Short term outcomes of Randomized Controlled Trial of Senhance Digital Laparoscopy System versus Laparoscopic colectomy for colon cancer

UMIN ID: UMIN000053839

Registered date:16/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: colon cancer
• Date of first enrollment: 2024/04/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Senhance digital laparoscopy system
Laparoscopic surgery

Outcome(s)

• Primary Outcome: Postoperative complications
• Secondary Outcome: Operarive times, blood loss, intraoperative complications, conversion rate, postoperative stays, pathlogical findings

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Multiple cancers Active infectious disease Previous psychiatric and/or central nervous system disorders Pregnancy, lactation, or possible pregnancy Serious concomitant illness (cardiopulmonary dysfunction, renal failure, intestinal paralysis, intestinal obstruction, uncontrolled disease, etc.) (intestinal paralysis, intestinal obstruction, uncontrolled diabetes, renal failure, cirrhosis, chronic hepatitis B, chronic hepatitis C, etc.) No history of organ transplantation Receiving preoperative treatment for colorectal cancer (chemotherapy, radiation therapy, hormonal therapy, etc.) Patients deemed unsuitable for study enrollment by the investigator

Related Information

• Primary Sponsor: Saitama medical university international medical center
• Source(s) of Monetary Support: Saitama medical university international medical center