Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Colonic Neoplasms

Pneumoperitoneum

Peritoneal Diseases

Gastrointestinal Diseases

Oculocerebral Syndrome With Hypopigmentation

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.

Quentin QD DENOST, Prof

Hélène HMM MAILLOU-MARTINAUD

Nicolas NA AVELLANEDA

Ellen EV VAN EETVELDE

Ellen EVE VAN EETVELDE

Zaher ZL LAKKIS

Zaher ZL Lakkis

Quentin QD DENOST

Bertrand BT TRILLING

Antoine AB BROUQUET

Laura LBB BEYER-BERJOT

Panis YP Yves

Yves YP PANIS

Léon LM MAGGIORI

Jérémie JL Lefevre

Jérémie JL LEFEVRE

Gilles GM MANCEAU

Eddy EC COTTE

Jean-Jacques JJT TUECH

Markus MM MILLE

Antonino AS SPINELLI

Roel RH HOMPES

Patricia PT TEJEDOR

Frederic FR RIS

Deena DH HARJI

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.

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)

There are no plans to share individual participant data (IPD) with other researchers

Evaluate the Length of hospital stay after colorectal surgery.

Pain is evaluated (Visual Analgesic Scale (Vas scores from 0 (no pain) to 10 (hurst worst))

Evaluate the impact on the opioid consumption after colorectal surgery;

Evaluate the impact of robotic, laparoscopic +/- microsurgical instrument, 3D laparoscopic vision surgery

Post operative Surgical and Medical morbidity according to the Clavien-Dindo Classification

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

Surgical and Medical morbidity at 30 days according to the Clavien-Dindo Classification

Bordeaux Colorectal Institute Academy

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Low pressure pneumoperitoneum and use warm and humidified CO2 insufflation

low pressure pneumoperitoneum (5-7mmHg) and use warm (35°C), humidified (95% relative humidity) CO2 insufflation.

Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation

low pressure pneumoperitoneum (5-7mmHg), and use standard room temperature with dry insufflation.

Laparoscopic surgery under low pressure and conventional Insufflation

Quentin DENOST, Prof

Stéphanie GUILLON

Quentin DENOST

Laura BEYER-BERJOT

To improve post-operative recovery, medical device was developed combining low-pressure pneumoperitoneum and heated and humidified Carbon Dioxide (95˚F \& 95% RH) during laparoscopic surgery to reduce the harmful effects of cold/dry insufflation.

A double-blind, prospective, randomized, controlled, monocentric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with warm and humidified gaz on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with cold and dry gaz in patients undergoing colorectal surgeries.

Laparoscopy is the gold standard in colorectal surgery with many benefits in term of morbidity, post-operative pain and analgesic consumption. However, the pneumoperitoneum created for the laparoscopy has several negatives impact and limits (specific pain following abdominal distension, visibility, physiological repercussion).

To improve recovery after colorectal laparoscopic surgery it was realized a first study (PAROS 1) which showed that low-pressure laparoscopic colectomy for benign or malign disease was feasible and safe with shorter length of stay (3 vs. 4 days; p=0.001), and decrease post-operative pain (VAS ≤ 3 à H8: 87% vs. 72% ; p=0.039) with reduction of analgesic consumption (step II analgesics: 73% vs. 88% ; p=0.032 and step 3 analgesics: (10% vs.23% ; p=0.042) (Br J Surg. 2021 Aug 19;108(8):998-1005) Simultaneously, the development of humidification medical device, referring to the administration of heated and humidified CO2 during laparoscopic surgery, aims to reduce the effects of cell drying and evaporative heat loss when the body is exposed to cold CO2. and dry during laparoscopic surgery. The state of the CO2 traditionally used during laparoscopic surgery and the ambient air during open surgery is very different from that of the human body, as it directly extracts heat and humidity from the already fragile patient.

The introduction of heated and humidified CO2 provides an environment that reflects the physiological state of the peritoneum.

Added to the benefits of low pressure, the advantages of surgical humidification seem very positive. During surgery, surgical humidification would reduce the incidence of perioperative hypothermia, improve local tissue oxygenation and local tissue perfusion. After surgery, it would improve core body temperature, reduce local peritoneal inflammation, surgical site infection rate and recovery time. The benefits of a warmed and humidified CO2 also seem very positive in terms of reducing postoperative pain and analgesic consumption. In the long term, it would reduce adhesion formation, tumor burden, metastases, and economic cost.

The aim of the study is to assess the impact of low-pressure pneumoperitoneum with warm and humidified CO2 insufflation on post-operative pain without taking opioids, compared with low-pressure laparoscopy with cold and dry gas insufflation.

Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation

Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection With Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone

Pain is evaluated with the Visual Analogue Scale (VAS, from 0 (no pain) to 10 (hurts worst)

Conversion rate in normal pressure (12-15mmHg) and laparotomy

Evaluation of Heart rate at different times during surgery : "after anesthetic intubation", "15 min after insufflation", and "5 min after exsufflation".

Evaluation of arterial pressure at different times during surgery : "after anesthetic intubation", "15 min after insufflation", and "5 min after exsufflation"

Evaluation of ambient theatre temperature and body temperature at different times during surgery : "before incision", "15 min after insufflation",then every hour and the last temperature reading at the end of the surgery.

c-reactive protein levels in serum over 4 days post-surgery

To analyse the cumulative morbidity at 30 days after surgery and at 3 months of follow-up according to the Clavien-DINDO classification

Rate of cumulative surgery R0 resection for oncologic surgery

Pain was evaluated with the Visual Analogue Scale (VAS, from 0 (no pain) to 10 (hurts worst)) during hospital stay and until 30 days using a patient subject diary every day and immediately before each use of pain medication

To analyse the rate of analgesics using a patient subject diary

The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The questionnaire is a self-report survey that measures quality of life across 5 domains: : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state

- The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, numbered from 0 to 100.

( 100 means "the best health you can imagine" and 0 means "the worst health you can imagine".)

Study the predictive factors of postoperative pain (VAS\>3), 24 hours and 30 days after the surgery. (Visual Analogue Scale (VAS), from 0 (no pain) to 10 (hurts worst)).

To identify predictive factors of opioid intake (second step and/or third step of the Who analgesic ladder),24 hours and 30 days after the surgery.

Comparison of the clinical and perioperative data from patients who did or did not consume opioids after surgery. The differences in proportions will be compared.

Colorectal procedure will be performed by da Vinci SP® Surgical System

da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision

Robotic Assisted Surgery

Kathryn Wine

To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.

Primary Performance:

* The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion\* to an alternate approach comprises conversion to open, multiport laparoscopic\*\*, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach.

  * Performing an extracorporeal anastomosis is not considered a conversion \*\* Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance

Primary Safety:

• The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period

da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease

Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.

Safety defined as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)	NCT06154785	Colorectal Surg... Benign or Malig...		-	Bordeaux Colorectal Institute Academy
Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation	NCT05934981	Colorectal Surg... Benign or Malig...	Laparoscopic su... Laparoscopic su...	18 Years -	Bordeaux Colorectal Institute Academy
Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation	NCT05934981	Colorectal Surg... Benign or Malig...	Laparoscopic su... Laparoscopic su...	18 Years -	Bordeaux Colorectal Institute Academy
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures	NCT04403022	Colorectal Canc... Benign or Malig...	Robotic Assiste...	18 Years -	Intuitive Surgical
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures	NCT04403022	Colorectal Canc... Benign or Malig...	Robotic Assiste...	18 Years -	Intuitive Surgical

Spots Global Cancer Trial Database for benign or malignant rectal or colon tumors