Colorectal CancerNCT01110798
J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor
A study testing intraoperative complication management/prevention, assessment of therapy complications and gastrointestinal complications management/prevention in people with Colorectal Cancer and Gastrointestinal Complications, run by Azienda Ospedaliera di Padova at 4 sites in Italy.
Trial summary
RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective than a straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Gastrointestinal Complications, Perioperative/Postoperative Complications
- What is being tested?
- intraoperative complication management/prevention, assessment of therapy complications and gastrointestinal complications management/prevention
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 4 sitesItaly
- Study dates
- Oct 2009to Oct 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed rectal adenocarcinoma meeting the following criteria:
- Mid and/or low rectal cancer
- Tumor site ≤ 11 cm from anal verge
- Must have a temporary stoma (ileostomy or colostomy)
- Must be scheduled for a total mesorectal excision with a low anterior rectal resection and mechanic colorectal anastomosis that is potentially curative or with a microscopic residual resection (R0-R1)
- No locally recurrent disease
- No distant metastasis
PATIENT CHARACTERISTICS:
- Must be able to understand the study
PRIOR CONCURRENT THERAPY:
- No prior handsewn coloanal anastomosis
- No prior colonic resection
- No prior surgery for local recurrence
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
Universita Degli Studi di Florence - Policlinico di Careggi
Florence, 50134
Contact Person, 39-55-794-7449, f.tonelli@dfc.unifi.it
- Recruiting
Fondazione Istituto Nazionale dei Tumori
Milan, 20133
Contact Person, 39-2-5501-8044, ermanno.leo@istitutotumori.mi.it
- Recruiting
Azienda Ospedaliera di Padova
Padova, 35128
Contact Person, 39-49-821-2055, donato.nitti@unipd.it
- Recruiting
Ospedale Civile Di San Vito Al Tagliamento
San Vito Al Talgliamento
Contact Person, 39-434-841-351, ainfantino@libero.it
About this study
Official title: Colonic J-Pouch Reconstruction Versus Straight Colorectal Anastomosis After Low Anterior Resection for Rectal Cancer: Impact on Anastomotic Leak, Bowel Function and Quality of Life
RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective than a straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.
PURPOSE: This randomized clinical trial is studying J-pouch colorectal anastomosis to see how well it works compared with straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.
Read the detailed description
OBJECTIVES:
Primary
- To assess whether the incidence of major anastomotic leak after low anterior resection, in patients with rectal cancer, is reduced by using the J-pouch reconstruction vs straight colorectal anastomosis.
Secondary
- To compare the global anastomotic leak (major and minor) rate, the incidence of other complications in addition to anastomotic leak, and the functional outcome and the quality of life in these patients.
- To describe, in the J-pouch reconstruction group, the feasibility of the colonic J-pouch.
OUTLINE: Ths is a multicenter study. Patients are stratified according to clinical center, gender (male vs female), and neoadjuvant treatment types. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical straight stapled colorectal anastomosis.
- Arm II: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical J-pouch stapled anastomosis reconstruction.
Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), and the MSKCC Bowel Function Questionnaire.
After completion of study treatment, patients are followed at 1, 6, 12, and 24 months.
- Conditions
- Colorectal Cancer, Gastrointestinal Complications, Perioperative/Postoperative Complications
- Being tested
- intraoperative complication management/prevention, assessment of therapy complications, gastrointestinal complications management/prevention, quality-of-life assessment, therapeutic conventional surgery
- Keywords
- perioperative/postoperative complications, gastrointestinal complications, adenocarcinoma of the rectum, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative complication management/preventionOther
assessment of therapy complicationsProcedure or surgery
gastrointestinal complications management/preventionProcedure or surgery
quality-of-life assessmentProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Major anastomotic leak rate
Secondary outcomes (4)
Percentage of the colonic J-pouch reconstruction performed with respect to the total number of patients selected for the J-pouch treatment arm
Global anastomotic leak rate
Anastomotic complications rate in addition to anastomotic leak
Bowel function, fecal incontinence, and quality of life, evaluated with validated questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Investigators
- Donato Nitti, MD, Principal investigator, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110798
- Sponsor's protocol ID
- CDR0000671070
- Other IDs
- USP-1935P, EU-21032
- Status last verified
- Feb 2011
- First submitted
- 23 Apr 2010
- Last updated
- 17 Sep 2013
- Results posted
- No
Publications
Gavaruzzi T, Pace U, Giandomenico F, Pucciarelli S, Bianco F, Selvaggi F, Restivo A, Asteria CR, Morpurgo E, Cuicchi D, Jovine E, Coletta D, La Torre G, Amato A, Chiappa A, Marchegiani F, Rega D, De Franciscis S, Pellino G, Zorcolo L, Lotto L, Boccia L, Spolverato G, De Salvo GL, Delrio P, Del Bianco P. Colonic J-Pouch or Straight Colorectal Reconstruction After Low Anterior Resection For Rectal Cancer: Impact on Quality of Life and Bowel Function: A Multicenter Prospective Randomized Study. Dis Colon Rectum. 2020 Nov;63(11):1511-1523. doi: 10.1097/DCR.0000000000001745.
PubMed 33044292Jakob MO, Haltmeier T, Candinas D, Beldi G. Biologic mesh implantation is associated with serious abdominal wall complications in patients undergoing emergency abdominal surgery: A randomized-controlled clinical trial. J Trauma Acute Care Surg. 2020 Dec;89(6):1149-1155. doi: 10.1097/TA.0000000000002877.
PubMed 32649617Pucciarelli S, Del Bianco P, Pace U, Bianco F, Restivo A, Maretto I, Selvaggi F, Zorcolo L, De Franciscis S, Asteria C, Urso EDL, Cuicchi D, Pellino G, Morpurgo E, La Torre G, Jovine E, Belluco C, La Torre F, Amato A, Chiappa A, Infantino A, Barina A, Spolverato G, Rega D, Kilmartin D, De Salvo GL, Delrio P. Multicentre randomized clinical trial of colonic J pouch or straight stapled colorectal reconstruction after low anterior resection for rectal cancer. Br J Surg. 2019 Aug;106(9):1147-1155. doi: 10.1002/bjs.11222. Epub 2019 Jun 24.
PubMed 31233220
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonic J-Pouch Reconstruction Versus Straight Colorectal Anastomosis After Low Anterior Resection for Rectal Cancer: Impact on Anastomotic Leak, Bowel Function and Quality of Life
- ClinicalTrials.gov ID
- NCT01110798
- Acronym / sponsor ID
- CDR0000671070
- Conditions
- Colorectal Cancer, Gastrointestinal Complications, Perioperative/Postoperative Complications
- Keywords
- perioperative/postoperative complications, gastrointestinal complications, adenocarcinoma of the rectum, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (estimated)
- First posted
- 27 Apr 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.
RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective than a straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.
PURPOSE: This randomized clinical trial is studying J-pouch colorectal anastomosis to see how well it works compared with straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.
Detailed description
OBJECTIVES:
Primary
- To assess whether the incidence of major anastomotic leak after low anterior resection, in patients with rectal cancer, is reduced by using the J-pouch reconstruction vs straight colorectal anastomosis.
Secondary
- To compare the global anastomotic leak (major and minor) rate, the incidence of other complications in addition to anastomotic leak, and the functional outcome and the quality of life in these patients.
- To describe, in the J-pouch reconstruction group, the feasibility of the colonic J-pouch.
OUTLINE: Ths is a multicenter study. Patients are stratified according to clinical center, gender (male vs female), and neoadjuvant treatment types. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical straight stapled colorectal anastomosis.
- Arm II: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical J-pouch stapled anastomosis reconstruction.
Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), and the MSKCC Bowel Function Questionnaire.
After completion of study treatment, patients are followed at 1, 6, 12, and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| intraoperative complication management/prevention | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| gastrointestinal complications management/prevention | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
Primary outcome
Major anastomotic leak rate
4 secondary outcomes
Percentage of the colonic J-pouch reconstruction performed with respect to the total number of patients selected for the J-pouch treatment arm
Global anastomotic leak rate
Anastomotic complications rate in addition to anastomotic leak
Bowel function, fecal incontinence, and quality of life, evaluated with validated questionnaires
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Derived from this study: PubMed 33044292Gavaruzzi T, Pace U, Giandomenico F, Pucciarelli S, Bianco F, Selvaggi F, Restivo A, Asteria CR, Morpurgo E, Cuicchi D, Jovine E, Coletta D, La Torre G, Amato A, Chiappa A, Marchegiani F, Rega D, De Franciscis S, Pellino G, Zorcolo L, Lotto L, Boccia L, Spolverato G, De Salvo GL, Delrio P, Del Bianco P. Colonic J-Pouch or Straight Colorectal Reconstruction After Low Anterior Resection For Rectal Cancer: Impact on Quality of Life and Bowel Function: A Multicenter Prospective Randomized Study. Dis Colon Rectum. 2020 Nov;63(11):1511-1523. doi: 10.1097/DCR.0000000000001745.
- Derived from this study: PubMed 32649617Jakob MO, Haltmeier T, Candinas D, Beldi G. Biologic mesh implantation is associated with serious abdominal wall complications in patients undergoing emergency abdominal surgery: A randomized-controlled clinical trial. J Trauma Acute Care Surg. 2020 Dec;89(6):1149-1155. doi: 10.1097/TA.0000000000002877.
- Derived from this study: PubMed 31233220Pucciarelli S, Del Bianco P, Pace U, Bianco F, Restivo A, Maretto I, Selvaggi F, Zorcolo L, De Franciscis S, Asteria C, Urso EDL, Cuicchi D, Pellino G, Morpurgo E, La Torre G, Jovine E, Belluco C, La Torre F, Amato A, Chiappa A, Infantino A, Barina A, Spolverato G, Rega D, Kilmartin D, De Salvo GL, Delrio P. Multicentre randomized clinical trial of colonic J pouch or straight stapled colorectal reconstruction after low anterior resection for rectal cancer. Br J Surg. 2019 Aug;106(9):1147-1155. doi: 10.1002/bjs.11222. Epub 2019 Jun 24.
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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.
Universita Degli Studi di Florence - Policlinico di Careggi
Florence, Italy
Donato Nitti, MD principal investigator
Azienda Ospedaliera di Padova
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative complication management/prevention, assessment of therapy complications and gastrointestinal complications management/prevention in people with Colorectal Cancer and Gastrointestinal Complications, run by Azienda Ospedaliera di Padova at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major anastomotic leak rate. 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 NCT01110798, which also lists 3 linked publications.
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 17 Sep 2013.