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

NCT ID: NCT01127425

Last Updated: 2010-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-12-31

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CONTEXT: Our preliminary experience (unpublished) indicate that less nursing hours are needed after laparoscopic colon resection without fast track.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

Conditions

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Sigmoid Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Intervention: Surgery: laparoscopic sigmoid resection without fast track postoperative care

Group Type ACTIVE_COMPARATOR

laparoscopic sigmoid resection

Intervention Type PROCEDURE

sigmoid resection by laparoscopic surgery

2

Intervention: Surgery: conventional (open) sigmoid resection without fast track postoperative care

Group Type ACTIVE_COMPARATOR

laparoscopic colonic resection

Intervention Type PROCEDURE

Conventional surgery compared to laparoscopic sigmoid resection

Interventions

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laparoscopic colonic resection

Conventional surgery compared to laparoscopic sigmoid resection

Intervention Type PROCEDURE

laparoscopic sigmoid resection

sigmoid resection by laparoscopic surgery

Intervention Type PROCEDURE

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Gentofte Hospital, Copenhagen

Principal Investigators

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Britta Kaltoft, doctor

Role: PRINCIPAL_INVESTIGATOR

University of Gentofte

Locations

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University Hospital of Gentofte, gastroenterologic surgery

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KA-20060067

Identifier Type: -

Identifier Source: org_study_id

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