Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630767
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Enhanced Recovery After Surgery Program Versus Conventional Care for Laparoscopic Common Bile Duct Exploration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enhanced Recovery After Surgery Program Versus Conventional Care for Laparoscopic Common Bile Duct Exploration A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-10
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:
Laparoscopic common bile duct exploration LCBDE is a minimally invasive procedure to treat common bile duct stones CBDS Perioperative anxiety hunger thirst fatigue pain nausea and vomiting can influence a patients recovery after surgery and prolong the in-hospital stay Enhanced Recovery After Surgery ERAS is a modern concept that aims to improve perioperative patient care by implementing an evidence-based patient-centered team approach However few reports focused on the safety and efficacy of the ERAS program in LCBDE Therefore this paper aims to compare the outcome of the ERAS program and conventional C care for patients undergoing LCBDE
Detailed Description:
All patients undergoing surgery prefer to stay at the hospital for a shorter period and resume work as early as possible The post-operative recovery and rehabilitation are influenced by numerous surgical factors such as inadequate pain management and postoperative complications and non-surgical factors such as anxiety and stress reduced physical activity and unintended prolonged fasting due to improper scheduling
Carefully planned perioperative care is approved to shorten the rehabilitation period and accelerate the recovery by preserving preoperative organ function reducing the depth of intraoperative stress reaction and minimizing postoperative complications through many parameters such as emotional support pharmacological prophylaxis wound anesthesia PONV prophylaxis low-pressure pneumoperitoneum and restricted use of surgical drains and infusions contributing to medical and economic benefit in healthcare Two techniques are believed to improve post-operative recovery and rehabilitation the first is the minimally invasive surgery and the second is the enhanced recovery after surgery ERAS program
Laparoscopic common bile duct exploration LCBDE is one of the recent minimally invasive maneuvers to treat common bile duct stones CBDS that may be combined with laparoscopic cholecystectomy for gallbladder stones as a one-stage procedure with the advantage of minor trauma and bleeding low postoperative complication and pain quick recovery and shorter hospital stay On the contrary It has various complications due to pneumoperitoneum and positioning including changes in cardiac output and blood pressure decreased lung volumes basal atelectasis increased intrapulmonary shunting raised airway pressures acute postoperative pain and postoperative nausea and vomiting PONV
Enhanced recovery after surgery ERAS programs are a recent combination of evidenced-based perioperative care approaches that work synergistically to improve recovery after surgery The underlying mechanism of ERAS protocols is thought to be an attenuation of the peri-operative stress response and early gut function The core elements of ERAS protocols are preoperative advice optimization of diet systematic analgesic and anesthetic regimes and early mobilization It facilitates early mobilization and nutrition by controlling pain and dyspepsia therefore reducing the postoperative length of stay and allowing patients to return to their usual lifestyle as promptly as possible
Although ERAS programs have become more popular over the past decade and the Association of Surgeons of Great Britain and Ireland and ERAS society guidelines have recommended 23 guidelines for different surgical fields it remains controversial and conflicts with the traditional doctrine for surgery It therefore has been slow to be implemented so far Also no ERAS program for LCBDE was offered till now Therefore this study aimed to compare the efficacy and safety of ERAS versus conventional care in LCBDE
Carefully planned perioperative care is approved to shorten the rehabilitation period and accelerate the recovery by preserving preoperative organ function reducing the depth of intraoperative stress reaction and minimizing postoperative complications through many parameters such as emotional support pharmacological prophylaxis wound anesthesia PONV prophylaxis low-pressure pneumoperitoneum and restricted use of surgical drains and infusions contributing to medical and economic benefit in healthcare Two techniques are believed to improve post-operative recovery and rehabilitation the first is the minimally invasive surgery and the second is the enhanced recovery after surgery ERAS program
Laparoscopic common bile duct exploration LCBDE is one of the recent minimally invasive maneuvers to treat common bile duct stones CBDS that may be combined with laparoscopic cholecystectomy for gallbladder stones as a one-stage procedure with the advantage of minor trauma and bleeding low postoperative complication and pain quick recovery and shorter hospital stay On the contrary It has various complications due to pneumoperitoneum and positioning including changes in cardiac output and blood pressure decreased lung volumes basal atelectasis increased intrapulmonary shunting raised airway pressures acute postoperative pain and postoperative nausea and vomiting PONV
Enhanced recovery after surgery ERAS programs are a recent combination of evidenced-based perioperative care approaches that work synergistically to improve recovery after surgery The underlying mechanism of ERAS protocols is thought to be an attenuation of the peri-operative stress response and early gut function The core elements of ERAS protocols are preoperative advice optimization of diet systematic analgesic and anesthetic regimes and early mobilization It facilitates early mobilization and nutrition by controlling pain and dyspepsia therefore reducing the postoperative length of stay and allowing patients to return to their usual lifestyle as promptly as possible
Although ERAS programs have become more popular over the past decade and the Association of Surgeons of Great Britain and Ireland and ERAS society guidelines have recommended 23 guidelines for different surgical fields it remains controversial and conflicts with the traditional doctrine for surgery It therefore has been slow to be implemented so far Also no ERAS program for LCBDE was offered till now Therefore this study aimed to compare the efficacy and safety of ERAS versus conventional care in LCBDE
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