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| ID | Type | Description | Link |
|---|---|---|---|
| USP-1935P | |||
| EU-21032 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraoperative complication management/prevention | Other | |||
| assessment of therapy complications | Procedure | |||
| gastrointestinal complications management/prevention | Procedure | |||
| quality-of-life assessment | Procedure | |||
| therapeutic conventional surgery | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Major anastomotic leak rate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
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DISEASE CHARACTERISTICS:
Histologically confirmed rectal adenocarcinoma meeting the following criteria:
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Donato Nitti, MD | Azienda Ospedaliera di Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universita Degli Studi di Florence - Policlinico di Careggi | Recruiting | Florence | 50134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33044292 | Derived | 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. | |
| 32649617 |
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| Anastomotic complications rate in addition to anastomotic leak |
| Bowel function, fecal incontinence, and quality of life, evaluated with validated questionnaires |
| Fondazione Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
|
| Azienda Ospedaliera di Padova | Recruiting | Padova | 35128 | Italy |
|
| Ospedale Civile Di San Vito Al Tagliamento | Recruiting | San Vito Al Talgliamento | Italy |
|
| Derived |
| 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. |
| 31233220 | Derived | 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. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011183 | Postoperative Complications |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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