Colon Tumor, Digestive System Neoplasm, Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors, Rectum Tumor, Small Intestine Tumor, Stomach Tumor
Conditions
Keywords
tumor disease, stomach tumor, small intestine tumor, colon tumor, rectum tumor, need for anastomosis
Brief summary
The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction. This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.
Interventions
None listed
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing an elective open or laparoscopic primary tumor resection within GI tract (stomach, small intestine, large intestine , colon and rectum. * Age ≥ 18 years * ASA ≤ III * Written informed consent
Exclusion criteria
* ASA ≥IV * Emergency operations * Peritonitis * Surgical interventions in the pancreas, oesophagus * Patients with traumatic perforations * Pregnant and/or breast-feeding women * Patients who had received chemotherapy within the last 4 weeks or radiotherapy on the treated region within the last 2 weeks * Patients who were receiving immunosuppressant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of anastomosis leakage rate at different timepoints in postoperative course | until 6 months after surgery | The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Peritonitis rate at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Comparison of the Peritonitis rate of the suture line at different postoperative examinations |
| Comparison of the Surgical Site infection rate at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Incidence of postoperative surgical site infections, SSI (A1: Superficial incisional site infections and A2: Deep incisional surgical site infections) (efficacy parameter) Surgical Site Infection (SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC) at different postoperative examinations. |
| Comparison of bleeding at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Comparison of postoperative Bleeding rate at different postoperative examinations |
| Comparison of Abscess at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Comparison of postoperative Abscess rate at different postoperative examinations |
| Comparison of Postoperative Fistula at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Comparison of postoperative Fistula rate at different postoperative examinations |
| Comparison of Postoperative Perforation at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Comparison of postoperative Perforation rate at different postoperative examinations |
| Comparison of Postoperative Obstipation at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Comparison of postoperative Obstipation rate at different postoperative examinations |
| Comparison of Postoperative Stenosis at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Comparison of postoperative Stenosis rate at different postoperative examinations |
| Comparison of dehiscence rate of the suture line at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month and 6 months after surgery. | Comparison of the dehiscence rate of the suture line at different postoperative examinations |
| Comparison of Mortality rate at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Comparison of postoperative Mortality rate at different postoperative examinations |
| Comparison of Stoma rate at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Comparison of postoperative Stoma rate at different postoperative examinations |
| Length of the overall postoperative hospital stay | until discharge (approximately 10 days postoperative) | Number of days between date of surgery and date of discharge |
| Length of the postoperative stay in intensive care unit | until discharge (approximately 10 days postoperative) | Number of days the patient has to stay in the intensive care unit after the intervention |
| Duration to perform the anastomosis | intraoperatively | Time in Minutes the surgeon needs to perform the anastomosis |
| Course of Health Status | until 6 months postoperative | EQ-5D-5L is a standardized measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L is designed for self-completion by respondents and it takes only a few minutes to complete. Instructions to respondents are included in the questionnaire. EQ-5D-5L consists of 2 pages - descriptive system and the EQ visual Analogue scale (EQ-VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the respondents self rated health on a 20 cm vertical , visual analogue scale with endpoints labelled the best health you can imagine and the worst health you can imagine |
| Satisfaction of the patient with the surgery | at discharge (approximately 10 days postoperative), 1 month, and 6 months after surgery | This parameter will be noted using the Visual Analogue Scale (VAS) which state 0 at one end representing no pain and 100 at the opposite end representing maximal pain. The values are compared over postoperative period. |
| Assessment of suture material handling parameters | intraoperatively | Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, stiffness) with 5 evaluation levels (excellent, very good, good, satisfied, poor). |
| Comparison of Reoperation rate due to an anastomosis leakage at different timepoints in postoperative course | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery | Comparison of Reoperation rate due to an anastomosis leakage at different postoperative examinations |
Countries
Spain
Outcome results
None listed