of surgery, a 3cm circular stoma site marking is performed at the site where stoma site marking was performed the previous day with an oil-based pen. In the operating room, after general anesthesia is induced, another doctor who has not performed stoma site marking disinfects the abdomen with povidone iodine. The patient is covered with a drape and the surgeon evaluates whether the stoma site markings on the left and right abdomen can be confirmed just before operating. Just before constructing a stoma, the surgeon evaluates again whether the stoma site markings can be confirmed. In order to maintain objectivity, the evaluation of stoma site marking is scored using a point system. The following definitions apply: 2 points for fully confirmed stoma site marking, 1 point for barely confirmed stoma site marking, and 0 point for difficult to confirm stoma site marking.
Following the Cleveland Clinic stoma site marking method, surgeons and nurses mark the stoma site on the patient's abdomen at the stoma construction site using a water-based pen and an oil-based pen, one on each side of the abdomen. For emergency surgery cases, stoma site marking is performed immediately before surgery. For stoma site marking, a photograph of the abdomen is taken with a digital camera and the stoma site marking site is recorded. On the morning of the day of surgery, a 3cm circular stoma site marking is performed at the site where stoma site marking was performed the previous day with an eyeliner. In the operating room, after general anesthesia is induced, another doctor who has not performed stoma site marking disinfects the abdomen with povidone iodine. The patient is covered with a drape and the surgeon evaluates whether the stoma site markings on the left and right abdomen can be confirmed just before operating. Just before constructing a stoma, the surgeon evaluates again whether the stoma site markings can be confirmed. In order to maintain objectivity, the evaluation of stoma site marking is scored using a point system. The following definitions apply: 2 points for fully confirmed stoma site marking, 1 point for barely confirmed stoma site marking, and 0 point for difficult to confirm stoma site marking.

Outcome(s)

• Primary Outcome: Percentage of stoma site markings confirmed by surgeons during stoma construction
• Secondary Outcome: allergic complication rate postoperative infection rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Cases with active bleeding such as abdominal stab wounds and cases with a history of multiple laparotomies in which it is difficult to perform two stoma site markings

Related Information

• Primary Sponsor: Department of Surgery, Teikyo University Chiba Medical Center
• Source(s) of Monetary Support: None