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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04811833
Other study ID # AAG-O-H-2005
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 2022
Est. completion date December 2023

Study information

Verified date April 2023
Source Aesculap AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Spain Servicio de Cirugía General y Digestiva, Sección cirugía Madrid
Spain Hospital Parc Taulí Sabadell Sabadell Cataluña

Sponsors (2)

Lead Sponsor Collaborator
Aesculap AG B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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.
Secondary Comparison of the Peritonitis rate at different timepoints in postoperative course 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Length of the overall postoperative hospital stay Number of days between date of surgery and date of discharge until discharge (approximately 10 days postoperative)
Secondary 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)
Secondary Duration to perform the anastomosis Time in Minutes the surgeon needs to perform the anastomosis intraoperatively
Secondary 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
Secondary 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
Secondary 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
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