Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742881
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2021-01-22
Brief Title:
Low Impact Laparoscopic in Colorectal Resection - PAROS2
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Low Impact Laparoscopic in Colorectal Resection a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAROS2
Brief Summary:
To improve post-operative recovery the concept of Low Impact Laparoscopy was developed in colo-rectal surgery with associating low-pressure pneumoperitoneum and microlaparoscopic surgery A phase III double-blind prospective randomized controlled multi-centric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain at 24 hours without taking opioids It is compared with low-pressure laparoscopy with classical laparoscopic instruments in patients undergoing colorectal surgeries
Detailed Description:
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 which showed that low-pressure laparoscopic colectomy for benign or malign disease was feasible and safe with shorter length of stay and decrease post-operative pain with reduction of analgesic consumption
Minimally invasive technics like microlaparoscopic surgery developed last years had also an impact by decreasing post operative pain The Low Impact Laparoscopy concept was developed in colo-rectal surgery with the association of low-pressure pneumoperitoneum and microlaparoscopic surgery
The aim of the study is to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain without taking opioids compared with low-pressure laparoscopy with classical laparoscopic instruments in patients undergoing colorectal surgeries
The design of this study is a phase III double-blind prospective randomized controlled multi-centric trial The primary endpoint is the rate of patients with postoperative pain defined 24h after the end of the intervention by visual analog scale VAS 3 without taking opioids analgesics level II or III Secondary outcomes are operating time conversion rate in normal pressure laparoscopy or in laparotomy morbidity at 3 months quality of oncological surgery length of stay impact of microlaparoscopic instruments of aesthetic appearance at 3 months
The primary end point will be assessed at 24h after the end of the surgery by a blind nurse evaluating the pain intensity After discharge of the hospital patients will be followed with postoperative consultation at 1 month and 3 month
To improve recovery after colorectal laparoscopic surgery it was realized a first study PAROS which showed that low-pressure laparoscopic colectomy for benign or malign disease was feasible and safe with shorter length of stay and decrease post-operative pain with reduction of analgesic consumption
Minimally invasive technics like microlaparoscopic surgery developed last years had also an impact by decreasing post operative pain The Low Impact Laparoscopy concept was developed in colo-rectal surgery with the association of low-pressure pneumoperitoneum and microlaparoscopic surgery
The aim of the study is to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain without taking opioids compared with low-pressure laparoscopy with classical laparoscopic instruments in patients undergoing colorectal surgeries
The design of this study is a phase III double-blind prospective randomized controlled multi-centric trial The primary endpoint is the rate of patients with postoperative pain defined 24h after the end of the intervention by visual analog scale VAS 3 without taking opioids analgesics level II or III Secondary outcomes are operating time conversion rate in normal pressure laparoscopy or in laparotomy morbidity at 3 months quality of oncological surgery length of stay impact of microlaparoscopic instruments of aesthetic appearance at 3 months
The primary end point will be assessed at 24h after the end of the surgery by a blind nurse evaluating the pain intensity After discharge of the hospital patients will be followed with postoperative consultation at 1 month and 3 month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None