Steep Trendelenburg With or Without Lithotomy Positioning on the Operating Table.

NCT ID: NCT05237700

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2024-12-31

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 and/or motor deficits and occurs following a combination of stretch, ischemia and/or 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 0.16% 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 or/and 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 e.g. 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.

Conditions

Peripheral Neuropathy; Intraoperative Injury; Intraoperative Complications; Patient Positioning; Operating Table

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Trendelenburg with lithotomy positioning on the operating table.

The patient is positioned in Trendelenburg with lithotomy positioning on the operating table.

Patient positioning on operating table

Intervention Type: OTHER

The patients are either positioned in Trendelenburg with lithotomy positioning or in Trendelenburg without lithotomy positioning on the operating table when undergoing robotic assisted laparoscopic surgery or laparoscopic surgery.

Trendelenburg without lithotomy positioning on the operating table.

The patient is positioned in Trendelenburg without lithotomy positioning on the operating table.

Patient positioning on operating table

Intervention Type: OTHER

The patients are either positioned in Trendelenburg with lithotomy positioning or in Trendelenburg without lithotomy positioning on the operating table when undergoing robotic assisted laparoscopic surgery or laparoscopic surgery.

Interventions

Patient positioning on operating table

The patients are either positioned in Trendelenburg with lithotomy positioning or in Trendelenburg without lithotomy positioning on the operating table when undergoing robotic assisted laparoscopic surgery or laparoscopic surgery.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Above 18 years.
• Robotic assisted surgery and laparoscopic surgery (urological, gynecologic, gastroenterological)
• Trendelenburg with or without lithotomy positioning on operating table.
• Planned room time > 1.5 hours.
• Speak and understand Norwegian.
• Cooperate (clinical examination).

Exclusion Criteria

• Preexisting neuropathies.
• Neurological disease.
• Impaired cognitive function.
• Drug misuse.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Signe Berit Bentsen

Professor, registered nurse, operating room nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Benedikte Bjøro

Role: CONTACT

berabj@ous-hf.no

0047 90176072

Other Identifiers

104764

Identifier Type: -

Identifier Source: org_study_id