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

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 Overview

• Status: Completed
• Conditions: Adhesions
• Intervention / Treatment: Procedure: Liver resection

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Netherlands
  • Apeldoorn, Netherlands
    • Gelre Ziekenhuis
  • Ede, Netherlands
    • Ziekenhuis Gelderse Vallei
  • Maastricht, Netherlands
    • Maastricht University Medical Center
  • Rotterdam, Netherlands
    • Daniel de hoed kliniek
  • Veldhoven, Netherlands
    • Máxima Medisch Centrum
  • Gelderland
    • Nijmegen, Gelderland, Netherlands
      • Radboud University Nijmegen Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	peroperative (1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adhesions	Total incidence of adhesions	peroperative (1 day)
Extent of adhesions	Extent of adhesions	peroperative (1 day)
Adhesion Score	Adhesion score according to Zühlke	peroperative (1 day)
Adhesiolysis	need to perform adhesiolysis	peroperative (1 day)
Duration of adhesiolysis	Duration of adhesiolysis in minutes	peroperative (1 day)
Inadvertent bowel injury	Inadvertent bowel injury made during operation	peroperative (1 day)
Postoperative mobidity	Incidence of predetermined postoperative complications: mortality; incisional wound infection; abdominal sepsis; pneumonia; urinary tract infection	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Small bowel obstruction in history	Patient has episode of small bowel obstruction in medical history	in history (up to 5 years preceeding second operation)

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Harry P van Goor, MD, PhD, Radboud University Medical Center

Publications and helpful links

General Publications

• ten Broek RP, Strik C, Issa Y, Bleichrodt RP, van Goor H. Adhesiolysis-related morbidity in abdominal surgery. Ann Surg. 2013 Jul;258(1):98-106. doi: 10.1097/SLA.0b013e31826f4969.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: November 1, 2012
• First Posted (Estimate): November 2, 2012

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: laparotomy; laparoscopy; Adhesions; liver resection; colorectal malignancy
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Neoplasms; Tissue Adhesions
• Other Study ID Numbers: RU-RTB-0004