J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor
NCT ID: NCT01110798
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2009-10-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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intraoperative complication management/prevention
assessment of therapy complications
gastrointestinal complications management/prevention
quality-of-life assessment
therapeutic conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera di Padova
OTHER
Principal Investigators
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Donato Nitti, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera di Padova
Locations
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Universita Degli Studi di Florence - Policlinico di Careggi
Florence, , Italy
Fondazione Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Ospedale Civile Di San Vito Al Tagliamento
San Vito Al Talgliamento, , Italy
Countries
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Facility Contacts
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Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
References
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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.
Jakob 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.
Pucciarelli 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.
Other Identifiers
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USP-1935P
Identifier Type: -
Identifier Source: secondary_id
EU-21032
Identifier Type: -
Identifier Source: secondary_id
CDR0000671070
Identifier Type: -
Identifier Source: org_study_id