Low Impact Laparoscopic in Colorectal Resection - PAROS2
Low Impact Laparoscopic in Colorectal Resection: a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone
University Hospital, Bordeaux
148 participants
Dec 14, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria20
- 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
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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)
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT04742881