Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion formation might be reduced by laparoscopic surgery, however sound evidence is lacking. Colorectal surgery would be a good clinical model to investigate adhesion formation between open and laparoscopic surgery because of the adhesion formation propensity of colorectal surgery. However, a randomized controlled study to provide direct evidence is unlikely because of large numbers of patients needed for such a trial and the difficulty to check for adhesion formation at second surgery. Therefore we investigate adhesion formation after laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases. Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic versus open surgery for colorectal malignancies during liver resection for colorectal metastases. Study design: The study is designed as a prospective observational cohort study. Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for liver metastases of a colorectal malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions. Main study parameters/endpoints: * Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site of the original incision. * Secondary endpoints are episodes of bowel obstruction between index surgery and liver surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative complications: enterotomy, seromuscular injury, inadvertent organ injury during adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is an observational study. The existence of adhesions will be assessed during laparotomy or laparoscopy for the treatment of liver metastases. The laparotomy is indicated for medical treatment and should not be enlarged solely for the assessment of adhesions nor will the operating time be influenced for this purpose. Adhesions and peroperative complications have to be scored by the operating surgeon during or directly after surgery. The postoperative complications have to be scored during the postoperative course by the doctors on the ward. These assessments do not interfere with the treatment of the patients.
Study Type
OBSERVATIONAL
Enrollment
150
Liver resection performed for metastatic disease from colorectal carcinoma
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands
Gelre Ziekenhuis
Apeldoorn, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Daniel de hoed kliniek
Rotterdam, Netherlands
Maxima Medisch Centrum
Veldhoven, Netherlands
Incidence of adhesion to ventral abdominal wall
To compare the incidence of adhesions to the ventral abdominal wall in patients undergoing laparotomy or laparoscopy for intended liver resection for colorectal metastases after open versus laparoscopic resection of the primary tumour.
Time frame: peroperative (1 day)
Incidence of adhesions
Total incidence of adhesions
Time frame: peroperative (1 day)
Extent of adhesions
Extent of adhesions
Time frame: peroperative (1 day)
Adhesion Score
Adhesion score according to Zühlke
Time frame: peroperative (1 day)
Adhesiolysis
need to perform adhesiolysis
Time frame: peroperative (1 day)
Duration of adhesiolysis
Duration of adhesiolysis in minutes
Time frame: peroperative (1 day)
Inadvertent bowel injury
Inadvertent bowel injury made during operation
Time frame: peroperative (1 day)
Postoperative mobidity
Incidence of predetermined postoperative complications: * mortality * incisional wound infection * abdominal sepsis * pneumonia * urinary tract infection
Time frame: 30 days
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