Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection (ALIVE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01720966
First received: October 24, 2012
Last updated: November 1, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Adhesions
Procedure: Liver resection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Incidence of adhesion to ventral abdominal wall [ Time Frame: peroperative (1 day) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of adhesions [ Time Frame: peroperative (1 day) ] [ Designated as safety issue: No ]
    Total incidence of adhesions

  • Extent of adhesions [ Time Frame: peroperative (1 day) ] [ Designated as safety issue: No ]
    Extent of adhesions

  • Adhesion Score [ Time Frame: peroperative (1 day) ] [ Designated as safety issue: No ]
    Adhesion score according to Zühlke

  • Adhesiolysis [ Time Frame: peroperative (1 day) ] [ Designated as safety issue: No ]
    need to perform adhesiolysis

  • Duration of adhesiolysis [ Time Frame: peroperative (1 day) ] [ Designated as safety issue: No ]
    Duration of adhesiolysis in minutes

  • Inadvertent bowel injury [ Time Frame: peroperative (1 day) ] [ Designated as safety issue: No ]
    Inadvertent bowel injury made during operation

  • Postoperative mobidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    Incidence of predetermined postoperative complications:

    • mortality
    • incisional wound infection
    • abdominal sepsis
    • pneumonia
    • urinary tract infection


Other Outcome Measures:
  • Small bowel obstruction in history [ Time Frame: in history (average time between 2 operations 5 years) ] [ Designated as safety issue: No ]
    Patient has episode of small bowel obstruction in medical history


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Laparoscopy
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
Liver resection performed for metastatic disease from colorectal carcinoma
Laparotomy
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • laparotomy or laparoscopy for intended liver resection or radio frequency ablation for colorectal metastases
  • laparoscopy or laparotomy for colorectal malignancy in history
  • age ≥18 years

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:

    • Colorectal surgery
    • Ovarian surgery
    • Abdominal wall surgery
  • mental incompetence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720966

Locations
Netherlands
Radboud University Nijmegen Medical Center Not yet recruiting
Nijmegen, Gelderland, Netherlands
Contact: R PG ten Broek    +31243619493    r.tenbroek@chir.umcn.nl   
Principal Investigator: M Stommel         
Sub-Investigator: R ten Broek         
Principal Investigator: H van Goor         
Sponsors and Collaborators
Radboud University
  More Information

Publications:
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01720966     History of Changes
Other Study ID Numbers: RU-RTB-0004
Study First Received: October 24, 2012
Last Updated: November 1, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Adhesions
laparoscopy
laparotomy
liver resection
colorectal malignancy

Additional relevant MeSH terms:
Tissue Adhesions
Neoplasms
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014