Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495853
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Prospective Phase II Study on Continuous Circumferential Reinforcement of Laparoscopic Rectal Anastomosis to Prevent Complications
Sponsor:
ZHI-ZHONG PAN
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Prospective Phase II Clinical Study on Continuous Circumferential Reinforcement of the Anastomotic Site With Laparoscopic Rectal Anastomosis to Prevent Complications
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Anastomotic leakage AL is one of the most severe complications following laparoscopic rectal cancer surgery According to the International Study Group of Rectal Cancer ISREC AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomosis leading to a communication between the intra- and extraluminal compartments including defects of the suture or staple lines of the neorectal reservoir AL is classified into three grades based on clinical severity Grade A identified only radiologically without clinical symptoms Grade B presenting with localized or atypical peritonitis requiring antibiotics and local drainage but not surgery and Grade C causing severe peritonitis systemic toxicity symptoms requiring urgent surgical intervention and potentially leading to life-threatening situations
AL can prolong hospitalization necessitate reoperation delay chemotherapy increase local recurrence rates and adversely affect survival and quality of life Emergency surgical management of AL often requires meticulous peritoneal lavage and ileostomy aiming for subsequent anastomotic healing or future digestive tract reconstruction However some patients face significant challenges due to postoperative adhesions and persistent anastomotic defects despite prolonged lavage
Identified risk factors for AL after rectal cancer surgery include male gender advanced age hypertension diabetes smoking and advanced TNM staging III-IV Additionally preoperative chemoradiotherapy-induced bowel edema and fibrosis bowel obstruction and long-term malnutrition resulting in hypoproteinemia are significant contributors Mechanical reinforcement of anastomoses using sutures or absorbable barbed sutures has been shown to significantly reduce AL rates in previous studies
This single-center prospective phase II clinical trial aims to evaluate the efficacy and safety of continuous circumferential reinforcement using absorbable barbed sutures in laparoscopic rectal anastomosis to prevent AL We will compare the incidence of AL and other postoperative complications between patients undergoing reinforced anastomosis and a control group receiving standard laparoscopic rectal anastomosis
AL can prolong hospitalization necessitate reoperation delay chemotherapy increase local recurrence rates and adversely affect survival and quality of life Emergency surgical management of AL often requires meticulous peritoneal lavage and ileostomy aiming for subsequent anastomotic healing or future digestive tract reconstruction However some patients face significant challenges due to postoperative adhesions and persistent anastomotic defects despite prolonged lavage
Identified risk factors for AL after rectal cancer surgery include male gender advanced age hypertension diabetes smoking and advanced TNM staging III-IV Additionally preoperative chemoradiotherapy-induced bowel edema and fibrosis bowel obstruction and long-term malnutrition resulting in hypoproteinemia are significant contributors Mechanical reinforcement of anastomoses using sutures or absorbable barbed sutures has been shown to significantly reduce AL rates in previous studies
This single-center prospective phase II clinical trial aims to evaluate the efficacy and safety of continuous circumferential reinforcement using absorbable barbed sutures in laparoscopic rectal anastomosis to prevent AL We will compare the incidence of AL and other postoperative complications between patients undergoing reinforced anastomosis and a control group receiving standard laparoscopic rectal anastomosis
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