Low Impact Laparoscopic in Colorectal Resection - PAROS2 (PAROS2)

May 21, 2025 updated by: University Hospital, Bordeaux

Low Impact Laparoscopic in Colorectal Resection: a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low pressure + microsurgical instruments
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
Procedure: Low pressure + microsurgical instruments
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
Active Comparator: Low pressure + standard instruments
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)
Procedure: Low pressure + standard instruments
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)

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 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)
At 24 hours after the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time
Time Frame: During surgery
During surgery
Conversion rate in normal pressure laparoscopy and or in laparotomy
Time Frame: During surgery
During surgery
Intraoperative analgesia nociception index (ANI)
Time Frame: During surgery
During surgery
Peri-operative cardiovascular and respiratory components
Time Frame: During surgery
During surgery
Time to resume transit and gas
Time Frame: An average of 5 days after the surgery
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
From the end of surgery until 3 months of follow-up
Number of patients with R0 resection
Time Frame: During surgery
Rate of curative surgery R0 resection for oncologic surgery
During surgery
Number of lymph nodes examined
Time Frame: During surgery
Number of lymph nodes examined by the pathologist for oncologic surgery
During surgery
Length of stay in hospital
Time Frame: From surgery to the end of the hospitalization (max 30 days)
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
From the end of the surgery until 30 days of follow up
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
From the end of the surgery until 30 days of follow up
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
30 days after surgery and 3 months of follow up
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.
From randomization until 3 months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Christophe LAURENT, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHUBX 2020/30

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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