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NCT Number: NCT06154785

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis, Jette, Brussels Capital, Belgium

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Colonic resection (right or left, subtotal or total) performed for benign or malignant pathology
  • Rectal resection 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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Hélène HMM MAILLOU-MARTINAUD

CONTACT

[email protected]

+ 33 (0)6 68 68 68 05

Quentin QD DENOST, Prof

CONTACT

[email protected]

+33(0)5 47 50 15 75

Sponsors and collaborators

Lead sponsor

Bordeaux Colorectal Institute Academy

Other

Registry information

Official study title

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

Acronym: CROSS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2023
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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