Colonic Disease
Conditions
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.
Interventions
PROCEDUREConventional pressure laparoscopy
Conventional pressure laparoscopy using conventional insufflator AirSeal®
PROCEDURELow pressure laparoscopy
Low pressure laparoscopy using pressure-controlled insufflator AirSeal®
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The theoretical hospital stay | from hospitalization day until hospital discharge, assessed up to 15 days | The theoretical hospital stay in days (calculated from the day of the surgery to the theoretical day of discharge according to predefined exit criteria) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | 20 days post surgery | Dead patient listing |
| GastroIntestinal-Quality-of-Life Index (GIQLI) | 20 days and 3 months post surgery | GastroIntestinal-Quality-of-Life Index (GIQLI) questionnaire, 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144. |
| Short Form Health (SF12) score | 20 days and 3 months post surgery | This questionnaire is an abbreviated version of the Medical Outcomes Study Short-Form General Health Survey (SF-36) contains only 12 items out of 36 with minimum score 0 (bad quality life) and maximum score at 100 (good quality life). |
| Pain score using self-report pain assessment tool (EVA) | From surgery to hospital discharge assessed up to 15 days, at 20 days and at 3 months post surgery | EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable) |
| Intestinal transit recovery time frame | From surgery to transit recovery assessed up to 15 days | Period duration from surgery to intestinal gas recovery time (in days) |
| Morbidity rate | 20 days post surgery | Morbidity evaluated according Dindo-clavien classification |
| Analgesic treatment incidence | From surgery to 3 months post surgery | Non-morphine and morphine analgesic consumption |
| Real hospitalization duration | From hospitalization day until hospital discharge assessed up to 15 days | Real hospitalization duration (actual patient discharge date based on non-medical criteria) |
| Rehospitalization number | from hospital discharge assessed up to 15 days to 3 months post surgery | Rehospitalization listing |
| Differential cost of patient care | From surgery to hospital discharge assessed up to 15 days | According operating room occupation and real hospital stay |
| Nausea and vomiting incidence | From surgery to hospital discharge assessed up to 15 days | Nausea and vomiting listing |
Countries
France
Outcome results
None listed