Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492193
Status:
COMPLETED
Last Update Posted:
2014-12-15
First Post:
2007-06-25
Brief Title:
Early Post-Op Recovery After Partial Large Bowel Resection
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
A Prospective Observational Multi-center Study Assessing Early Post-Operative Recovery Following Laparoscopic Partial Large Bowel Resection
Status:
COMPLETED
Status Verified Date:
2008-08
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:
The purpose of this trial is to gather information on the postoperative recovery time and hospital length of stay experienced by patients having laparoscopic surgeries This trial will also collect data on daily surgical pain and pain medication and how it relates to recovery after surgery In addition the investigators will collect data on the use of pain medication and laxatives in patients following laparoscopic large bowel resection
Detailed Description:
Laparoscopic surgery was initially performed by surgeons in France in 1987 and was introduced in the United States in 1988 This minimally invasive procedure was performed for cholecystectomy and is now the standard of care in the treatment of gallbladder disease Recent advances in laparoscopic surgery and its success in cholecystectomy have permitted the procedure to be used for treating a variety of diseases and for diagnosing and staging
Minimally invasive laparoscopic surgery has advantages over conventional open surgery including smaller incisions earlier gastrointestinal GI recovery shorter hospital stays less pain and fewer complications In recent years evidence is accumulating for some operations that laparoscopic procedures produce outcomes that are comparable to those produced by routine open surgery and may actually surpass others
Whereas laparoscopic surgery has been successful and well accepted for various abdominal and pelvic surgeries its use in the area of colorectal surgery has progressed at a slower rate There are challenges impacting the wider use of laparoscopic bowel resection LBR These include the technical difficulty associated with the size of the colon the need for complete immobilization of the bowel and the need for a watertight non-leaking anastomosis In addition the equipment is expensive and surgeons require specialized training
Results from studies in colon cancer now indicate that LBR reduces perioperative morbidity and decreases hospital stay with comparable cancer-related survival as compared to open colectomy The use of LBR in short-term outcomes is increasing because clinical trial data have demonstrated superiority of LBR particularly in short-term outcomes over conventional open surgery
Gastrointestinal recovery and related patient outcomes during the early postoperative period following open segmental colon resection have been extensively evaluated in previous randomized controlled multicenter trials Current data in laparoscopic colectomy have been collected from retrospective single center clinical trials which lacked standardized definitions and endpoints Therefore this prospective multicenter study in LBR is being undertaken to determine how this surgical technique impacts GI recovery and related outcomes relative to the open laparotomy
The primary objective of this study is to assess the clinical course of gastrointestinal GI recovery and hospital length of stay in subjects undergoing laparoscopic partial large bowel resection The secondary objective is to assess the immediate post discharge clinical course of subjects undergoing laparoscopic bowel resection with respect to opioid-induced GI effects daily surgical pain opioid consumption and laxative use
Minimally invasive laparoscopic surgery has advantages over conventional open surgery including smaller incisions earlier gastrointestinal GI recovery shorter hospital stays less pain and fewer complications In recent years evidence is accumulating for some operations that laparoscopic procedures produce outcomes that are comparable to those produced by routine open surgery and may actually surpass others
Whereas laparoscopic surgery has been successful and well accepted for various abdominal and pelvic surgeries its use in the area of colorectal surgery has progressed at a slower rate There are challenges impacting the wider use of laparoscopic bowel resection LBR These include the technical difficulty associated with the size of the colon the need for complete immobilization of the bowel and the need for a watertight non-leaking anastomosis In addition the equipment is expensive and surgeons require specialized training
Results from studies in colon cancer now indicate that LBR reduces perioperative morbidity and decreases hospital stay with comparable cancer-related survival as compared to open colectomy The use of LBR in short-term outcomes is increasing because clinical trial data have demonstrated superiority of LBR particularly in short-term outcomes over conventional open surgery
Gastrointestinal recovery and related patient outcomes during the early postoperative period following open segmental colon resection have been extensively evaluated in previous randomized controlled multicenter trials Current data in laparoscopic colectomy have been collected from retrospective single center clinical trials which lacked standardized definitions and endpoints Therefore this prospective multicenter study in LBR is being undertaken to determine how this surgical technique impacts GI recovery and related outcomes relative to the open laparotomy
The primary objective of this study is to assess the clinical course of gastrointestinal GI recovery and hospital length of stay in subjects undergoing laparoscopic partial large bowel resection The secondary objective is to assess the immediate post discharge clinical course of subjects undergoing laparoscopic bowel resection with respect to opioid-induced GI effects daily surgical pain opioid consumption and laxative use
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14CL401 | OTHER | Adolor Corporation | None |