Viewing Study NCT06578611



Ignite Creation Date: 2024-10-26 @ 3:39 PM
Last Modification Date: 2024-10-26 @ 3:39 PM
Study NCT ID: NCT06578611
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-27

Brief Title: Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion
Sponsor: None
Organization: None

Study Overview

Official Title: The Effects of Perioperative Smoking Cessation on Complications in Elderly Chinese Undergoing Spinal Fusion With Enhanced Recovery After Surgery A Prospective Cohort Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: As Chinas society ages faster the number of elderly patients undergoing spinal fusion surgery will gradually increase Since elderly patients are at higher risk of postoperative complications than younger patients minimizing complications after spinal fusion becomes a priority in postoperative rehabilitation The purpose of this prospective cohort study is to develop an enhanced recovery after surgery program including individualized perioperative smoking cessation strategies in Chinese elderly undergoing spinal fusion
Detailed Description: With the aging society elderly population in China has reached 172 million 12 in 2020 and is predicted to rise to 336 million 26 by 2050 This will be accompanied by more elderly people with degenerative spinal diseases who may become candidates for spinal surgery eg spinal fusion Compared with younger patients elderly patients are more likely to experience complications after spinal fusion eg 9 and 14 for 65 and 65 years old in lumbar fusion which may lead to adverse patient outcomes including worse functional outcomes and satisfaction and increased revision surgery

Recently enhanced recovery after surgery ERAS program for spinal fusion including the pre- intra- and post-operative care interventions has been developed Previous studies have shown that ERAS has multiple benefits for elderly undergoing spinal fusion such as reduced complications and shorter hospital stays However the preoperative smoking cessation protocols varied widely between studies eg at least 4 weeks 3 months and 2 weeks before surgery which may be due to a lack of evidence

Therefore we plan to conduct a prospective study to improve the perioperative smoking cessation strategy of ERAS and establish an evidence-derived protocol

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None