Skip to main content
OpenTrials
Completed

NCT Number: NCT03813797

LaPAroscopic Low pRessure cOlorectal Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant or Benign Pathology Digestive System Diseases Peritoneal Diseases Pneumoperitoneum

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Bordeaux

Bordeaux, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Airseal®

Device

Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg

Standard Insufflation

Device

Medical device set to the mode "Standard Insufflation", pressure adjustment between 12 and 15 mmHg

Primary outcomes

  1. Length of postoperative hospital stay

    Time frame: From surgery to the end of the hospitalization (max 30 days)

    To determine the length of hospitalization

Secondary outcomes

  1. Surgery time

    Time frame: During surgery

    To determine the surgery time

  2. Appreciation of visual quality by surgeon

    Time frame: During surgery

    To determine the rate of visual quality during surgery: poor, medium or good quality

  3. Impact of the use of microlaparoscopic instruments

    Time frame: During surgery

    To determine the rate of use of the microsurgery microlaparoscopic instruments (3mm)

  4. Rates of conversion

    Time frame: During surgery

    Conversion to laparoscopy with standard pressure or conversion to laparotomy

  5. Blood pressure (mmHg)

    Time frame: During surgery

    To examine the variation of blood pressure during surgery (at the beginning, middle and at the end)

  6. Cardiac frequency (/ min)

    Time frame: During surgery

    To examine the variation of cardiac frequency during surgery (at the beginning, middle and at the end)

  7. Volume replacement (mL)

    Time frame: During surgery

    To examine the volume replacement during surgery (at the beginning, middle and at the end)

  8. Driving pressure (mmHg)

    Time frame: During surgery

    To examine the variation of drinving pressure during surgery (at the beginning, middle and at the end)

  9. Oxygen saturation (%)

    Time frame: During surgery

    To examine the variation of SA02 (%) during surgery (at the beginning, middle and at the end)

  10. Partial pressure of mean expired of carbon dioxide (mmHg)

    Time frame: During surgery

    To examine the variation PECO2 (mmHg) during surgery (at the beginning, middle and at the end)

  11. Surgical and medical morbidity

    Time frame: From surgery until 30 days (max 45 days)

    To analyse the cumulative Clavien-Dindo at 30 days

  12. Postoperative pain

    Time frame: 2 hours, 4 hours, 8 hours and 24 hours after the surgery

    Pain was evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst)

  13. Use of analgesics

    Time frame: An average of 5 days after the surgery

    To evaluate the rate of analgesics administrated (from step1 to step3)

  14. Time before the passage of first stool (days)

    Time frame: An average of 5 days after the surgery

    To determine the delay of the laxation and gas response

  15. Time before the passage of first gas (days)

    Time frame: An average of 5 days after the surgery

    To determine the delay of the gas response

  16. Time before mobilization (Days before 1st time sitting and standing)

    Time frame: An average of 5 days after the surgery

    To determine the delay before mobilization

  17. Quality of cancer surgery

    Time frame: During surgery

    Rate of curative surgery (R0)

  18. Number of lymph nodes examed

    Time frame: During surgery

    Number of lymph nodes examed during a cancer surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: PAROS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2019
Registry last updated
Oct 8, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.