Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Surgical Site Infection |
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). |
until 30 days + 10 days after surgery |
|
Secondary |
Development of Wound Dehiscence |
Incidence of wound dehiscence (skin) at different postoperative examinations |
until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively |
|
Secondary |
Reoperation Rate |
Incidence of reoperation rate at different postoperative times |
until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively |
|
Secondary |
Mortality Rate |
Incidence of mortality rate at different postoperative times |
until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively |
|
Secondary |
Postoperative Complications during the postoperative Course |
Rates of postoperative complications such as bleeding, tissue reaction, abscess, perforation, bile leaks, biliary peritonitis, ileus, stenosis, fistula at different postoperative points in time |
until discharge (ca. 10 days postop), 30 days +10 days, 1 year ±2 months postoperatively |
|
Secondary |
Suture Removal due to Wound Problems during the postoperative Course |
Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) at different defined postoperative points in time |
until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively |
|
Secondary |
Length of hospital stay |
Defined as the time period from day of operation until day of discharge (efficacy parameter). |
until discharge (ca. 10 days postop) |
|
Secondary |
Postoperative Surgical Site Infections |
Incidence of postoperative surgical site infections |
1 year ±2 months post-op |
|
Secondary |
Rate of Conversion to open surgery |
Number of interventions where operation technique has to be converted to open surgery intraoperatively |
intraoperatively |
|
Secondary |
Time to return to work |
Defined as the duration (days) from day of surgery until the day when the patient was able to work. Employment status of the patient will also be reported. |
up to 1 year ±2 months |
|
Secondary |
Course of Pain: Visual Analogue Scale (VAS) |
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. |
preoperatively, at day of discharge (ca. 10 days postop), at 30 days +10 days and 1 year ±2 months postoperatively |
|
Secondary |
Course of Cosmetic result |
Overall patient and observer satisfaction with the scar using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome in six categories (Pain, Itching, Color of scar, Stiffness of scar, thickness and irregularity of scar) on a 1 to 10 points scale each. The physician will use the Observer component, rating vascularization, pigmentation, thickness, relief and pliability of the scar on a 1 to 10 points scale each. The categories are added to a total POSAS score of 11 (minimum) to 110 points (maximum) |
30 days +10 days, 1 year ±2 months postoperatively |
|
Secondary |
Course of Overall patient and observer satisfaction with the scar: Patient and Observer Scar Assessment Scale (POSAS) |
Overall patient and observer satisfaction with the scar using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome in six categories (Pain, Itching, Color of scar, Stiffness of scar, thickness and irregularity of scar) on a 1 to 10 points scale each. The physician will use the Observer component, rating vascularization, pigmentation, thickness, relief and pliability of the scar on a 1 to 10 points scale each. The categories are added to a total POSAS score of 11 (minimum) to 110 points (maximum) |
30 days +10 day, 1 year ±2 months postoperatively |
|
Secondary |
Comparison of wound appearance |
Photographic documentation of the wounds for assessment |
discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively |
|
Secondary |
Comparison of handling parameters of the suture materials |
Comparison of the handling features of the suture materials in eight different categories (ease of passage of the suture, first throw knot holding, knot tie down smoothness, knot security, surgical hand, memory effect, lack of frying and the overall handling) by rating each category on a 5 point scale (excellent, very good, good, satisfied, poor); no overall score is calculated, the categories are compared separately |
intraoperatively |
|
Secondary |
Course of Health Status |
EQ-5D is a standardised 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 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" |
30 days +10 days after surgery, 1 year ±2 months after surgery |
|
Secondary |
Hernia Rate / Umbilical Hernia Rate |
Hernia rate including umbilical hernia postoperatively verified by ultra-sound examination compared at different postoperative points in time |
until discharge (ca. 10 days postop), 30 days +10 days, 1 year ±2 months postoperatively |
|
Secondary |
Costs (economics) |
Assessment of costs will be calculated on postoperative complication (SSI) in both suture groups (efficient parameter). |
1 year ±2 months |
|