Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270745
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-14
Brief Title:
ICG Anastomotic Control in Digestive System Surgery
Sponsor:
Shandong Linglong Yingcheng Hospital
Organization:
Shandong Linglong Yingcheng Hospital
Study Overview
Official Title:
ICG Anastomotic Control in Digestive System Surgery
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital Shandong China The purpose of this study was to investigate the effect of indocyanine green ICG on patients undergoing digestive system surgery subtotal gastrectomy partial hepatectomy transverse colectomy left colectomy including sigmoid resection and splenic colic resection of anastomotic leakage AL Secondary objectives were to detect and study the impact of various risk factors on AL and on morbidity and surgical performance within 30 days of surgery
Detailed Description:
This was a parallel single-center retrospective cohort study observing a series of consecutive patients who underwent colorectal surgery at our institution between January 1 2018 and December 31 2023
The primary endpoint of the study is AL at 30 days and the secondary endpoint is postoperative morbidity of Clavien-Dindo score III within 30 days after surgery including readmission and redo surgery lymph node disease in patients with neoplastic disease Harvest surgical site infection laparoscopic surgery rate and protected stoma rate
According to the American Joint Committee on Cancer AJJC 8th edition gender body mass index smoking diabetes cardiovascular disease and tumor stage will be considered confounding factors in the development of AL
A patient electronic database will be collected from medical records extracted from surgical logs and each digital medical record will be scanned to include perioperative outcomes and post-operative follow-up for 30 days after surgery final readmission to the emergency room or any other department based on The following inclusion criteria performed in the specialist ward of our local health institution elective surgery left colon segmental surgery splenic colic resection transverse colic resection and left hemicolectomy defined as left hemicolectomy low Mesenteric artery ligation and sigmoid resection regardless of benign or malignant pathology minimum 30 days of postoperative follow-up available from medical documentation primary colostomy or colorectal anastomosis with or without prophylactic ostomy and age of adulthood
Exclusion criteria were distal colostomy without anastomosis after removal step extended transverse right hemicolectomy left hemicolectomy with high vascular ligation resection of associated bowel or other viscera ie tumor infiltration previous colic Surgery synchronous tumors failure to report vessel ligation in surgery form details lack of medical record reporting of primary outcome stage IV cancer American Society Of Anestheasiologists ASA IV under 18 years of age and emergencies
Reconstruction times vary with different anastomoses colostomy or colorectal techniques staplers or hand suturing and connections side to side side to end end to side or end to end
Since 2018 our institute has been using ICG fluorescence laparoscopy using a near-infrared NIR light source and a special oscilloscope and camera equipped with a xenon lamp ICG is available as a sterile water-soluble lyophilized powder Diagnostic Green GmbH ICGICG fluorescence laparoscopy is routinely used in daily practice following the following protocol after specimen resection and before anastomosis both colonic stumps or the colon and rectal stumps are examined with 5 cc of ICG 25 mg diluted in 10 cc of sterile aqueous solution
Statistical analysis and sample size
Quantitative variables will be described by mean standard deviation or median and IQR and qualitative variables will be described by absolute frequency and percentage frequency All continuous variables will be checked for normality Comparisons of covariates will be performed using the Pearson X2 test or Fishers exact test for categorical variables and the t test or Mann Whitney test for continuous variables Univariate analysis will be performed using logistic regression to examine the association of each predictor variable with anastomotic leak events Next variables with p01 were considered for inclusion in the multivariable regression model For each risk factor the odds ratio is shown along with the associated confidence interval All analyzes will be performed using spss version 270 statistical software with two-sided significance tests and a 5 significance level
The primary endpoint of the study is AL at 30 days and the secondary endpoint is postoperative morbidity of Clavien-Dindo score III within 30 days after surgery including readmission and redo surgery lymph node disease in patients with neoplastic disease Harvest surgical site infection laparoscopic surgery rate and protected stoma rate
According to the American Joint Committee on Cancer AJJC 8th edition gender body mass index smoking diabetes cardiovascular disease and tumor stage will be considered confounding factors in the development of AL
A patient electronic database will be collected from medical records extracted from surgical logs and each digital medical record will be scanned to include perioperative outcomes and post-operative follow-up for 30 days after surgery final readmission to the emergency room or any other department based on The following inclusion criteria performed in the specialist ward of our local health institution elective surgery left colon segmental surgery splenic colic resection transverse colic resection and left hemicolectomy defined as left hemicolectomy low Mesenteric artery ligation and sigmoid resection regardless of benign or malignant pathology minimum 30 days of postoperative follow-up available from medical documentation primary colostomy or colorectal anastomosis with or without prophylactic ostomy and age of adulthood
Exclusion criteria were distal colostomy without anastomosis after removal step extended transverse right hemicolectomy left hemicolectomy with high vascular ligation resection of associated bowel or other viscera ie tumor infiltration previous colic Surgery synchronous tumors failure to report vessel ligation in surgery form details lack of medical record reporting of primary outcome stage IV cancer American Society Of Anestheasiologists ASA IV under 18 years of age and emergencies
Reconstruction times vary with different anastomoses colostomy or colorectal techniques staplers or hand suturing and connections side to side side to end end to side or end to end
Since 2018 our institute has been using ICG fluorescence laparoscopy using a near-infrared NIR light source and a special oscilloscope and camera equipped with a xenon lamp ICG is available as a sterile water-soluble lyophilized powder Diagnostic Green GmbH ICGICG fluorescence laparoscopy is routinely used in daily practice following the following protocol after specimen resection and before anastomosis both colonic stumps or the colon and rectal stumps are examined with 5 cc of ICG 25 mg diluted in 10 cc of sterile aqueous solution
Statistical analysis and sample size
Quantitative variables will be described by mean standard deviation or median and IQR and qualitative variables will be described by absolute frequency and percentage frequency All continuous variables will be checked for normality Comparisons of covariates will be performed using the Pearson X2 test or Fishers exact test for categorical variables and the t test or Mann Whitney test for continuous variables Univariate analysis will be performed using logistic regression to examine the association of each predictor variable with anastomotic leak events Next variables with p01 were considered for inclusion in the multivariable regression model For each risk factor the odds ratio is shown along with the associated confidence interval All analyzes will be performed using spss version 270 statistical software with two-sided significance tests and a 5 significance level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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