Quality of LifeNCT02627729
J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer
A study testing Linear cutter-Circular stapler and Circular stapler in people with Quality of Life and Fecal Incontinence, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
Trial summary
Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Life, Fecal Incontinence, Postoperative Complications
- What is being tested?
- Linear cutter-Circular stapler and Circular stapler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Feb 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope
Who cannot join
- refusal of the patient to participate
- pregnancy,
- previous radiation therapy,
- those have cancers other than adenocarcinoma,
- those planned to have local excision or abdominoperineal resection
About this study
Official title: J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer: Short and Long-Term Outcomes of a Prospective Randomized Trial
Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection
- Being tested
- Linear cutter-Circular stapler, Circular stapler
- Medical subject headings
- Fecal Incontinence, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear cutter-Circular staplerDevice
a 5 to 6 cm-long colonic pouch will be created with a 80 mm linear cutting-closing stapler. The anastomosis of j-pouch will be routinely strengthened with 3:0 vicryl sutures. Then, a pouch to anal anastomosis will be performed
Circular staplerDevice
a 5 to 6 cm-long colonic segment will be left at the distal part and a side-to-end anastomosis will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Linear cutter-Circular stapler J pouch | Active comparator | J pouch anal anastomosis after laparoscopic low anterior resection Receives: Device: Linear cutter-Circular stapler |
| Circular stapler Side-to-end anastomosis | Active comparator | side to end coloanal anastomosis after laparoscopic low anterior resection Receives: Device: Circular stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form 36 Quality of life Questionnaire
Measured: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
Secondary outcomes (4)
Postoperative complications
Measured: 30 days postoperatively
Functional outcome measured with Fecal Incontinence Severity Index
Measured: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
Functional outcome measured with Sexual Health Inventory
Measured: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
Functional outcome measured with Overactive Bladder validated 8 scale
Measured: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJun 2009
- Primary completionApr 2012
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nuri Okkabaz, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627729
- Sponsor's protocol ID
- DrLutfi2
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer: Short and Long-Term Outcomes of a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02627729
- Acronym / sponsor ID
- DrLutfi2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- Jun 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Dec 2015 (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.
Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linear cutter-Circular stapler J pouch | Active comparator | Device: Linear cutter-Circular staplerJ pouch anal anastomosis after laparoscopic low anterior resection |
| Circular stapler Side-to-end anastomosis | Active comparator | Device: Circular staplerside to end coloanal anastomosis after laparoscopic low anterior resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope
Key exclusion criteria (5 listed)
- refusal of the patient to participate
- pregnancy,
- previous radiation therapy,
- those have cancers other than adenocarcinoma,
- those planned to have local excision or abdominoperineal resection
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 |
|---|---|---|
| Linear cutter-Circular staplera 5 to 6 cm-long colonic pouch will be created with a 80 mm linear cutting-closing stapler. The anastomosis of j-pouch will be routinely strengthened with 3:0 vicryl sutures. Then, a pouch to anal anastomosis will be performed | Device | Linear cutter-Circular stapler J pouch |
| Circular staplera 5 to 6 cm-long colonic segment will be left at the distal part and a side-to-end anastomosis will be performed. | Device | Circular stapler Side-to-end anastomosis |
Primary outcome
Short Form 36 Quality of life Questionnaire
Time frame: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
4 secondary outcomes
Postoperative complications
Time frame: 30 days postoperatively
Functional outcome measured with Fecal Incontinence Severity Index
Time frame: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
Functional outcome measured with Sexual Health Inventory
Time frame: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
Functional outcome measured with Overactive Bladder validated 8 scale
Time frame: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Linear cutter-Circular stapler and Circular stapler in people with Quality of Life and Fecal Incontinence, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Short Form 36 Quality of life Questionnaire (time frame: Change from baseline scores at 4th, 8th and 12th months after stoma reversal). 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 11 Dec 2015.