Colorectal Cancer, Complications of Surgical Procedures, Diverticula, Gastric Cancer, Gastrointestinal Stromal Tumor, Inflammatory Bowel Disease, Surgical Site Infection
Conditions
Keywords
skin sealant, laparoscopic surgery, surgical site infection, wound healing
Brief summary
The purpose of this study is to evaluate the short-term effect of sealant-assisted skin closure in prevention of surgical site infection after laparoscopic surgery.
Detailed description
* Study design: A prospective cohort study * Populations: Patients who have confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor (GIST), inflammatory bowel disease and diverticula decide to receive laparoscopic surgery. * Surgical techniques: laparoscopic operations should be successfully performed with a 3-4 cm minimal incision left for sample retrieval. In all, about five trocar-associated mini incisions and a sample-retrieval incision would be left prior to skin closure. * Skin closure: A quick skin sealant would be applied to achieve a seal, without any suture made under the skin. * Postoperative treatment: An enhanced recovery after surgery (ERAS) bundles would be applied for enrolled subjects. As for wound management, additional wound cares are not required. Patients can take shower at postoperative day 3 (POD3). * Primary endpoint: The primary study endpoint is freedom from surgical site infection (SSI) within 30 days. The incidence of surgical site infection with the first 30 days after surgery would be explored.
Interventions
PROCEDURELaparoscopic surgery
Various laparoscopic operations are performed for participants. Once all surgical procedures are successfully applied, surgical wounds which are associated with laparoscopic surgery would be sealed by a quick sealant. In all, the following surgical wounds would be left: * 4-5 trocar-produced incisions (5/10mm, minor incision) * 1 sample-retrieval incision (4-5cm, small incision)
DEVICESkin sealant
After surgery, a quick skin sealant is applied in two layers of each wound to achieve skin closure. The sealant would be smeared twice on the wound area with 30 seconds of dry time required to form a firm seal.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The informed consent has been obtained from the patient. * With confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor, inflammatory bowel disease and diverticula. * Endurable laparoscopic surgery without conversion. * With moderate/good ECOG health rating (PS): 0-1 score.
Exclusion criteria
* Pregnant woman or lactating woman. * With confirmed distant metastasis in liver, lung, bones, or other organs. * Intolerable laparoscopic operation or converted to open surgery. * With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. * With bad compliance or contraindication to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| freedom from surgical site infection | within the first 30 days after laparoscopic surgery | The study endpoint should be freedom from superficial surgical site infection (SSI) or deep SSI as defined by the Centers of Disease Control and Prevention National Nosocomial Infection Surveillance criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | an expected average of 4 weeks | All participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Pain Scores on the Visual Analog Scale | within the first 30 days after laparoscopic surgery | Postoperative pain would be recorded. |
Countries
China
Contacts
Primary ContactYujie Yuan, MD
Outcome results
None listed