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The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| International cohort | This is an international cohort (France and other international centers) which consists of including patients undergoing colorectal surgery performed at low pressure for benign or malignant pathology.This stage 2b cohort study is a pilot study assessing the best operative association with stable low-pressure pneumoperitoneum in order to optimize postoperative outcomes after mini invasive colorectal surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluate the Length of hospital stay after colorectal surgery. | From the surgery to the end of the hospitalization (max 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of stable low pressure on the postoperative pain after colorectal surgery | Pain is evaluated (Visual Analgesic Scale (Vas scores from 0 (no pain) to 10 (hurst worst)) | At 24 hours after the end of the surgery |
| The impact of stable low pressure on the opioid consumption after colorectal surgery |
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Inclusion Criteria:
Exclusion Criteria:
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This cohort study is a pilot study assessing the best operative association with stable low-pressure pneumoperitoneum in order to optimize postoperative outcomes after mini-invasive colorectal surgery. The use of robotic or microsurgical instrumentation, neuromuscular blockade, patient positioning, pre-stretching of the abdominal wall and ventilation-parameters could not be separately tested in randomized trial.
In this pilot study, we aim to include 300 patients with low stable pneumoperitoneum with Colorectal surgery.
All patient assessements will be done according to the sites standard of care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quentin QD DENOST, Prof | Contact | +33(0)5 47 50 15 75 | q.denost@bordeaux-colorectal-institute.fr | |
| Hélène HMM MAILLOU-MARTINAUD | Contact | + 33 (0)6 68 68 68 05 | h.maillou.martinaud@bordeaux-colorectal-institute.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis | Recruiting | Jette | Brussels Capital | 1090 | Belgium |
There are no plans to share individual participant data (IPD) with other researchers
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Evaluate the impact on the opioid consumption after colorectal surgery; |
| From the surgery to the end of the hospitalization (max 30 days) |
| The impact of the different mini-invasive approaches on the feasibility and benefit of low stable pressure | Evaluate the impact of robotic, laparoscopic +/- microsurgical instrument, 3D laparoscopic vision surgery | From the surgery to the end of the hospitalization (max 30 days) |
| The Post-operative Surgical and Medical morbidity | Post operative Surgical and Medical morbidity according to the Clavien-Dindo Classification | From the surgery to the end of the hospitalization (max 30 days) |
| The impact of the anesthetic management on the feasibility and benefit of low stable pressure | 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 | From the surgery to the end of the hospitalization (max 30 days) |
| The Surgical and Medical morbidity at 30 days | Surgical and Medical morbidity at 30 days according to the Clavien-Dindo Classification | At 30 days after the end of the surgery |
| Hôpital Jean Minoz | Not yet recruiting | Besançon | 25030 | France |
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| Clinique Tivoli-Ducos - Bordeaux Colorectal Institute | Recruiting | Bordeaux | 33 000 | France |
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| Hôpital Albert Michallon | Not yet recruiting | La Tronche | 38700 | France |
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| Hôpital Bicêtre | Not yet recruiting | Le Kremlin-Bicêtre | 94270 | France |
|
| Hôpital Nord-Marseille | Recruiting | Marseille | 13915 | France |
|
| Clinique Hartmann | Not yet recruiting | Neuilly-sur-Seine | 92200 | France |
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| Hopital Saint-Louis | Not yet recruiting | Paris | 75010 | France |
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| Hôpital Saint-Antoine | Not yet recruiting | Paris | 75012 | France |
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| Hôpital Européen Georges Pompidou | Not yet recruiting | Paris | 75908 | France |
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| Hôpital Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
|
| Hopital Charles Nicolle | Recruiting | Rouen | 76031 | France |
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| St. Georg Klinikum Eisenach | Not yet recruiting | Eisenach | 99817 | Germany |
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| Division of Colon and Rectal Surgery | Recruiting | Milan | 20089 | Italy |
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| Academic Medical Center | Recruiting | Amsterdam | 1105 AZ | Netherlands |
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| Hospital General Universitario Gregorio | Recruiting | Madrid | 28007 | Spain |
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| Hôpitaux Universitaires de Genève | Recruiting | Geneva | 1205 | Switzerland |
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| Nhs Fundation Trust | Not yet recruiting | Manchester | M139WL | United Kingdom |
|
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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