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

NCT ID: NCT01720966

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-10-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Liver resection

Intervention Type: PROCEDURE

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.

Liver resection

Intervention Type: PROCEDURE

Liver resection performed for metastatic disease from colorectal carcinoma

Interventions

Liver resection

Liver resection performed for metastatic disease from colorectal carcinoma

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry P van Goor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

Gelre Ziekenhuis

Apeldoorn, , Netherlands

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

Maastricht University Medical Center

Maastricht, , Netherlands

Daniel de hoed kliniek

Rotterdam, , Netherlands

Maxima Medisch Centrum

Veldhoven, , Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 23013804 (View on PubMed)

Other Identifiers

RU-RTB-0004

Identifier Type: -

Identifier Source: org_study_id