LaPAroscopic Low pRessure cOlorectal Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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LaPAroscopic Low pRessure cOlorectal Surgery

Conditions
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Malignant or Benign Pathology

Intervention / Treatment
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* Device: Airseal®
* Device: Standard Insufflation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Low Pressure (5-7 mmHg)<br>Laparoscopic colectomy surgery with low pressure (5-7mmHg) | Device: Airseal®<br>* Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg<br>|
| Active Comparator: Arm B: Standard pressure (12-15 mmHg)<br>Laparoscopic colectomy surgery with standard pressure (12-15mmHg) | Device: Standard Insufflation<br>* Medical device set to the mode Standard Insufflation, pressure adjustment between 12 and 15 mmHg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of postoperative hospital stay | To determine the length of hospitalization | From surgery to the end of the hospitalization (max 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery time | To determine the surgery time | During surgery | 
| Appreciation of visual quality by surgeon | To determine the rate of visual quality during surgery: poor, medium or good quality | During surgery | 
| Impact of the use of microlaparoscopic instruments | To determine the rate of use of the microsurgery microlaparoscopic instruments (3mm) | During surgery | 
| Rates of conversion | Conversion to laparoscopy with standard pressure or conversion to laparotomy | During surgery | 
| Blood pressure (mmHg) | To examine the variation of blood pressure during surgery (at the beginning, middle and at the end) | During surgery | 
| Cardiac frequency (/ min) | To examine the variation of cardiac frequency during surgery (at the beginning, middle and at the end) | During surgery | 
| Volume replacement (mL) | To examine the volume replacement during surgery (at the beginning, middle and at the end) | During surgery | 
| Driving pressure (mmHg) | To examine the variation of drinving pressure during surgery (at the beginning, middle and at the end) | During surgery | 
| Oxygen saturation (%) | To examine the variation of SA02 (%) during surgery (at the beginning, middle and at the end) | 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) | During surgery | 
| Surgical and medical morbidity | To analyse the cumulative Clavien-Dindo at 30 days | 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) | 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) | 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 | An average of 5 days after the surgery | 
| Time before the passage of first gas (days) | To determine the delay of the gas response | An average of 5 days after the surgery | 
| Time before mobilization (Days before 1st time sitting and standing) | To determine the delay before mobilization | An average of 5 days after the surgery | 
| Quality of cancer surgery | Rate of curative surgery (R0) | During surgery | 
| Number of lymph nodes examed | Number of lymph nodes examed during a cancer surgery | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Pressure, Laparoscopy, Colectomy, Pneumoperitoneum, AirSeal