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โ† Trials
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Low Impact Laparoscopic in Colorectal Resection - PAROS2

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Bordeaux
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ 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
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What it tests

  • Low pressure + microsurgical instruments
  • Low pressure + standard instruments
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Where

3 sites
CH de la Cรดte Basque
Bayonne, France
CHU Bordeaux
Bordeaux, France
Ch Libourne
Libourne, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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