Adhesion prevention after abdominal surgery K66.0 K56.0 K56.5 K91.81 K91.83
Conditions
Interventions
Group 1: Adhesion prevention during surgery is carried out using 4DryField.
Group 2: There will be no additional adhesion prevention procedure, only the standard flushing with ringer solution.
Sponsors
PlantTec Medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Open surgery, because of one of the following reasons: Intra-abdominal perforation in general, perforation of hollow organs (gall, stomach, intestine), complicated diverticulitis, intra-abdominal adhesions, intestinal fistulas, anastomotic insufficiency; additionally: compliance of the patient, written consent of the patient
Exclusion criteria
Exclusion criteria: Intolerance of substances containing starch, pregnancy, missing compliance, missing written consent of the patient, missing legal capacity, participation in different studies that could interfere with the results of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primarily, it will be examined if 4DryField® PH is capable of reducing intra-abdominal adhesions in patients, which have a prompt second look operation. This applies to patients, which have an emergency laparotomy or a laparotomy with complications and get indexed intra-operatively for a second look operation within 72 hours. Peri-operatively, the surgeon examines the degree and quality of the peritonitis (degree: how many quadrants are affected, quality: purulent, muddy, serous). Additionally, the surgeon evaluates the adhesions during the second look operation using a two-part score: 1. Adhesion strength (0=no adhesions, 1=filmy adhesions, blunt dissection, 2=strong adhesions, sharp dissection, 3=very strong adhesions, vascularised, damage hardly avoidable), 2. Adhesion extent (0=no adhesions, 1=local adhesions, area25x25cm). Scoring is documented photographically also separately for each quadrant (in ventral view). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary goals are particularly complications, which can be caused by intra-abdominal surgery, manipulations of the intestine or intra-abdominal adhesions. This includes the frequency of the occurrence of paralytic ileus, the time to restoration of gastrointestinal passage (measured as the time until the first post-operative defecation occurs), the time until transition to normal diet, the frequency of occurrence of anastomotic insufficiencies, laxative usage, as well as the identification of patients or treatment groups, which benefited from the usage of 4DryField for adhesion prevention. There are three measurement points during the patients’ hospital stay in addition to the operation itself: day 2 or 3, day 5, as well as the day of discharge. On these days the following aspects are evaluated: healing of wounds and of fasciae, time until transition to normal diet, laxative demand, level of abdominal pain (pain score from 0 to 10), as well as the rate of gastrointestinal passage disorders. Additionally, the volume and quality of the drainage are recorded on a daily basis. The next measurement point is a physical examination 8 to 14 days after discharge. Furthermore, there will be a telephone interview after 6 and 12 months. The following aspects will be evaluated each time: possible wound healing disturbances (incisional hernia), rate of necessary surgical reinterventions caused by abdominal adhesions or ileus, laxative demand, digestion disorders, level of abdominal pain, as well as the rate of gastrointestinal passage disorders. | — |
Countries
Germany
Contacts
Public ContactSebastian Holländer
Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie, Universitätsklinikum des Saarlandes
Outcome results
None listed