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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
148
low pressure pneumoperitoneum (5-8mmHg) and use warm (35°C), humidified (95% relative humidity) CO2 insufflation.
low pressure pneumoperitoneum (5-8mmHg), and use standard room temperature with dry insufflation.
Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute
Bordeaux, France
RECRUITINGHOPITAL NORD APHM - Service de Chirurgie Digestive
Marseille, France
RECRUITINGNumber 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).
Pain is evaluated with the Visual Analogue Scale (VAS, from 0 (no pain) to 10 (hurts worst)
Time frame: At 24 hours after the end of surgery
Operating time
Operating time
Time frame: During surgery
Conversion rate in normal pressure and laparotomy
Conversion rate in normal pressure (12-15mmHg) and laparotomy
Time frame: During surgery
Peri-operative Heart Rate
Evaluation of Heart rate at different times during surgery : "after anesthetic intubation", "15 min after insufflation", and "5 min after exsufflation".
Time frame: During surgery
Perioperative arterial blood pressure
Evaluation of arterial pressure at different times during surgery : "after anesthetic intubation", "15 min after insufflation", and "5 min after exsufflation"
Time frame: During surgery
Peri-operative temperature variations
Evaluation of ambient theatre temperature and body temperature at different times during surgery : "before incision", "15 min after insufflation",then every hour and the last temperature reading at the end of the surgery.
Time frame: During surgery
Rate of c-reactive protein
c-reactive protein levels in serum over 4 days post-surgery
Time frame: from day 1 to day 4 after the end of surgery
Time to bowel opening and passage of gas
Time to bowel opening and passage of gas
Time frame: An average of 3 days after the surgery
Number of patients with medical and/or surgical morbidity
To analyse the cumulative morbidity at 30 days after surgery and at 3 months of follow-up according to the Clavien-DINDO classification
Time frame: From the end of surgery until 3 months of follow-up
Number of patients with R0 resection
Rate of cumulative surgery R0 resection for oncologic surgery
Time frame: During Surgery
Length of stay in hospital
Length of stay in hospital
Time frame: From the surgery to the end of the hospitalization (max30 days)
Number of patients with pain at 30 days
Pain was evaluated with the Visual Analogue Scale (VAS, from 0 (no pain) to 10 (hurts worst)) during hospital stay and until 30 days using a patient subject diary every day and immediately before each use of pain medication
Time frame: From the end of the surgery until 30 days of follow-up
Number of patients taking analgesics until 30 days
To analyse the rate of analgesics using a patient subject diary
Time frame: From the end of the surgery until 30 days of follow up
Mean Score of the EQ-5D-5L Quality of Life
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The questionnaire is a self-report survey that measures quality of life across 5 domains: : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state \- The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, numbered from 0 to 100. ( 100 means "the best health you can imagine" and 0 means "the worst health you can imagine".)
Time frame: From randomization until 3 months after surgery
Evaluation of predictive factors of postoperative pain
Study the predictive factors of postoperative pain (VAS\>3), 24 hours and 30 days after the surgery. (Visual Analogue Scale (VAS), from 0 (no pain) to 10 (hurts worst)).
Time frame: From the surgery until 30 days of follow up
Evaluation of predictive factors of opioid intake
To identify predictive factors of opioid intake (second step and/or third step of the Who analgesic ladder),24 hours and 30 days after the surgery. Comparison of the clinical and perioperative data from patients who did or did not consume opioids after surgery. The differences in proportions will be compared.
Time frame: From the surgery until 30 days of follow up
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