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

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

Detailed Description
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CONTEXT: Our preliminary experience (unpublished) indicate that less nursing hours are needed after laparoscopic colon resection without fast track.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.)

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

Conditions
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Sigmoid Neoplasms

Intervention / Treatment
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* Procedure: laparoscopic colonic resection
* Procedure: laparoscopic sigmoid resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Intervention: Surgery: laparoscopic sigmoid resection without fast track postoperative care | Procedure: laparoscopic sigmoid resection<br>* sigmoid resection by laparoscopic surgery<br>|
| Active Comparator: 2<br>Intervention: Surgery: conventional (open) sigmoid resection without fast track postoperative care | Procedure: laparoscopic colonic resection<br>* Conventional surgery compared to laparoscopic sigmoid resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary: Length of stay |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary: Nursing hours, pain and recovery |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nursing hours, length of hospital stay, reconvalescence, colorectal surgery, laparoscopic, sigmoid neoplasms