Status:
COMPLETED
Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Colonic Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this press...
Eligibility Criteria
Inclusion
- Colic lesion justifying surgical resection by segmental colectomy,
- Surgery proposed by laparoscopy,
- Body mass index (BMI) ≤30 kg/m2,
- Written informed consent signed by the patient,
- Patient affiliated to the national French statutory healthcare insurance, system or beneficiary of this regimen.
Exclusion
- Probable realization of a stoma during the procedure,
- Robot-assisted approach,
- Contraindication to laparoscopic surgery,
- Pregnant or likely to be pregnant,
- Patient deprived of liberty or placed under the authority of a tutor,
- Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2023
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04112654
Start Date
June 29 2020
End Date
October 18 2023
Last Update
April 9 2024
Active Locations (1)
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1
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, France, 13009