Status:
RECRUITING
Low Impact Laparoscopic in Colorectal Resection - PAROS2
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Malignant or Benign Pathology
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Laparoscopy is the gold standard in colorectal surgery with many benefits in term of morbidity, post-operative pain and analgesic consumption. However the pneumoperitoneum created for the laparoscopy ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04742881
Start Date
December 14 2022
End Date
September 1 2026
Last Update
May 22 2025
Active Locations (3)
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1
CH de la Côte Basque
Bayonne, France
2
CHU Bordeaux
Bordeaux, France
3
Ch Libourne
Libourne, France