Clinical trial NCT03813797: LaPAroscopic Low pRessure cOlorectal Surgery
Official title: LaPAroscopic Low pRessure cOlorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant or Benign Pathology
Keywords: Low Pressure
Laparoscopy
Colectomy
Pneumoperitoneum
AirSeal
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 138
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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Length of postoperative hospital stay
timeFrame: From surgery to the end of the hospitalization (max 30 days)
Secondary outcomes:
measure: Surgery time
timeFrame: During surgery
measure: Appreciation of visual quality by surgeon
timeFrame: During surgery
measure: Impact of the use of microlaparoscopic instruments
timeFrame: During surgery
measure: Rates of conversion
timeFrame: During surgery
measure: Blood pressure (mmHg)
timeFrame: During surgery
measure: Cardiac frequency (/ min)
timeFrame: During surgery
measure: Volume replacement (mL)
timeFrame: During surgery
measure: Driving pressure (mmHg)
timeFrame: During surgery
measure: Oxygen saturation (%)
timeFrame: During surgery
measure: Partial pressure of mean expired of carbon dioxide (mmHg)
timeFrame: During surgery
measure: Surgical and medical morbidity
timeFrame: From surgery until 30 days (max 45 days)
measure: Postoperative pain
timeFrame: 2 hours, 4 hours, 8 hours and 24 hours after the surgery
measure: Use of analgesics
timeFrame: An average of 5 days after the surgery
measure: Time before the passage of first stool (days)
timeFrame: An average of 5 days after the surgery
measure: Time before the passage of first gas (days)
timeFrame: An average of 5 days after the surgery
measure: Time before mobilization (Days before 1st time sitting and standing)
timeFrame: An average of 5 days after the surgery
measure: Quality of cancer surgery
timeFrame: During surgery
measure: Number of lymph nodes examed
timeFrame: During surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chu de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Quentin DENOST
role: PRINCIPAL_INVESTIGATOR
References:
citation: Celarier S, Monziols S, Celerier B, Assenat V, Carles P, Napolitano G, Laclau-Lacrouts M, Rullier E, Ouattara A, Denost Q. Low-pressure versus standard pressure laparoscopic colorectal surgery (PAROS trial): a phase III randomized controlled trial. Br J Surg. 2021 Aug 19;108(8):998-1005. doi: 10.1093/bjs/znab069.