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The GASTROMO study has been stopped early before enrolling its first patient because the results of our primary endpoint would have been inconsistent. The variability of the leakage rate between all anastomosis included in the study was overly high.
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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monoplus® | Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of anastomosis leakage rate at different timepoints in postoperative course | The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery | until 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of dehiscence rate of the suture line at different timepoints in postoperative course | Comparison of the dehiscence rate of the suture line at different postoperative examinations | at discharge (approximately 10 days after surgery), 1 month and 6 months after surgery. |
| Comparison of the Peritonitis rate at different timepoints in postoperative course |
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Inclusion criteria
Exclusion criteria
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Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for ananastomosis.
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| Name | Affiliation | Role |
|---|---|---|
| Wenceslao Vasquez Jimenez, Dr. | Hospital General Universitario Gregorio Marañon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Parc Taulí Sabadell | Sabadell | Catalonia | 08208 | Spain | ||
| Servicio de Cirugía General y Digestiva, Sección cirugía |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D013274 | Stomach Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Comparison of the Peritonitis rate of the suture line at different postoperative examinations |
| at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery |
| Comparison of the Surgical Site infection rate at different timepoints in postoperative course | 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. | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery |
| Comparison of bleeding at different timepoints in postoperative course | Comparison of postoperative Bleeding rate at different postoperative examinations | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery |
| Comparison of Abscess at different timepoints in postoperative course | Comparison of postoperative Abscess rate at different postoperative examinations | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery |
| Comparison of Postoperative Fistula at different timepoints in postoperative course | Comparison of postoperative Fistula rate at different postoperative examinations | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery |
| Comparison of Postoperative Perforation at different timepoints in postoperative course | Comparison of postoperative Perforation rate at different postoperative examinations | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery |
| Comparison of Postoperative Obstipation at different timepoints in postoperative course | Comparison of postoperative Obstipation rate at different postoperative examinations | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery |
| Comparison of Postoperative Stenosis at different timepoints in postoperative course | Comparison of postoperative Stenosis rate at different postoperative examinations | 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 timepoints in postoperative course | Comparison of Reoperation rate due to an anastomosis leakage at different postoperative examinations | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery |
| Comparison of Mortality rate at different timepoints in postoperative course | Comparison of postoperative Mortality rate at different postoperative examinations | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery |
| Comparison of Stoma rate at different timepoints in postoperative course | Comparison of postoperative Stoma rate at different postoperative examinations | at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery |
| Length of the overall postoperative hospital stay | Number of days between date of surgery and date of discharge | until discharge (approximately 10 days postoperative) |
| Length of the postoperative stay in intensive care unit | Number of days the patient has to stay in the intensive care unit after the intervention | until discharge (approximately 10 days postoperative) |
| Duration to perform the anastomosis | Time in Minutes the surgeon needs to perform the anastomosis | intraoperatively |
| Course of Health Status | 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" | until 6 months postoperative |
| Satisfaction of the patient with the 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. | at discharge (approximately 10 days postoperative), 1 month, and 6 months after surgery |
| Assessment of suture material handling parameters | 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). | intraoperatively |
| Madrid |
| 28007 |
| Spain |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009371 | Neoplasms by Site |
| D013272 | Stomach Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |