An observational study in Adhesions, sponsored by Radboud University Medical Center. Completed at 6 sites in Netherlands. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2015-11-10.
Sponsored by Radboud University Medical Center · Observational
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:
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
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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.
Exclusion Criteria:
a history of abdominal surgery with a high risk of adhesions either before resection of the primary tumour or during the interval between resection of the primary tumour and liver resection. These high risk surgeries are:
Patients who will undergo liver resection who have a laparoscopically performed colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.
Procedure: Liver resection
Patients who will undergo liver resection who have an open colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.
Procedure: Liver resection
Liver resection performed for metastatic disease from colorectal carcinoma
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
Small bowel obstruction in history
Patient has episode of small bowel obstruction in medical history
Time frame: in history (up to 5 years preceeding second operation)
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center