Malignant or Benign Pathology
Conditions
Keywords
Low Pressure, Laparoscopy, Colectomy, Pneumoperitoneum, AirSeal
Brief summary
Laparoscopy by its mini-invasive character has revolutionized abdominal and colorectal surgery but certain limitations remains (post-operative pain due to pneumoperitoneum, pneumoperitoneum stability, visibility during bleeding, smoke evacuation). The medical device for continuous pressure insufflation during laparoscopic procedures Airseal® would allow the maintenance of pneumoperitoneum at a lower pressure. The stable low pressure (7mmHg) is described in the literature for 15 years as the best way to reduce scapular pain, but until the marketing of Airseal, working at 7mmHg was not possible because the space of work was not stable. Moreover, this device makes it possible to obtain a better vision because of the evacuation of the fumes potentially leading to a reduction in the operating time.
Detailed description
This research focuses on a medical device that allows the surgeon to perform the surgical procedure at a lower pressure than usual. The main objective of this study is to compare the duration of hospitalization of patients with laparoscopic colectomy at low pressure (5-7 mmHg) versus standard pressure (12-15 mmHg) It is a prospective randomized monocentric double blind study
Interventions
DEVICEAirseal®
Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg
DEVICEStandard Insufflation
Medical device set to the mode Standard Insufflation, pressure adjustment between 12 and 15 mmHg
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The study will be carried out: * Blind patient: The patient will not know the group he belongs to, in order to minimize the bias related to the self-evaluation of postoperative pain * Blind for the outpatient evaluator: the surgeon will blindly evaluate the primary endpoint: patient's discharge criteria. This evaluator surgeon will be different from the operator surgeon The blind will minimize the measurement bias.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Colonic resection (right or left) performed for benign or malignant pathology * Laparoscopic procedure * Informed consent signed * Social Insurance
Exclusion criteria
* Laparotomy procedure * Associated resection (except appendectomy or liver biopsy * Emergency procedure * Pelvic sepsis * Pregnant or breast-feeding woman. * Persons deprived of liberty or under guardianship * Impossibility for compliance to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of postoperative hospital stay | From surgery to the end of the hospitalization (max 30 days) | To determine the length of hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appreciation of visual quality by surgeon | During surgery | To determine the rate of visual quality during surgery: poor, medium or good quality |
| Impact of the use of microlaparoscopic instruments | During surgery | To determine the rate of use of the microsurgery microlaparoscopic instruments (3mm) |
| Rates of conversion | During surgery | Conversion to laparoscopy with standard pressure or conversion to laparotomy |
| Blood pressure (mmHg) | During surgery | To examine the variation of blood pressure during surgery (at the beginning, middle and at the end) |
| Cardiac frequency (/ min) | During surgery | To examine the variation of cardiac frequency during surgery (at the beginning, middle and at the end) |
| Volume replacement (mL) | During surgery | To examine the volume replacement during surgery (at the beginning, middle and at the end) |
| Driving pressure (mmHg) | During surgery | To examine the variation of drinving pressure during surgery (at the beginning, middle and at the end) |
| Oxygen saturation (%) | During surgery | To examine the variation of SA02 (%) during surgery (at the beginning, middle and at the end) |
| Surgery time | During surgery | To determine the surgery time |
| Surgical and medical morbidity | From surgery until 30 days (max 45 days) | To analyse the cumulative Clavien-Dindo at 30 days |
| Postoperative pain | 2 hours, 4 hours, 8 hours and 24 hours after the surgery | Pain was evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst) |
| Use of analgesics | An average of 5 days after the surgery | To evaluate the rate of analgesics administrated (from step1 to step3) |
| Time before the passage of first stool (days) | An average of 5 days after the surgery | To determine the delay of the laxation and gas response |
| Time before the passage of first gas (days) | An average of 5 days after the surgery | To determine the delay of the gas response |
| Time before mobilization (Days before 1st time sitting and standing) | An average of 5 days after the surgery | To determine the delay before mobilization |
| Quality of cancer surgery | During surgery | Rate of curative surgery (R0) |
| Number of lymph nodes examed | During surgery | Number of lymph nodes examed during a cancer surgery |
| Partial pressure of mean expired of carbon dioxide (mmHg) | During surgery | To examine the variation PECO2 (mmHg) during surgery (at the beginning, middle and at the end) |
Countries
France
Outcome results
None listed