Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation (PAROS3)

• ClinicalTrials.gov Identifier: NCT05934981
• Recruitment Status: Recruiting
• First Posted: July 7, 2023
• Last Update Posted: March 13, 2024
• Sponsor: Bordeaux Colorectal Institute Academy
• Information provided by (Responsible Party): Bordeaux Colorectal Institute Academy

Tracking Information

• First Submitted Date: May 30, 2023
• First Posted Date: July 7, 2023
• Last Update Posted Date: March 13, 2024
• Actual Study Start Date: August 30, 2023
• Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 4, 2023)

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). [ Time Frame: At 24 hours after the end of surgery ]

Pain is evaluated with the Visual Analogue Scale (VAS, from 0 (no pain) to 10 (hurts worst)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 4, 2023)

• Operating time [ Time Frame: During surgery ]
  Operating time
• Conversion rate in normal pressure and laparotomy [ Time Frame: During surgery ]
  Conversion rate in normal pressure (12-15mmHg) and laparotomy
• Peri-operative Heart Rate [ Time Frame: During surgery ]
  Evaluation of Heart rate at different times during surgery : "after anesthetic intubation", "15 min after insufflation", and "5 min after exsufflation".
• Perioperative arterial blood pressure [ Time Frame: During surgery ]
  Evaluation of arterial pressure at different times during surgery : "after anesthetic intubation", "15 min after insufflation", and "5 min after exsufflation"
• Peri-operative temperature variations [ Time Frame: During surgery ]
  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.
• Rate of c-reactive protein [ Time Frame: from day 1 to day 4 after the end of surgery ]
  c-reactive protein levels in serum over 4 days post-surgery
• Time to bowel opening and passage of gas [ Time Frame: An average of 3 days after the surgery ]
  Time to bowel opening and passage of gas
• Number of patients with medical and/or surgical morbidity [ Time Frame: From the end of surgery until 3 months of follow-up ]
  To analyse the cumulative morbidity at 30 days after surgery and at 3 months of follow-up according to the Clavien-DINDO classification
• Number of patients with R0 resection [ Time Frame: During Surgery ]
  Rate of cumulative surgery R0 resection for oncologic surgery
• Length of stay in hospital [ Time Frame: From the surgery to the end of the hospitalization (max30 days) ]
  Length of stay in hospital
• Number of patients with pain at 30 days [ Time Frame: From the end of the surgery until 30 days of follow-up ]
  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
• Number of patients taking analgesics until 30 days [ Time Frame: From the end of the surgery until 30 days of follow up ]
  To analyse the rate of analgesics using a patient subject diary
• Mean Score of the EQ-5D-5L Quality of Life [ Time Frame: From randomization until 3 months after surgery ]
  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".)
• Evaluation of predictive factors of postoperative pain [ Time Frame: From the surgery until 30 days of follow up ]
  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)).
• Evaluation of predictive factors of opioid intake [ Time Frame: From the surgery until 30 days of follow up ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Colorectal Surgery
• Benign or Malignant Rectal or Colon Tumors

Intervention

• Procedure: Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation
  low pressure pneumoperitoneum (5-7mmHg) and use warm (35°C), humidified (95% relative humidity) CO2 insufflation.
• Procedure: Laparoscopic surgery under low pressure and conventional Insufflation
  low pressure pneumoperitoneum (5-7mmHg), and use standard room temperature with dry insufflation.

Study Arms

• Experimental: Low Pressure and warm and humidified CO2 insufflation
  Low pressure pneumoperitoneum and use warm and humidified CO2 insufflation
  Intervention: Procedure: Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation
• Active Comparator: Low Pressure
  Low pressure pneumoperitoneum
  Intervention: Procedure: Laparoscopic surgery under low pressure and conventional Insufflation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 4, 2023): 148
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Quentin DENOST, Prof; +33 (0)5.47.50.15.75; q.denost@bordeaux-colorectal-institute.fr

Contact: Stéphanie GUILLON; +33 (0)5.47.50.15.75; s.guillon@bordeaux-colorectal-institute.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT05934981
• Other Study ID Numbers: BCIA 2022/01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Bordeaux Colorectal Institute Academy
• Original Responsible Party: Same as current
• Current Study Sponsor: Bordeaux Colorectal Institute Academy
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Quentin DENOST; Bordeaux Colorectal Institute Academy

• PRS Account: Bordeaux Colorectal Institute Academy
• Verification Date: July 2023