Clinical trial NCT01110798: J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-04-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major anastomotic leak rate
Secondary outcomes:
measure: Percentage of the colonic J-pouch reconstruction performed with respect to the total number of patients selected for the J-pouch treatment arm
measure: Global anastomotic leak rate
measure: Anastomotic complications rate in addition to anastomotic leak
measure: Bowel function, fecal incontinence, and quality of life, evaluated with validated questionnaires
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Universita Degli Studi di Florence - Policlinico di Careggi
city: Milan
country: Italy
facility: Fondazione Istituto Nazionale dei Tumori
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: San Vito Al Talgliamento
country: Italy
facility: Ospedale Civile Di San Vito Al Tagliamento
Study officials:
affiliation: Azienda Ospedaliera di Padova
name: Donato Nitti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.