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Low Impact Laparoscopic in Colorectal Resection - PAROS2 (PAROS2)

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ClinicalTrials.gov Identifier: NCT04742881
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE January 22, 2021
First Posted Date  ICMJE February 8, 2021
Last Update Posted Date April 24, 2024
Actual Study Start Date  ICMJE December 14, 2022
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2021)		 Number of patients with pain at 24 hours after the end of the intervention by NRS ≤ 3 without taking opioids (without pain reliever 2 and 3) [ Time Frame: At 24 hours after the end of surgery ]
Pain is evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2022)
  • Operating time [ Time Frame: During surgery ]
  • Conversion rate in normal pressure laparoscopy and or in laparotomy [ Time Frame: During surgery ]
  • Intraoperative analgesia nociception index (ANI) [ Time Frame: During surgery ]
  • Peri-operative cardiovascular and respiratory components [ Time Frame: During surgery ]
  • Time to resume transit and gas [ Time Frame: An average of 5 days after the surgery ]
  • 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 curative surgery R0 resection for oncologic surgery
  • Number of lymph nodes examined [ Time Frame: During surgery ]
    Number of lymph nodes examined by the pathologist for oncologic surgery
  • Length of stay in hospital [ Time Frame: From surgery to the end of the hospitalization (max 30 days) ]
  • 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 Numeric Rating Scale 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
  • Impact of microsurgical instruments on the aesthetic appearance [ Time Frame: 30 days after surgery and 3 months of follow up ]
    Rate of scar satisfaction at 30days and at 3 months after surgery
  • Mean score of the EQ-5D-5L Quality of life [ Time Frame: From randomization until 3 months of follow up ]
    Health related quality of life will be assessed using the Short Form EQ-5D-5L Health Survey questionnaire. The EQ-5D-5L is a generic health status measurement instrument. It is made up of 5 questions and a visual scale. A question for each of the following aspects: mobility, the ability to wash and dress, daily activities, discomfort and pain, anxiety as well as a score for the patient's perception of the quality of life. The questionnaire is administered the day before the surgery and 1 month and 3 months after the surgery.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2021)
  • Operating time [ Time Frame: During surgery ]
  • Conversion rate in normal pressure laparoscopy and or in laparotomy [ Time Frame: During surgery ]
  • Time to resume transit and gas [ Time Frame: An average of 5 days after the surgery ]
  • 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 curative surgery R0 resection for oncologic surgery
  • Number of lymph nodes examined [ Time Frame: During surgery ]
    Number of lymph nodes examined by the pathologist for oncologic surgery
  • Length of stay in hospital [ Time Frame: From surgery to the end of the hospitalization (max 30 days) ]
  • 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 Numeric Rating Scale 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
  • Impact of microsurgical instruments on the aesthetic appearance [ Time Frame: 30 days after surgery and 3 months of follow up ]
    Rate of scar satisfaction at 30days and at 3 months after surgery
  • Mean score of the SF36 Quality of life [ Time Frame: From randomization until 3 months of follow up ]
    Health related quality of life will be assessed using the Short Form 36 Health Survey questionnaire. The SF-36 is a generic health status measurement instrument. It can be used to assess health status independent of which diseases or illnesses affect the population under study. It is made up of 36 questions divided into 8 scales ( Score from 0 to 10). The questionnaire was administered the day before the surgery and 1 month and 3 months after the surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Impact Laparoscopic in Colorectal Resection - PAROS2
Official Title  ICMJE Low Impact Laparoscopic in Colorectal Resection: a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone
Brief Summary To improve post-operative recovery, the concept of Low Impact Laparoscopy was developed in colo-rectal surgery with associating low-pressure pneumoperitoneum and microlaparoscopic surgery. A phase III double-blind, prospective, randomized, controlled, multi-centric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with classical laparoscopic instruments 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) which showed that low-pressure laparoscopic colectomy for benign or malign disease was feasible and safe with shorter length of stay and decrease post-operative pain with reduction of analgesic consumption.

Minimally invasive technics like microlaparoscopic surgery, developed last years had also an impact by decreasing post operative pain. The Low Impact Laparoscopy concept was developed in colo-rectal surgery with the association of low-pressure pneumoperitoneum and microlaparoscopic surgery.

The aim of the study is to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain without taking opioids, compared with low-pressure laparoscopy with classical laparoscopic instruments in patients undergoing colorectal surgeries.

The design of this study is a phase III double-blind, prospective, randomized, controlled, multi-centric trial. The primary endpoint is the rate of patients with postoperative pain defined 24h after the end of the intervention by visual analog scale (VAS) ≤ 3 without taking opioids (analgesics level II or III). Secondary outcomes are operating time, conversion rate in normal pressure laparoscopy or in laparotomy, morbidity at 3 months, quality of oncological surgery, length of stay, impact of microlaparoscopic instruments of aesthetic appearance at 3 months.

The primary end point will be assessed at 24h after the end of the surgery by a blind nurse evaluating the pain intensity. After discharge of the hospital, patients will be followed with postoperative consultation at 1 month and 3 month.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Malignant or Benign Pathology
Intervention  ICMJE
  • Procedure: Low pressure + microsurgical instruments
    Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
  • Procedure: Low pressure + standard instruments
    Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)
Study Arms  ICMJE
  • Experimental: Low pressure + microsurgical instruments
    Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
    Intervention: Procedure: Low pressure + microsurgical instruments
  • Active Comparator: Low pressure + standard instruments
    Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)
    Intervention: Procedure: Low pressure + standard instruments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2021)		 148
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2025
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Scheduled colectomy for malignant or benign pathology
  • Right colon: ileocecal resection, right colectomy, right colectomy extended to the middle of the transverse
  • Left colon: sigmoidectomy, left colectomy
  • Rectal resection without stoma for cancer of the upper rectum
  • Patient operable by laparoscopy (classic or robot assisted for the Standard group)
  • 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
  • Patients with electronic implant (ex : pacemaker)
  • Total or Subtotal Colectomy
  • Transverse segmental colectomy
  • Left angular colectomy
  • Proctectomy with stoma or Total Coloproctectomy
  • Patient with stoma
  • Probable realization of a stoma during the operation
  • Procedure associated with colorectal surgery (except appendectomy or liver biopsy)
  • Crohn's disease, Hemorrhagic Rectocolitis (UC)
  • Sigmoiditis
  • EVA 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 (curatorship or guardianship) or unable to give their consent
  • Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christophe LAURENT +33 (0)5 56 79 58 10 christophe.laurent@chu-bordeaux.fr
Contact: Benjamin FERNANDEZ +33 (0)5 56 79 58 10 benjamin.fernandez@chu-bordeaux.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04742881
Other Study ID Numbers  ICMJE CHUBX 2020/30
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  ICMJE Not Provided
Current Responsible Party University Hospital, Bordeaux
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Bordeaux
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christophe LAURENT University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP