Low Rectal AdenocarcinomaNCT01396928

Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum

An observational study of Low Rectal Adenocarcinoma, run by Hospital Universitari de Bellvitge.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of the study CGD-01/2000 was to investigate wheter a transverse coloplasty pouch is able to improve functional results and quality of life after coloanal anastomosis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Rectal Adenocarcinoma
What is being tested?: Colonic reservoir
Type of treatment: Surgery or procedure
How many people: 106 participants
Where: No sites listed yet
Study dates: Nov 2000to Jul 2010
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients wiht low or middle rectal adenocarcinoma after neoadyuvant radio-chemotherapy

Who may be able to join

Low or middle rectal adenocarcinoma without involvement of the anal sphincter
Neoadjuvant chemoradiotherapy
Age older than 18 years
Wexner index of less than 5
Signed informed consent

Who cannot join

Involvement of the anal sphincter
Wexner index of 5 or more
Declined informed consent
Psychological or social problems

About this study

Official title: Prospective Randomized Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum

The aim of the study CGD-01/2000 was to investigate wheter a transverse coloplasty pouch is able to improve functional results and quality of life after coloanal anastomosis.

Conditions: Low Rectal Adenocarcinoma
Being tested: Colonic reservoir
Keywords: Low rectal adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Colonic reservoirProcedure or surgery
Type of reservoir to be performed

Study groups in NCT01396928
Study group	Role	What they receive
"J" pouch		Anastomosis coloanal wiht "j" pouch reservoir Receives: Procedure: Colonic reservoir
Transverse coloplasty pouch		Coloanal anastomosis with transverse coloplasty pouch reservoir Receives: Procedure: Colonic reservoir

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of life
Functional results and quality of life after coloanal anastomosis with colonic reservoir
Measured: five years

Secondary outcomes (1)

Morbidity and cost-effectiveness
Investigate if the new technique is more easily, quickly and cheap.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2000Jul 2010

First posted19 Jul 2011 (estimated)
Study startNov 2000
Primary completionDec 2005
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Rectal AdenocarcinomaStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01396928
Sponsor's protocol ID: CGD-01/2000
Status last verified: Nov 2000
First submitted: 18 Jul 2011
Last updated: 2 Oct 2012
Results posted: No
Data monitoring committee: No

Publications

Biondo S, Frago R, Codina Cazador A, Farres R, Olivet F, Golda T, Miguel B, Kreisler E. Long-term functional results from a randomized clinical study of transverse coloplasty compared with colon J-pouch after low anterior resection for rectal cancer. Surgery. 2013 Mar;153(3):383-92. doi: 10.1016/j.surg.2012.08.012. Epub 2012 Sep 14.
PubMed 22981362

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
SCRT + Fruquintinib + Tislelizumab + CAPOX Versus SCRT + Tislelizumab + CAPOX as Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer
Rectal Neoplasms, Rectal Cancer, Adenocarcinoma
RecruitingPhase 2
Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer
Colorectal Cancer (CRC)
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
RecruitingPhase 1
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Advanced or Metastatic Solid Tumor

All Low Rectal Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum
ClinicalTrials.gov ID: NCT01396928
Acronym / sponsor ID: CGD-01/2000
Conditions: Low Rectal Adenocarcinoma
Keywords: Low rectal adenocarcinoma
Study type: Observational
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Hospital Universitari de BellvitgeUniversity, hospital or other
Study start: Nov 2000
Primary completion: Dec 2005 (actual)
Study completion: Jul 2010 (actual)
First posted: 19 Jul 2011 (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.

The aim of the study CGD-01/2000 was to investigate wheter a transverse coloplasty pouch is able to improve functional results and quality of life after coloanal anastomosis.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
"J" pouch	–	Procedure: Colonic reservoirAnastomosis coloanal wiht "j" pouch reservoir
Transverse coloplasty pouch	–	Procedure: Colonic reservoirColoanal anastomosis with transverse coloplasty pouch reservoir

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients wiht low or middle rectal adenocarcinoma after neoadyuvant radio-chemotherapy

Key inclusion criteria (5 listed)

Low or middle rectal adenocarcinoma without involvement of the anal sphincter
Neoadjuvant chemoradiotherapy
Age older than 18 years
Wexner index of less than 5
Signed informed consent

Key exclusion criteria (4 listed)

Involvement of the anal sphincter
Wexner index of 5 or more
Declined informed consent
Psychological or social problems

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
Colonic reservoirType of reservoir to be performed	Procedure or surgery	"J" pouch, Transverse coloplasty pouch

Primary outcome

Quality of life
Time frame: five years
Functional results and quality of life after coloanal anastomosis with colonic reservoir

1 secondary outcome

Morbidity and cost-effectiveness
Time frame: 30 days

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 2 Oct 2012.
Derived from this study: PubMed 22981362Biondo S, Frago R, Codina Cazador A, Farres R, Olivet F, Golda T, Miguel B, Kreisler E. Long-term functional results from a randomized clinical study of transverse coloplasty compared with colon J-pouch after low anterior resection for rectal cancer. Surgery. 2013 Mar;153(3):383-92. doi: 10.1016/j.surg.2012.08.012. Epub 2012 Sep 14.

Related trials for Low Rectal Adenocarcinoma

RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
SCRT + Fruquintinib + Tislelizumab + CAPOX Versus SCRT + Tislelizumab + CAPOX as Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer
Rectal Neoplasms, Rectal Cancer, Adenocarcinoma
RecruitingPhase 2
Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer
Colorectal Cancer (CRC)
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
RecruitingPhase 1
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Advanced or Metastatic Solid Tumor

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?

An observational study of Low Rectal Adenocarcinoma, run by Hospital Universitari de Bellvitge.

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 5 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: finished, as of the sponsor's last update on 2 Oct 2012. 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?

Quality of life (time frame: five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01396928, which also lists 1 linked publication.

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 2 Oct 2012.