LaPAroscopic Low pRessure cOlorectal Surgery

Malignant or Benign Pathology Clinical Trial

— PAROS  

Official title:

LaPAroscopic Low pRessure cOlorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813797
• Other study ID #: CHUBX 2018/42
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: June 26, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: June 26, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant or Benign Pathology

Intervention

Device:
• Airseal®
Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg
• Standard Insufflation
Medical device set to the mode "Standard Insufflation", pressure adjustment between 12 and 15 mmHg

Locations

Country	Name	City	State
France	Chu de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of postoperative hospital stay	To determine the length of hospitalization	From surgery to the end of the hospitalization (max 30 days)
Secondary	Surgery time	To determine the surgery time	During surgery
Secondary	Appreciation of visual quality by surgeon	To determine the rate of visual quality during surgery: poor, medium or good quality	During surgery
Secondary	Impact of the use of microlaparoscopic instruments	To determine the rate of use of the microsurgery microlaparoscopic instruments (3mm)	During surgery
Secondary	Rates of conversion	Conversion to laparoscopy with standard pressure or conversion to laparotomy	During surgery
Secondary	Blood pressure (mmHg)	To examine the variation of blood pressure during surgery (at the beginning, middle and at the end)	During surgery
Secondary	Cardiac frequency (/ min)	To examine the variation of cardiac frequency during surgery (at the beginning, middle and at the end)	During surgery
Secondary	Volume replacement (mL)	To examine the volume replacement during surgery (at the beginning, middle and at the end)	During surgery
Secondary	Driving pressure (mmHg)	To examine the variation of drinving pressure during surgery (at the beginning, middle and at the end)	During surgery
Secondary	Oxygen saturation (%)	To examine the variation of SA02 (%) during surgery (at the beginning, middle and at the end)	During surgery
Secondary	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
Secondary	Surgical and medical morbidity	To analyse the cumulative Clavien-Dindo at 30 days	From surgery until 30 days (max 45 days)
Secondary	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
Secondary	Use of analgesics	To evaluate the rate of analgesics administrated (from step1 to step3)	An average of 5 days after the surgery
Secondary	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
Secondary	Time before the passage of first gas (days)	To determine the delay of the gas response	An average of 5 days after the surgery
Secondary	Time before mobilization (Days before 1st time sitting and standing)	To determine the delay before mobilization	An average of 5 days after the surgery
Secondary	Quality of cancer surgery	Rate of curative surgery (R0)	During surgery
Secondary	Number of lymph nodes examed	Number of lymph nodes examed during a cancer surgery	During surgery