Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.

Launched by FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL CLÍNICO DE VALENCIA · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well a new powered circular stapler works compared to traditional manual staplers in patients undergoing a specific type of surgery called colorectal anastomosis. This surgery is performed after procedures like left colectomy, sigmoidectomy, or anterior rectal resection, which are done to treat conditions affecting the colon or rectum. The trial is looking for adults who are at least 18 years old and can provide informed consent. However, patients who have certain conditions, such as needing emergency surgery or having a high American Society of Anesthesiologists (ASA) score, cannot participate.

If you or a loved one joins the trial, you will be randomly assigned to one of two groups: one that will use the new powered stapler and another that will use the manual stapler. The study will follow participants for 30 days after surgery to see how well each stapler works in helping the surgical site heal. This research aims to improve surgical outcomes and may help guide future practices in colorectal surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient or its legal representative informed consent.
• • Age ≥ 18 years.
• • Patients who will undergo a colorectal anastomosis after left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology (NOTE: Hartmann reversal cases also included).
• Exclusion Criteria:
• • Diverting stoma.
• • Emergency surgery.
• • American Society of Anaesthesiologists (ASA) score ≥ IV.
• • Transanal total mesorectal excision approach.