NCT01127425

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
Last Updated

June 7, 2010

Status Verified

June 1, 2006

Enrollment Period

2.4 years

First QC Date

February 17, 2010

Last Update Submit

June 4, 2010

Conditions

Sigmoid Neoplasms

Keywords

nursing hourslength of hospital stayreconvalescencecolorectal surgerylaparoscopicsigmoid neoplasms

Outcome Measures

Primary Outcomes (1)

  • primary: Length of stay

    1 year

Secondary Outcomes (1)

  • secondary: Nursing hours, pain and recovery

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR

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

Procedure: laparoscopic sigmoid resection

2

ACTIVE COMPARATOR

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

Procedure: laparoscopic colonic resection

Interventions

laparoscopic colonic resectionPROCEDURE

Conventional surgery compared to laparoscopic sigmoid resection

2
laparoscopic sigmoid resectionPROCEDURE

sigmoid resection by laparoscopic surgery

1

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Gentofte, gastroenterologic surgery

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Sigmoid Neoplasms

Condition Hierarchy (Ancestors)

Colonic NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesSigmoid Diseases

Study Officials

  • Britta Kaltoft, doctor

    University of Gentofte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2010

First Posted

May 20, 2010

Study Start

July 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 7, 2010

Record last verified: 2006-06

Locations

DK(1)