Clinical trial NCT05934981: Laparoscopic Colorectal Surgery Using Low-pressure Combined with Warm and Humidified Carbon Dioxide Insufflation
Official title: Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection with Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Surgery
Benign or Malignant Rectal or Colon Tumors
Keywords: colorectal pathology
laparoscopic
low pressure
early postoperative rehabilitation
Lead sponsor: Bordeaux Colorectal Institute Academy
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Laparoscopy is the gold standard in colorectal surgery with many benefits in term of morbidity, post-operative pain and analgesic consumption. However, the pneumoperitoneum created for the laparoscopy has several negatives impact and limits (specific pain following abdominal distension, visibility, physiological repercussion).

To improve recovery after colorectal laparoscopic surgery it was realized a first study (PAROS 1) which showed that low-pressure laparoscopic colectomy for benign or malign disease was feasible and safe with shorter length of stay (3 vs. 4 days; p=0.001), and decrease post-operative pain (VAS ≤ 3 à H8: 87% vs. 72% ; p=0.039) with reduction of analgesic consumption (step II analgesics: 73% vs. 88% ; p=0.032 and step 3 analgesics: (10% vs.23% ; p=0.042) (Br J Surg. 2021 Aug 19;108(8):998-1005) Simultaneously, the development of humidification medical device, referring to the administration of heated and humidified CO2 during laparoscopic surgery, aims to reduce the effects of cell drying and evaporative heat loss when the body is exposed to cold CO2. and dry during laparoscopic surgery. The state of the CO2 traditionally used during laparoscopic surgery and the ambient air during open surgery is very different from that of the human body, as it directly extracts heat and humidity from the already fragile patient.

The introduction of heated and humidified CO2 provides an environment that reflects the physiological state of the peritoneum.

Added to the benefits of low pressure, the advantages of surgical humidification seem very positive. During surgery, surgical humidification would reduce the incidence of perioperative hypothermia, improve local tissue oxygenation and local tissue perfusion. After surgery, it would improve core body temperature, reduce local peritoneal inflammation, surgical site infection rate and recovery time. The benefits of a warmed and humidified CO2 also seem very positive in terms of reducing postoperative pain and analgesic consumption. In the long term, it would reduce adhesion formation, tumor burden, metastases, and economic cost.

The aim of the study is to assess the impact of low-pressure pneumoperitoneum with warm and humidified CO2 insufflation on post-operative pain without taking opioids, compared with low-pressure laparoscopy with cold and dry gas insufflation.

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

Primary outcomes:
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).
timeFrame: At 24 hours after the end of surgery
Secondary outcomes:
measure: Operating time
timeFrame: During surgery
measure: Conversion rate in normal pressure and laparotomy
timeFrame: During surgery
measure: Peri-operative Heart Rate
timeFrame: During surgery
measure: Perioperative arterial blood pressure
timeFrame: During surgery
measure: Peri-operative temperature variations
timeFrame: During surgery
measure: Rate of c-reactive protein
timeFrame: from day 1 to day 4 after the end of surgery
measure: Time to bowel opening and passage of gas
timeFrame: An average of 3 days after the surgery
measure: Number of patients with medical and/or surgical morbidity
timeFrame: From the end of surgery until 3 months of follow-up
measure: Number of patients with R0 resection
timeFrame: During Surgery
measure: Length of stay in hospital
timeFrame: From the surgery to the end of the hospitalization (max30 days)
measure: Number of patients with pain at 30 days
timeFrame: From the end of the surgery until 30 days of follow-up
measure: Number of patients taking analgesics until 30 days
timeFrame: From the end of the surgery until 30 days of follow up
measure: Mean Score of the EQ-5D-5L Quality of Life
timeFrame: From randomization until 3 months after surgery
measure: Evaluation of predictive factors of postoperative pain
timeFrame: From the surgery until 30 days of follow up
measure: Evaluation of predictive factors of opioid intake
timeFrame: From the surgery until 30 days of follow up
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute
city: Marseille
country: France
facility: HOPITAL NORD APHM - Service de Chirurgie Digestive
Study officials:
affiliation: Bordeaux Colorectal Institute Academy
name: Quentin DENOST
role: STUDY_DIRECTOR
References: