Laparoscopic Colorectal Surgery Using Low-pressure Combined with Warm and Humidified Carbon Dioxide Insufflation

Launched by BORDEAUX COLORECTAL INSTITUTE ACADEMY · Jul 4, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to laparoscopic colorectal surgery, which is a minimally invasive surgery to treat tumors in the colon or rectum. The focus of the study is on using low-pressure carbon dioxide that is warm and humidified instead of cold and dry gas during the procedure. The goal is to see if this method can help reduce post-operative pain after surgery, making recovery easier for patients.

To participate in this trial, individuals must be at least 18 years old and undergoing colorectal surgery for either benign or malignant conditions, but certain criteria apply. For example, patients who need a stoma (an opening created for waste removal) or have specific health issues like Crohn's disease cannot join. If eligible, participants will be randomly assigned to receive either the warm gas method or the traditional cold gas method during their surgery. Throughout the study, patients will be monitored to assess their pain levels and overall recovery without using opioid pain medications. This trial aims to improve patient comfort and outcomes following surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Colorectal surgery for malignant or benign pathology
• • Surgery without stoma
• • Patient operable by laparoscopy or robot assisted under low pressure pneumoperitoneum
• • Age ≥ 18 years old
• • Patient affiliated to a social security system or beneficiary of the same
• • Informing the patient and obtaining free, informed, and written consent, signed by the patient and his investigator.
• Exclusion Criteria:
• • Laparotomy procedure
• • Total or Subtotal Colectomy
• • Transverse segmental colectomy
• • Proctectomy with stoma or Total Coloproctectomy
• • Procedure associated with colorectal surgery (except appendectomy or liver biopsy)
• • Patient with stoma
• • Probable realization of a stoma during the operation
• • Crohn's disease, Hemorrhagic Rectocolitis (UC)
• • Sigmoiditis
• • VAS before surgery\> 3
• • BMI ≥ 30
• • ASA ≥ 3
• • History of laparotomy
• • Emergency surgery
• • Pelvic Sepsis or Preoperative Fistula
• • Pregnant woman, likely to be, or breastfeeding
• • Persons deprived of their liberty or under measure of judicial protection (curators or guardianship) or unable to give their consent
• • Persons undergoing psychiatric treatment without their consent
• • Persons admitted to a health or social establishment for purposes other than research
• • Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons