Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05237700
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-02-14
First Post:
2022-01-20
Brief Title:
Steep Trendelenburg With or Without Lithotomy Positioning on the Operating Table
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Symptoms Functional Status and Quality of Life in Patients Undergoing Robotic-assisted and Laparoscopic Surgery in Steep Trendelenburg With or Without Lithotomy Positioning on the Operating Table
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-02
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:
None
Brief Summary:
Robotic assisted laparoscopic and laparoscopic gynecological colon-rectal and urological surgical procedures require that patients be placed in steep Trendelenburg positioning with or without lithotomy on operating table Steep Trendelenburg positioning is a variation of supine positioning in which the patient lies face up with the head and body tilted 250-450 downwards In lithotomy position the legs are placed in stirrups and knees bent flexing the leg on the operating table Lithotomy position can be graded in four levels according to what access the surgeon needs The arms are tucked and padded parallel to the body or the arms left on an arm board at an angel of less 900 Intraoperative peripheral nerve injury IPNI may follow incorrect positioning inadequate fixation or prolonged time in positioning IPNI is defined as new within 48 h sensory andor motor deficits and occurs following a combination of stretch ischemia andor compression during surgery and the injuries are either temporary or permanent In a systematic review we found that IPNI was related to lithotomy positioning with steep Trendelenburg in upper and lower extremity and the incidence of IPNI ranges from 016 to 10 IPNI after patient positioning on operating table has been described to result in pain and other symptoms as numbness weakness and tingling As demonstrated in our systematic review many of the patients with IPNI did not report pain which also supported in a recent review In addition our systematic review showed that the symptoms appeared immediately after surgical procedures and usually subside within three months The systematic review also demonstrates that a few patients continue to have pain orand other symptoms of IPNI up to one year following the surgery Furthermore previous studies have demonstrated that pain intensity and duration of pain influence daily activities and quality of life negatively
Positioning of the patients on operating table is a teamwork where the operating room nurse ORN has a pivotal role in order to protect the patients from experiencing injuries due to eg nerve compression and compromised circulation The purpose of this study is to increase the knowledge of IPNI related to positioning in patients undergoing robotic-assisted laparoscopic surgery and laparoscopic surgery As IPNI is an unclear phenomenon that can be difficult to diagnose we want to identify pain and other symptoms immediately after surgery that might have an impact on development of IPNI Several studies have reported persistent pain after surgery like neuropathic pain and that neuropathic pain occur soon after nerve lesion To get at a broader picture of IPNI we want to explore pain and other symptoms and to characterize how these symptoms might change and to identify risk factors associated with IPNI Therefore the aims of the present study are
1 Identify the incidence of IPNI up to 12 months after surgery
2 Explore pain other symptoms physical function and quality of life up to 12 months after surgery
3 Explore risk factors associated with IPNI
4 Explore associations between IPNI and quality of life
Positioning of the patients on operating table is a teamwork where the operating room nurse ORN has a pivotal role in order to protect the patients from experiencing injuries due to eg nerve compression and compromised circulation The purpose of this study is to increase the knowledge of IPNI related to positioning in patients undergoing robotic-assisted laparoscopic surgery and laparoscopic surgery As IPNI is an unclear phenomenon that can be difficult to diagnose we want to identify pain and other symptoms immediately after surgery that might have an impact on development of IPNI Several studies have reported persistent pain after surgery like neuropathic pain and that neuropathic pain occur soon after nerve lesion To get at a broader picture of IPNI we want to explore pain and other symptoms and to characterize how these symptoms might change and to identify risk factors associated with IPNI Therefore the aims of the present study are
1 Identify the incidence of IPNI up to 12 months after surgery
2 Explore pain other symptoms physical function and quality of life up to 12 months after surgery
3 Explore risk factors associated with IPNI
4 Explore associations between IPNI and quality of life
Detailed Description:
None
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