Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06270745 |
| Other study ID # |
sdycllyy001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Shandong Linglong Yingcheng Hospital |
| Contact |
Xuan Qiu, MD |
| Phone |
8618354280081 |
| Email |
qiuxuan100[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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 Fisher's 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 p<0.1 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 27.0
statistical software with two-sided significance tests and a 5% significance level.
