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

Primary Purpose

Colorectal Surgery, Benign or Malignant Rectal or Colon Tumors

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation
Laparoscopic surgery under low pressure and conventional Insufflation
Sponsored by
Bordeaux Colorectal Institute Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Surgery focused on measuring colorectal pathology, laparoscopic, low pressure, early postoperative rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique TIVOLI DUCOS - Bordeaux Colorectal InstituteRecruiting
  • HOPITAL NORD APHM - Service de Chirurgie Digestive

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Pressure and warm and humidified CO2 insufflation

Low Pressure

Arm Description

Low pressure pneumoperitoneum and use warm and humidified CO2 insufflation

Low pressure pneumoperitoneum

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Operating time
Operating time
Conversion rate in normal pressure and laparotomy
Conversion rate in normal pressure (12-15mmHg) and laparotomy
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".
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"
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.
Rate of c-reactive protein
c-reactive protein levels in serum over 4 days post-surgery
Time to bowel opening and passage of gas
Time to bowel opening and passage of gas
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
Number of patients with R0 resection
Rate of cumulative surgery R0 resection for oncologic surgery
Length of stay in hospital
Length of stay in hospital
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
Number of patients taking analgesics until 30 days
To analyse the rate of analgesics using a patient subject diary
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".)
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)).
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.

Full Information

First Posted
May 30, 2023
Last Updated
September 1, 2023
Sponsor
Bordeaux Colorectal Institute Academy
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1. Study Identification

Unique Protocol Identification Number
NCT05934981
Brief Title
Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation
Acronym
PAROS3
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bordeaux Colorectal Institute Academy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Surgery, Benign or Malignant Rectal or Colon Tumors
Keywords
colorectal pathology, laparoscopic, low pressure, early postoperative rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Pressure and warm and humidified CO2 insufflation
Arm Type
Experimental
Arm Description
Low pressure pneumoperitoneum and use warm and humidified CO2 insufflation
Arm Title
Low Pressure
Arm Type
Active Comparator
Arm Description
Low pressure pneumoperitoneum
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation
Intervention Description
low pressure pneumoperitoneum (5-7mmHg) and use warm (35°C), humidified (95% relative humidity) CO2 insufflation.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic surgery under low pressure and conventional Insufflation
Intervention Description
low pressure pneumoperitoneum (5-7mmHg), and use standard room temperature with dry insufflation.
Primary Outcome Measure Information:
Title
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).
Description
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
Secondary Outcome Measure Information:
Title
Operating time
Description
Operating time
Time Frame
During surgery
Title
Conversion rate in normal pressure and laparotomy
Description
Conversion rate in normal pressure (12-15mmHg) and laparotomy
Time Frame
During surgery
Title
Peri-operative Heart Rate
Description
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
Title
Perioperative arterial blood pressure
Description
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
Title
Peri-operative temperature variations
Description
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
Title
Rate of c-reactive protein
Description
c-reactive protein levels in serum over 4 days post-surgery
Time Frame
from day 1 to day 4 after the end of surgery
Title
Time to bowel opening and passage of gas
Description
Time to bowel opening and passage of gas
Time Frame
An average of 3 days after the surgery
Title
Number of patients with medical and/or surgical morbidity
Description
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
Title
Number of patients with R0 resection
Description
Rate of cumulative surgery R0 resection for oncologic surgery
Time Frame
During Surgery
Title
Length of stay in hospital
Description
Length of stay in hospital
Time Frame
From the surgery to the end of the hospitalization (max30 days)
Title
Number of patients with pain at 30 days
Description
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
Title
Number of patients taking analgesics until 30 days
Description
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
Title
Mean Score of the EQ-5D-5L Quality of Life
Description
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
Title
Evaluation of predictive factors of postoperative pain
Description
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
Title
Evaluation of predictive factors of opioid intake
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quentin DENOST, Prof
Phone
+33 (0)5.47.50.15.75
Email
q.denost@bordeaux-colorectal-institute.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie GUILLON
Phone
+33 (0)5.47.50.15.75
Email
s.guillon@bordeaux-colorectal-institute.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quentin DENOST
Organizational Affiliation
Bordeaux Colorectal Institute Academy
Official's Role
Study Director
Facility Information:
Facility Name
Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quentin DENOST
Email
q.denost@bordeaux-colorectal-institute.fr
Facility Name
HOPITAL NORD APHM - Service de Chirurgie Digestive
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura BEYER-BERJOT
Email
laura.beyer@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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