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

Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection With Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Surgery; Benign or Malignant Rectal or Colon Tumors
• Intervention / Treatment: Procedure: Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation; Procedure: Laparoscopic surgery under low pressure and conventional Insufflation

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
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quentin DENOST, Prof; Phone Number: +33 (0)5.47.50.15.75; Email: q.denost@bordeaux-colorectal-institute.fr
• Study Contact Backup: Name: Stéphanie GUILLON; Phone Number: +33 (0)5.47.50.15.75; Email: s.guillon@bordeaux-colorectal-institute.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute
    • Contact: Quentin DENOST; Email: q.denost@bordeaux-colorectal-institute.fr
  • Marseille, France
    • Recruiting
    • HOPITAL NORD APHM - Service de Chirurgie Digestive
    • Contact: Laura BEYER-BERJOT; Email: laura.beyer@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Pressure and warm and humidified CO2 insufflation; Low pressure pneumoperitoneum and use warm and humidified CO2 insufflation	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.
Active Comparator: Low Pressure; Low pressure pneumoperitoneum	Procedure: Laparoscopic surgery under low pressure and conventional Insufflation; low pressure pneumoperitoneum (5-7mmHg), and use standard room temperature with dry insufflation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Pain is evaluated with the Visual Analogue Scale (VAS, from 0 (no pain) to 10 (hurts worst)	At 24 hours after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From the end of surgery until 3 months of follow-up
Number of patients taking analgesics until 30 days	To analyse the rate of analgesics using a patient subject diary	From the end of the surgery until 30 days of follow up
Operating time	Operating time	During surgery
Conversion rate in normal pressure and laparotomy	Conversion rate in normal pressure (12-15mmHg) and laparotomy	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".	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"	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.	During surgery
Rate of c-reactive protein	c-reactive protein levels in serum over 4 days post-surgery	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	An average of 3 days after the surgery
Number of patients with R0 resection	Rate of cumulative surgery R0 resection for oncologic surgery	During Surgery
Length of stay in hospital	Length of stay in hospital	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	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".)	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)).	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.	From the surgery until 30 days of follow up

Collaborators and Investigators

• Sponsor: Bordeaux Colorectal Institute Academy
• Investigators: Study Director: Quentin DENOST, Bordeaux Colorectal Institute Academy

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: laparoscopic; colorectal pathology; low pressure; early postoperative rehabilitation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: BCIA 2022/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No