NCT04742881 Low Impact Laparoscopic in Colorectal Resection - PAROS2
| NCT ID | NCT04742881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Malignant or Benign Pathology |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2022-12-14 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 148 participants in total. It began in 2022-12-14 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Christophe LAURENT
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT04742881 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant or Benign Pathology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04742881 currently recruiting?
Yes, NCT04742881 is actively recruiting participants. Contact the research team at christophe.laurent@chu-bordeaux.fr for enrollment information.
Where is the NCT04742881 trial being conducted?
This trial is being conducted at Bayonne, France, Bordeaux, France, Libourne, France.
Who is sponsoring the NCT04742881 clinical trial?
NCT04742881 is sponsored by University Hospital, Bordeaux. The principal investigator is Christophe LAURENT at University Hospital, Bordeaux. The trial plans to enroll 148 participants.