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

NCT01720966 | Completed

• 1 other identifier: RU-RTB-0004
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Adhesions

Keywords

Adhesions; laparoscopy; laparotomy; liver resection; colorectal malignancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of adhesions

  peroperative (1 day)

• Extent of adhesions

  peroperative (1 day)

• Adhesion Score

  peroperative (1 day)

• Adhesiolysis

  peroperative (1 day)

• Duration of adhesiolysis

  peroperative (1 day)

Other Outcomes (1)

• Small bowel obstruction in history

  in history (up to 5 years preceeding second operation)

Study Arms (2)

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

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

Interventions

Liver resection PROCEDURE

Liver resection performed for metastatic disease from colorectal carcinoma

Laparoscopy; Laparotomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (6)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

Location

Gelre Ziekenhuis

Apeldoorn, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Daniel de hoed kliniek

Rotterdam, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, Netherlands

Location

Related 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.

  PMID: 23013804 BACKGROUND

MeSH Terms

Conditions

Tissue Adhesions

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Harry P van Goor, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 2, 2012
• Study Start: January 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

NL (6)