Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track

Not Applicable

Terminated

• Conditions: Sigmoid Neoplasms
• Interventions: Procedure: laparoscopic colonic resection; Procedure: laparoscopic sigmoid resection

• Registration Number: NCT01127425
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

A blinded randomized trial. Length of hospital stay, nursing hours and recovery after laparoscopic versus open colonic resection without fast track.

Detailed Description

CONTEXT: Our preliminary experience (unpublished) indicate that less nursing hours are needed after laparoscopic colon resection without fast track. Length of hospital stay and recovery seems to be reduced as well.

OBJEKTIVE: To compare laparoscopic and open colonic resection concerning nursing hours, length of hospital stay and recovery.

DESIGN, SETTING AND PATIENTS: triple blinded study (Patient, nursing staff and data collector) including 2 x 12 patients needing sigmoid resection due to cancer. Nursing hours, length of hospital stay and recovery (postoperative pain, questionnaire, actigraph ect.)

Study Timeline

• Status Verified: 2006-06
• Study Start: 2006-07
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Last Update Submitted: 2010-06-04
• Last Update Posted: 2010-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• sigmoid resection without stoma
• sigmoid neoplasms localized 20 cm from anus
• age 40-90

Exclusion Criteria

• conversion from laparoscopic to open surgery
• stoma
• severe postoperative complications (anastomosis leak, intraabdominal abscess, reoperation, stay at intensive care unit, heart attack, pulmonary embolism)
• no informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	laparoscopic colonic resection	Intervention: Surgery: conventional (open) sigmoid resection without fast track postoperative care
1	laparoscopic sigmoid resection	Intervention: Surgery: laparoscopic sigmoid resection without fast track postoperative care

Primary Outcome Measures

Name	Time	Method
primary: Length of stay	1 year

Secondary Outcome Measures

Name	Time	Method
secondary: Nursing hours, pain and recovery	1 year

Trial Locations

Locations (1)

University Hospital of Gentofte, gastroenterologic surgery; 🇩🇰 Hellerup, Denmark