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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
138
Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg
Medical device set to the mode "Standard Insufflation", pressure adjustment between 12 and 15 mmHg
Chu de Bordeaux
Bordeaux, France
Length of postoperative hospital stay
To determine the length of hospitalization
Time frame: From surgery to the end of the hospitalization (max 30 days)
Surgery time
To determine the surgery time
Time frame: During surgery
Appreciation of visual quality by surgeon
To determine the rate of visual quality during surgery: poor, medium or good quality
Time frame: During surgery
Impact of the use of microlaparoscopic instruments
To determine the rate of use of the microsurgery microlaparoscopic instruments (3mm)
Time frame: During surgery
Rates of conversion
Conversion to laparoscopy with standard pressure or conversion to laparotomy
Time frame: During surgery
Blood pressure (mmHg)
To examine the variation of blood pressure during surgery (at the beginning, middle and at the end)
Time frame: During surgery
Cardiac frequency (/ min)
To examine the variation of cardiac frequency during surgery (at the beginning, middle and at the end)
Time frame: During surgery
Volume replacement (mL)
To examine the volume replacement during surgery (at the beginning, middle and at the end)
Time frame: During surgery
Driving pressure (mmHg)
To examine the variation of drinving pressure during surgery (at the beginning, middle and at the end)
Time frame: During surgery
Oxygen saturation (%)
To examine the variation of SA02 (%) during surgery (at the beginning, middle and at the end)
Time frame: During surgery
Partial pressure of mean expired of carbon dioxide (mmHg)
To examine the variation PECO2 (mmHg) during surgery (at the beginning, middle and at the end)
Time frame: During surgery
Surgical and medical morbidity
To analyse the cumulative Clavien-Dindo at 30 days
Time frame: From surgery until 30 days (max 45 days)
Postoperative pain
Pain was evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst)
Time frame: 2 hours, 4 hours, 8 hours and 24 hours after the surgery
Use of analgesics
To evaluate the rate of analgesics administrated (from step1 to step3)
Time frame: An average of 5 days after the surgery
Time before the passage of first stool (days)
To determine the delay of the laxation and gas response
Time frame: An average of 5 days after the surgery
Time before the passage of first gas (days)
To determine the delay of the gas response
Time frame: An average of 5 days after the surgery
Time before mobilization (Days before 1st time sitting and standing)
To determine the delay before mobilization
Time frame: An average of 5 days after the surgery
Quality of cancer surgery
Rate of curative surgery (R0)
Time frame: During surgery
Number of lymph nodes examed
Number of lymph nodes examed during a cancer surgery
Time frame: During surgery
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