Low Impact Laparoscopic in Colorectal Resection: a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH de la Côte Basque
RECRUITING
Bayonne
CHU Bordeaux
RECRUITING
Bordeaux
Ch Libourne
RECRUITING
Libourne
Contact Information
Primary
Christophe LAURENT
christophe.laurent@chu-bordeaux.fr
+33 (0)5 56 79 58 10
Backup
Benjamin FERNANDEZ
benjamin.fernandez@chu-bordeaux.fr
+33 (0)5 56 79 58 10
Time Frame
Start Date: 2022-12-14
Estimated Completion Date: 2026-09
Participants
Target number of participants: 148
Treatments
Experimental: Low pressure + microsurgical instruments
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
Active_comparator: Low pressure + standard instruments
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov

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