J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor

NCT01110798 | Unknown

• 3 other identifiers: CDR0000671070USP-1935PEU-21032
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 4

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

intraoperative complication management/prevention OTHER

assessment of therapy complications PROCEDURE

gastrointestinal complications management/prevention PROCEDURE

quality-of-life assessment PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (4)

Universita Degli Studi di Florence - Policlinico di Careggi

Florence, 50134, Italy

RECRUITING

Fondazione Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Azienda Ospedaliera di Padova

Padua, 35128, Italy

RECRUITING

Ospedale Civile Di San Vito Al Tagliamento

San Vito Al Talgliamento, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 33044292 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.

  PMID: 32649617 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.

  PMID: 31233220 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Postoperative Complications; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Donato Nitti, MD

  Azienda Ospedaliera di Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 27, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Last Updated: September 17, 2013

Record last verified: 2011-02

Locations

IT (4)