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Recruiting NCT04742881

Low Impact Laparoscopic in Colorectal Resection - PAROS2

Trial Parameters

Condition Malignant or Benign Pathology
Sponsor University Hospital, Bordeaux
Study Type INTERVENTIONAL
Phase N/A
Enrollment 148
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-12-14
Completion 2026-06
Interventions
Low pressure + microsurgical instrumentsLow pressure + standard instruments

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.

Eligibility Criteria

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 dis

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