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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Perioperative/Postoperative Complications; Gastrointestinal Complications
• Intervention / Treatment: Procedure: therapeutic conventional surgery; Procedure: quality-of-life assessment; Procedure: assessment of therapy complications; Other: intraoperative complication management/prevention; Procedure: gastrointestinal complications management/prevention

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50134
    • Recruiting
    • Universita Degli Studi di Florence - Policlinico di Careggi
    • Contact: Contact Person; Phone Number: 39-55-794-7449; Email: f.tonelli@dfc.unifi.it
  • Milan, Italy, 20133
    • Recruiting
    • Fondazione Istituto Nazionale dei Tumori
    • Contact: Contact Person; Phone Number: 39-2-5501-8044; Email: ermanno.leo@istitutotumori.mi.it
  • Padova, Italy, 35128
    • Recruiting
    • Azienda Ospedaliera di Padova
    • Contact: Contact Person; Phone Number: 39-49-821-2055; Email: donato.nitti@unipd.it
  • San Vito Al Talgliamento, Italy
    • Recruiting
    • Ospedale Civile Di San Vito Al Tagliamento
    • Contact: Contact Person; Phone Number: 39-434-841-351; Email: ainfantino@libero.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Major anastomotic leak rate

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Padova
• Investigators: Principal Investigator: Donato Nitti, MD, Azienda Ospedaliera di Padova

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 23, 2010
• First Posted (Estimate): April 27, 2010

Study Record Updates

• Last Update Posted (Estimate): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; gastrointestinal complications; stage II rectal cancer; stage III rectal cancer; perioperative/postoperative complications; stage I rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Postoperative Complications
• Other Study ID Numbers: CDR0000671070; USP-1935P; EU-21032