Clinical trial NCT04112654: Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
Official title: Prospective Randomized Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Disease
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 pressure is 12 to 15 mmHg. The reduction of the intra-abdominal pressure minimizes the parietal trauma due to the insufflation and could lead to a reduction of the postoperative pains and could allow an earlier recovery. In this study, the investigator propose to evaluate the benefits of a low pressure insufflation (6-8 mmHg) with pressure-controlled insufflator in patients with a mild or malignant colon pathology requiring surgical colic resection. The main objective of the study is to demonstrate that the laparoscopic colic resection at low pressure reduces the theoretical hospital stay of one day compared to the conventional laparoscopy.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The theoretical hospital stay
timeFrame: from hospitalization day until hospital discharge, assessed up to 15 days
Secondary outcomes:
measure: Morbidity rate
timeFrame: 20 days post surgery
measure: Mortality rate
timeFrame: 20 days post surgery
measure: GastroIntestinal-Quality-of-Life Index (GIQLI)
timeFrame: 20 days and 3 months post surgery
measure: Short Form Health (SF12) score
timeFrame: 20 days and 3 months post surgery
measure: Pain score using self-report pain assessment tool (EVA)
timeFrame: From surgery to hospital discharge assessed up to 15 days, at 20 days and at 3 months post surgery
measure: Intestinal transit recovery time frame
timeFrame: From surgery to transit recovery assessed up to 15 days
measure: Nausea and vomiting incidence
timeFrame: From surgery to hospital discharge assessed up to 15 days
measure: Analgesic treatment incidence
timeFrame: From surgery to 3 months post surgery
measure: Real hospitalization duration
timeFrame: From hospitalization day until hospital discharge assessed up to 15 days
measure: Rehospitalization number
timeFrame: from hospital discharge assessed up to 15 days to 3 months post surgery
measure: Differential cost of patient care
timeFrame: From surgery to hospital discharge assessed up to 15 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Cecile DE CHAISEMARTIN, MD
role: PRINCIPAL_INVESTIGATOR
References: