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JOURNAL ONKOLOGIE – STUDIE
CROSS

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

Rekrutierend

NCT-Nummer:
NCT06154785

Studienbeginn:
Dezember 2023

Letztes Update:
31.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Pneumoperitoneum

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Bordeaux Colorectal Institute Academy

Collaborator:
-

Kontakt

Quentin QD DENOST, Prof
Kontakt:
Phone: +33(0)5 47 50 15 75
E-Mail: q.denost@bordeaux-colorectal-institute.fr» Kontaktdaten anzeigen
Hélène HMM MAILLOU-MARTINAUD
Kontakt:
Phone: + 33 (0)6 68 68 68 05
E-Mail: h.maillou.martinaud@bordeaux-colorectal-institute.fr» Kontaktdaten anzeigen

Studienlocations
(3 von 19)

St. Georg Klinikum Eisenach
99817 Eisenach
(Thüringen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Markus MM MILLE
Phone: +49 3691 6980
E-Mail: mille.markus@stgeorgklinikum.de» Ansprechpartner anzeigen
El Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"
C1000 Buenos-Aires
ArgentinaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Nicolas NA AVELLANEDA
Phone: +54 11 5299 0247
E-Mail: n.avellaneda86@gmail.com» Ansprechpartner anzeigen
Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
33 000 Bordeaux
FranceRekrutierend» Google-Maps
Ansprechpartner:
Quentin QD DENOST, Prof
Phone: +33 (0)5 47 50 15 75
E-Mail: q.denost@bordeaux-colorectal-institute.fr» Ansprechpartner anzeigen
Division of Colon and Rectal Surgery
20089 Milan
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Antonino AS SPINELLI
Phone: +39 02 82 24 47 72
E-Mail: antonino.spinelli@hunimed.eu» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Laparoscopy is currently the gold standard for the vast majority of abdominal surgeries, and

especially for colectomy for cancer or benign diseases. There are many data showing the

benefits of the laparoscopic approach to colectomy in terms of morbidity, post-operative pain

and analgesic consumption, length of hospital stay, cosmetic results, and improved patient

satisfaction. In 2002, consensus European guidelines recommended insufflating at the lowest

pressure that still provides sufficient exposure. Considering these results, low-pressure

laparoscopy is one of the alternatives that have been developed to do away with the

complications of the pneumoperitoneum while retaining its advantages.

However, other factors may influence the outcomes of the low-pressure pneumoperitoneum such

as the use of humidification and warming gaz, robotic or microsurgical instrumentation,

neuromuscular blockade, patient positioning, pre-stretching of the abdominal wall,

ventilation-induced changes, and probably individual patient factors like obesity. These

parameters could not be separately tested in randomized trial. We should consider all these

parameters in a prospective international registry in order to optimize the benefit of

low-pressure pneumoperitoneum in post-operative recovery.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age ≥ 18 years old

- Colonic resection (right or left) performed for benign or malignant pathology

- Partial or Total mesorectal Excision (PME or TME) with or without stoma for benign or

malignant pathology

- Laparoscopic or robotic procedure

- Surgery under low stable pressure pneumoperitoneum with AirSeal

- Patient who benefits by medicare system

- Oral agreement after reading information letter

Exclusion Criteria:

- Laparotomy procedure

- Associated resection (except appendectomy or liver biopsy)

- Transverse colectomy

- Emergency procedure

- Pelvic sepsis

- Pregnancy or breast feeding period

- Legal incapacity or physical, psychological social or geographical status interfering

with the patient's ability to agree to participate in the study

- Persons deprived of liberty or under guardianship

Studien-Rationale

Primary outcome:

1. To assess the impact of the stable low-pressure approach (using Airseal Insufflator) and its associated parameters into the the early rehabilitation program after colorectal surgery on length of stay. (Time Frame - From the surgery to the end of the hospitalization (max 30 days)):
Evaluate the Length of hospital stay after colorectal surgery.



Secondary outcome:

1. The impact of stable low pressure on the postoperative pain after colorectal surgery (Time Frame - At 24 hours after the end of the surgery):
Pain is evaluated (Visual Analgesic Scale (Vas scores from 0 (no pain) to 10 (hurst worst))

2. The impact of stable low pressure on the opioid consumption after colorectal surgery (Time Frame - From the surgery to the end of the hospitalization (max 30 days)):
Evaluate the impact on the opioid consumption after colorectal surgery;

3. The impact of the different mini-invasive approaches on the feasibility and benefit of low stable pressure (Time Frame - From the surgery to the end of the hospitalization (max 30 days)):
Evaluate the impact of robotic, laparoscopic +/- microsurgical instrument, 3D laparoscopic vision surgery

4. The Post-operative Surgical and Medical morbidity (Time Frame - From the surgery to the end of the hospitalization (max 30 days)):
Post operative Surgical and Medical morbidity according to the Clavien-Dindo Classification

5. The impact of the anesthetic management on the feasibility and benefit of low stable pressure (Time Frame - From the surgery to the end of the hospitalization (max 30 days)):
Evaluate the impact of drugs, deep neuromuscular blockade, ventilation characteristics, intraoperative nociception monitoring, patient positioning, pre-stretching of the abdominal wall, and individual patient factors

6. The Surgical and Medical morbidity at 30 days (Time Frame - At 30 days after the end of the surgery):
Surgical and Medical morbidity at 30 days according to the Clavien-Dindo Classification

Quelle: ClinicalTrials.gov


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