Laparoscopic colorectal surgery with warm and humidified CO2
Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection With Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone
This study is testing if using warm and humidified carbon dioxide during laparoscopic colorectal surgery can help patients recover with less pain and fewer pain medications compared to the usual cold and dry method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bordeaux Colorectal Institute Academy Academic / other |
| Locations | 2 sites (Bordeaux and 1 other locations) |
| Trial ID | NCT05934981 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance post-operative recovery for patients undergoing laparoscopic colorectal surgery by utilizing a medical device that combines low-pressure pneumoperitoneum with heated and humidified carbon dioxide insufflation. The study is designed as a double-blind, prospective, randomized, controlled trial to compare the effects of this innovative approach against traditional cold and dry insufflation. The primary focus is to assess post-operative pain levels at 24 hours without opioid use, with the goal of improving patient outcomes and reducing analgesic consumption. Previous studies have indicated that low-pressure laparoscopic techniques can lead to shorter hospital stays and decreased pain.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for laparoscopic colorectal surgery for benign or malignant conditions without the need for a stoma.
Not a fit: Patients who may not benefit from this study include those requiring laparotomy procedures, those with a history of severe obesity or significant comorbidities, and individuals with certain gastrointestinal diseases.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and improve recovery times for patients undergoing colorectal surgery.
How similar studies have performed: Previous studies have shown promising results with low-pressure laparoscopic techniques, indicating that this approach may build on established findings.
Eligibility criteria
Show full inclusion / exclusion 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) with VAS \> 3 * Diverticulitis or Sigmoiditis with VAS \> 3 * Endometriosis with VAS \>3 * VAS before surgery\> 3 * BMI ≥ 30 * ASA ≥ 3 (except if ASA 3 for non-cardiac and/or vascular diseases) * 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
Where this trial is running
Bordeaux and 1 other locations
- Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute — Bordeaux, France (Recruiting)
- HOPITAL NORD APHM - Service de Chirurgie Digestive — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Quentin DENOST, Prof
- Email: q.denost@bordeaux-colorectal-institute.fr
- Phone: +33 (0)5.47.50.15.75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.