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

Trial Title: Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation

NCT ID: NCT05934981

Condition: Colorectal Surgery
Benign or Malignant Rectal or Colon Tumors

Conditions: Official terms:
Colonic Neoplasms

Conditions: Keywords:
colorectal pathology
laparoscopic
low pressure
early postoperative rehabilitation

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation
Description: low pressure pneumoperitoneum (5-7mmHg) and use warm (35°C), humidified (95% relative humidity) CO2 insufflation.
Arm group label: Low Pressure and warm and humidified CO2 insufflation

Intervention type: Procedure
Intervention name: Laparoscopic surgery under low pressure and conventional Insufflation
Description: low pressure pneumoperitoneum (5-7mmHg), and use standard room temperature with dry insufflation.
Arm group label: Low Pressure

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute

Address:
City: Bordeaux
Country: France

Status: Recruiting

Contact:
Last name: Quentin DENOST
Email: q.denost@bordeaux-colorectal-institute.fr

Facility:
Name: HOPITAL NORD APHM - Service de Chirurgie Digestive

Address:
City: Marseille
Country: France

Status: Recruiting

Contact:
Last name: Laura BEYER-BERJOT
Email: laura.beyer@ap-hm.fr

Start date: August 30, 2023

Completion date: December 2025

Lead sponsor:
Agency: Bordeaux Colorectal Institute Academy
Agency class: Other

Source: Bordeaux Colorectal Institute Academy

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05934981