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Low Impact Laparoscopic in Colorectal Resection - PAROS2

NCT04742881 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

  • Malignant or Benign Pathology

Interventions

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)

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Christophe LAURENT · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2026-06-30
Completion
2026-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742881 on ClinicalTrials.gov