Clinical trial · Interventional
Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation
Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection With Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To improve post-operative recovery, medical device was developed combining low-pressure pneumoperitoneum and heated and humidified Carbon Dioxide (95˚F \& 95% RH) during laparoscopic surgery to reduce the harmful effects of cold/dry insufflation. A double-blind, prospective, randomized, controlled, monocentric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with warm and humidified gaz on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with cold and dry gaz in patients undergoing colorectal surgeries.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign or Malignant Rectal or Colon Tumors | Colon Neoplasm | PROBABILISTIC | 0.70 |
| Colorectal Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgery under low pressure and conventional Insufflation | Procedure | — | UNRESOLVED |
| Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low Pressure and warm and humidified CO2 insufflation
- description
- Low pressure pneumoperitoneum and use warm and humidified CO2 insufflation
- interventionNames
- Procedure: Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation
- type
- ACTIVE_COMPARATOR
- label
- Low Pressure
- description
- Low pressure pneumoperitoneum
- interventionNames
- Procedure: Laparoscopic surgery under low pressure and conventional Insufflation
Primary outcomes (1)
- measure
- Number of patients with pain at 24 hours after the end of the intervention by VAS ≤ 3 without taking opioids (without step 2 and step 3 analgesics).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHe J, Pan X. Carbon dioxide laparoscopic technology: research hotspots and innovations in pneumoperitoneum detection. Med Gas Res. 2026 Dec 1;16(4):415-425. doi: 10.4103/mgr.MEDGASRES-D-25-00206. Epub 2026 Mar 26. PMID 41888042