Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection
Condition: Adhesions
MeSH terms: Neoplasms; Tissue Adhesions
Study type: Observational

Summary: 
      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.
    


Intervention name(s): Liver resection
Intervention type(s): Procedure
Intervention description(s): Liver resection performed for metastatic disease from colorectal carcinoma
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutive patients undergoing laparotomy or laparoscopy for intended liver resection
        or radio frequency ablation for colorectal metastases in the before mentioned centers will
        be assessed for eligibility. The planned number of patients will be recruited in
        approximately 1 year.
      
Keywords: Adhesions; laparoscopy; laparotomy; liver resection; colorectal malignancy