Low Impact Laparoscopic in Colorectal Resection - PAROS2
PAROS2
1 other identifier
interventional
148
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2021
CompletedStudy Start
First participant enrolled
December 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
May 22, 2025
May 1, 2025
3.5 years
January 22, 2021
May 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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 Outcomes (13)
Operating time
During surgery
Conversion rate in normal pressure laparoscopy and or in laparotomy
During surgery
Intraoperative analgesia nociception index (ANI)
During surgery
Peri-operative cardiovascular and respiratory components
During surgery
Time to resume transit and gas
An average of 5 days after the surgery
- +8 more secondary outcomes
Study Arms (2)
Low pressure + microsurgical instruments
EXPERIMENTALLow pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
Low pressure + standard instruments
ACTIVE COMPARATORLow pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)
Interventions
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CH de la Côte Basque
Bayonne, France
CHU Bordeaux
Bordeaux, France
Ch Libourne
Libourne, France
Related Publications (1)
Marichez A, Eude A, Martenot M, Celerier B, Capdepont M, Rullier E, Denost Q, Fernandez B. Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial. Colorectal Dis. 2023 Dec;25(12):2403-2413. doi: 10.1111/codi.16787. Epub 2023 Oct 27.
PMID: 37897108DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe LAURENT
University Hospital, Bordeaux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2021
First Posted
February 8, 2021
Study Start
December 14, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
May 22, 2025
Record last verified: 2025-05