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

Adhesions Clinical Trial

— ALIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720966
• Other study ID #: RU-RTB-0004
• Status: Completed
• Phase: N/A
• First received: October 24, 2012
• Last updated: November 9, 2015
• Start date: January 2013
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adhesions
• Tissue Adhesions

Intervention

Procedure:
• Liver resection
Liver resection performed for metastatic disease from colorectal carcinoma

Locations

Country	Name	City	State
Netherlands	Gelre Ziekenhuis	Apeldoorn
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland
Netherlands	Daniel de hoed kliniek	Rotterdam
Netherlands	Maxima Medisch Centrum	Veldhoven

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Small bowel obstruction in history	Patient has episode of small bowel obstruction in medical history	in history (up to 5 years preceeding second operation)	No
Primary	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)	No
Secondary	Incidence of adhesions	Total incidence of adhesions	peroperative (1 day)	No
Secondary	Extent of adhesions	Extent of adhesions	peroperative (1 day)	No
Secondary	Adhesion Score	Adhesion score according to Zühlke	peroperative (1 day)	No
Secondary	Adhesiolysis	need to perform adhesiolysis	peroperative (1 day)	No
Secondary	Duration of adhesiolysis	Duration of adhesiolysis in minutes	peroperative (1 day)	No
Secondary	Inadvertent bowel injury	Inadvertent bowel injury made during operation	peroperative (1 day)	No
Secondary	Postoperative mobidity	Incidence of predetermined postoperative complications: mortality; incisional wound infection; abdominal sepsis; pneumonia; urinary tract infection	30 days	No