LaPAroscopic Low pRessure cOlorectal Surgery (PAROS)

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.

Study Overview

• Status: Completed
• Conditions: Malignant or Benign Pathology
• Intervention / Treatment: Device: Airseal®; Device: Standard Insufflation

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Low Pressure (5-7 mmHg); Laparoscopic colectomy surgery with low pressure (5-7mmHg)	Device: Airseal®; Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg
Active Comparator: Arm B: Standard pressure (12-15 mmHg); Laparoscopic colectomy surgery with standard pressure (12-15mmHg)	Device: Standard Insufflation; Medical device set to the mode "Standard Insufflation", pressure adjustment between 12 and 15 mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of postoperative hospital stay	To determine the length of hospitalization	From surgery to the end of the hospitalization (max 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery time	To determine the surgery time	During surgery
Appreciation of visual quality by surgeon	To determine the rate of visual quality during surgery: poor, medium or good quality	During surgery
Impact of the use of microlaparoscopic instruments	To determine the rate of use of the microsurgery microlaparoscopic instruments (3mm)	During surgery
Rates of conversion	Conversion to laparoscopy with standard pressure or conversion to laparotomy	During surgery
Blood pressure (mmHg)	To examine the variation of blood pressure during surgery (at the beginning, middle and at the end)	During surgery
Cardiac frequency (/ min)	To examine the variation of cardiac frequency during surgery (at the beginning, middle and at the end)	During surgery
Volume replacement (mL)	To examine the volume replacement during surgery (at the beginning, middle and at the end)	During surgery
Driving pressure (mmHg)	To examine the variation of drinving pressure during surgery (at the beginning, middle and at the end)	During surgery
Oxygen saturation (%)	To examine the variation of SA02 (%) during surgery (at the beginning, middle and at the end)	During surgery
Partial pressure of mean expired of carbon dioxide (mmHg)	To examine the variation PECO2 (mmHg) during surgery (at the beginning, middle and at the end)	During surgery
Surgical and medical morbidity	To analyse the cumulative Clavien-Dindo at 30 days	From surgery until 30 days (max 45 days)
Postoperative pain	Pain was evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst)	2 hours, 4 hours, 8 hours and 24 hours after the surgery
Use of analgesics	To evaluate the rate of analgesics administrated (from step1 to step3)	An average of 5 days after the surgery
Time before the passage of first stool (days)	To determine the delay of the laxation and gas response	An average of 5 days after the surgery
Time before the passage of first gas (days)	To determine the delay of the gas response	An average of 5 days after the surgery
Time before mobilization (Days before 1st time sitting and standing)	To determine the delay before mobilization	An average of 5 days after the surgery
Quality of cancer surgery	Rate of curative surgery (R0)	During surgery
Number of lymph nodes examed	Number of lymph nodes examed during a cancer surgery	During surgery

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Quentin DENOST, University Hospital, Bordeaux

Publications and helpful links

General Publications

• Celarier S, Monziols S, Celerier B, Assenat V, Carles P, Napolitano G, Laclau-Lacrouts M, Rullier E, Ouattara A, Denost Q. Low-pressure versus standard pressure laparoscopic colorectal surgery (PAROS trial): a phase III randomized controlled trial. Br J Surg. 2021 Aug 19;108(8):998-1005. doi: 10.1093/bjs/znab069.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): May 25, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Pneumoperitoneum; Colectomy; Laparoscopy; AirSeal; Low Pressure
• Other Study ID Numbers: CHUBX 2018/42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No