Sigmoid NeoplasmsNCT01127425
Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track
A study testing laparoscopic colonic resection and laparoscopic sigmoid resection in people with Sigmoid Neoplasms, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
A blinded randomized trial. Length of hospital stay, nursing hours and recovery after laparoscopic versus open colonic resection without fast track. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Sigmoid Neoplasms
- What is being tested?
- laparoscopic colonic resection and laparoscopic sigmoid resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sigmoid resection without stoma
- sigmoid neoplasms localized 20 cm from anus
- age 40-90
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital of Gentofte, gastroenterologic surgery
Hellerup, 2900
About this study
A blinded randomized trial. Length of hospital stay, nursing hours and recovery after laparoscopic versus open colonic resection without fast track.
Read the 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CONTEXT: Our preliminary experience (unpublished) indicate that less nursing hours are needed after laparoscopic colon resection without fast track.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.)
- Conditions
- Sigmoid Neoplasms
- Being tested
- laparoscopic colonic resection, laparoscopic sigmoid resection
- Keywords
- nursing hours, length of hospital stay, reconvalescence, colorectal surgery, laparoscopic, sigmoid neoplasms
- Medical subject headings
- Sigmoid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic colonic resectionProcedure or surgery
Conventional surgery compared to laparoscopic sigmoid resection
laparoscopic sigmoid resectionProcedure or surgery
sigmoid resection by laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Intervention: Surgery: laparoscopic sigmoid resection without fast track postoperative care Receives: Procedure: laparoscopic sigmoid resection |
| 2 | Active comparator | Intervention: Surgery: conventional (open) sigmoid resection without fast track postoperative care Receives: Procedure: laparoscopic colonic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary: Length of stay
Measured: 1 year
Secondary outcomes (1)
secondary: Nursing hours, pain and recovery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startJul 2006
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Due to reorganisation in the hospital structure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sigmoid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Britta Kaltoft, doctor, Principal investigator, University of Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127425
- Sponsor's protocol ID
- KA-20060067
- Status last verified
- Jun 2006
- First submitted
- 17 Feb 2010
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track
- ClinicalTrials.gov ID
- NCT01127425
- Acronym / sponsor ID
- KA-20060067
- Conditions
- Sigmoid Neoplasms
- Keywords
- nursing hours, length of hospital stay, reconvalescence, colorectal surgery, laparoscopic, sigmoid neoplasms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to reorganisation in the hospital structure
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: laparoscopic sigmoid resectionIntervention: Surgery: laparoscopic sigmoid resection without fast track postoperative care |
| 2 | Active comparator | Procedure: laparoscopic colonic resectionIntervention: Surgery: conventional (open) sigmoid resection without fast track postoperative care |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- sigmoid resection without stoma
- sigmoid neoplasms localized 20 cm from anus
- age 40-90
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic colonic resectionConventional surgery compared to laparoscopic sigmoid resection | Procedure or surgery | 2 |
| laparoscopic sigmoid resectionsigmoid resection by laparoscopic surgery | Procedure or surgery | 1 |
Primary outcome
primary: Length of stay
Time frame: 1 year
1 secondary outcome
secondary: Nursing hours, pain and recovery
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Due to reorganisation in the hospital structure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2010.
Related trials for Sigmoid Neoplasms
Recruiting
Comparison of Safety and Efficacy of Detaenial Sigmoid Neobladder and Ileal Neobladder
Bladder Cancer, Urinary Diversion
Recruiting
Comparison Capsule Sparing Cystectomy and Radical Cystoprostatectomy in Men With Bladder Cancer
Bladder Cancer
RecruitingObservational study
The Supraspinal Control of Lower Urinary Tract Function in Patients With Orthotopic Sigmoid Neobladder.
Orthotopic Neobladder
Enrolling by invitation
Disposable Intestinal Isolation and Protection Device for Patients With Rectal and Lower Sigmoid Colon Tumors Undergoing Laparoscopic AR/LAR Surgery
Disposable Intestinal Isolation and Protection Device
Recruiting
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
Colorectal Anastomosis, Left-sided Colon Resection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britta Kaltoft, doctor principal investigator
University of Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic colonic resection and laparoscopic sigmoid resection in people with Sigmoid Neoplasms, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to reorganisation in the hospital structure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary: Length of stay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2010.