Right-sided Colon Tumor, Laparoscopic Versus Open Surgery, in an ERAS Protocol

Colon Tumor Clinical Trial

Official title:

Right-sided Colon Tumor, Laparoscopic and Open Surgery, in an ERAS Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831245
• Other study ID #: 2012/2105-31/2
• Status: Completed
• Phase: N/A
• First received: February 25, 2013
• Last updated: February 19, 2015
• Start date: January 2011
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Register study. Patients who had been operated for right-sided colon tumor or benign adenoids between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an ERAS (Enhanced Recovery After Surgery) protocol.

Hypothesis:

Operation of right-sided colon tumor and large benign adenoids, a better selection of patients for open or laparoscopic surgery can improve short term results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• right-sided colon tumor or large benign adenoids

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Tumor
• Colonic Neoplasms

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro
Sweden	Danderyds Hospital	Stockholm
Sweden	Ersta Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Danderyd Hospital, Ersta Hospital, Sweden, University Hospital Orebro

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immobilizing patient after surgery	After laparoscopic versus open surgery	4 -10 hours after surgery	No
Other	Leakage of anastomosis	Compare laparoscopic versus open surgery	0 - 30 days after surgery	No
Primary	Pathological Anatomic diagnosis (PAD) on a tumor biopsy	After PAD result, malign or benign tumor, type of malign tumor,tumor growth, stage, lymphatic recharge.; Right selection of patients to laparoscopic versus open surgery in relation to PAD result?	day of surgery	No
Secondary	Length of hospital stay, days	Compare laparoscopic versus open surgery	30 days after surgery	No
Secondary	C - reactive protein	Inflammation answer laparoscopic versus open surgery	1-7 days after surgery	No