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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01110798
• Other study ID #: CDR0000671070
• Secondary ID: USP-1935PEU-2103
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2010
• Last updated: September 16, 2013
• Start date: October 2009

Study information

• Verified date: February 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Gastrointestinal Complications
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Other:
• intraoperative complication management/prevention

Procedure:
• assessment of therapy complications

• gastrointestinal complications management/prevention

• quality-of-life assessment

• therapeutic conventional surgery

Locations

Country	Name	City	State
Italy	Universita Degli Studi di Florence - Policlinico di Careggi	Florence
Italy	Fondazione Istituto Nazionale dei Tumori	Milan
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Ospedale Civile Di San Vito Al Tagliamento	San Vito Al Talgliamento

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major anastomotic leak rate			No
Secondary	Percentage of the colonic J-pouch reconstruction performed with respect to the total number of patients selected for the J-pouch treatment arm			No
Secondary	Global anastomotic leak rate			No
Secondary	Anastomotic complications rate in addition to anastomotic leak			No
Secondary	Bowel function, fecal incontinence, and quality of life, evaluated with validated questionnaires			No