Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2009 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
ChirNet
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01006577
First received: October 19, 2009
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

Primary hypothesis: Side-to-end anastomosis is non-inferior to colon J pouch for reconstruction after low anterior resection for rectal cancer in fecal incontinence (Wexner score).

Research questions: Are there differences between side-to-end anastomosis and colon J pouch in

  • bowel function (fecal incontinence, frequency of bowel movements, rectal urgency, incomplete evacuation)
  • quality of life
  • sexual function
  • urinary function
  • postoperative complications
  • operation time/ institutional costs

Condition Intervention
Rectal Cancer
Procedure: side-to-end anastomosis
Procedure: colon j pouch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Side-to-end anastomosis is not inferior not colon J pouch in terms of fecal incontinence. fecal incontinence (Wexner score) [ Time Frame: First patient in to last patient out: 03/2010 -03/2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anorectal function [ Time Frame: 03/2010-03/2015 ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 03/2010-03/2015 ] [ Designated as safety issue: No ]
  • postoperative complications [ Time Frame: 03/2010-03/2015 ] [ Designated as safety issue: No ]
  • sexual function [ Time Frame: 03/2010-03/2015 ] [ Designated as safety issue: No ]
  • urinary function [ Time Frame: 03/2010-03/2015 ] [ Designated as safety issue: No ]
  • operation time [ Time Frame: 03/2010-03/2015 ] [ Designated as safety issue: No ]
  • institutional costs [ Time Frame: 03/2010-03/2015 ] [ Designated as safety issue: No ]
  • local recurrence [ Time Frame: 03/2010-03/2015 ] [ Designated as safety issue: No ]
  • cancer related deaths [ Time Frame: 03/2010-03/2015 ] [ Designated as safety issue: No ]

Estimated Enrollment: 306
Study Start Date: June 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
colon j pouch
Control intervention: Low anterior resection for rectal cancer with total mesorectal excision (TME), ligation of the inferior mesenteric artery, mobilization of the splenic flexure, radical lymph node dissection and colon J pouch rectal/colon J pouch anal anastomosis (CJP). The colon J Pouch is formed by the descending colon by stapling. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
Procedure: colon j pouch
Low anterior resection for rectal cancer with total mesorectal excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization of the splenic flexure, radical lymph node dissection and colon J pouch rectal/colon J pouch anal anastomosis (CJP). The colon J Pouch is formed by the descending colon by stapling with a defined pouch limb length of 5-6 cm, which is measured intraoperatively. The stapling is done by introducing the stapler from the anus by the assistant surgeon while the surgeon is holding the descending colon in the correct position. The integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
Experimental: side-to-end anastomosis (STE)
Experimental intervention: Low anterior resection for rectal cancer < 12 cm from the anal verge with total mesorectal excision (TME), ligation of the inferior mesenteric artery, mobilization of the splenic flexure, radical lymph node dissection and side-to-end colorectal/ coloanal anastomosis (STE). The blind end of the descending colon is closed with a linear stapler. The length of the blind end is measured and the integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
Procedure: side-to-end anastomosis
Low anterior resection for rectal cancer < 12 cm from the anal verge with total mesorectal excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization of the splenic flexure, radical lymph node dissection and side-to-end colorectal/ coloanal anastomosis (STE). The blind end of the descending colon (3-5 cm long) is closed with a linear stapler. Stapling of the anastomosis is done by introducing the stapler from the anus by the assistant surgeon while the surgeon is holding the descending colon in the correct position. The anastomosis is performed on the antimesenteric aspect of the descending colon. The length of the blind end is measured and the integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.

Detailed Description:

Experimental intervention: Low anterior resection for rectal cancer < 12 cm from the anal verge with total mesorectal excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization of the splenic flexure, radical lymph node dissection and side-to-end colorectal/ coloanal anastomosis (STE). The blind end of the descending colon (3-5 cm long) is closed with a linear stapler. Stapling of the anastomosis is done by introducing the stapler from the anus by the assistant surgeon while the surgeon is holding the descending colon in the correct position. The anastomosis is performed on the antimesenteric aspect of the descending colon. The length of the blind end is measured and the integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.

Control intervention: Low anterior resection for rectal cancer with total mesorectal excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization of the splenic flexure, radical lymph node dissection and colon J pouch rectal/colon J pouch anal anastomosis (CJP). The colon J Pouch is formed by the descending colon by stapling with a defined pouch limb length of 5-6 cm, which is measured intraoperatively. The stapling is done by introducing the stapler from the anus by the assistant surgeon while the surgeon is holding the descending colon in the correct position. The integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.

Follow-up per patient: 24 months postoperatively

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with histological proven middle to low rectal cancer (< 12 cm from the anal verge) requiring low anterior resection with TME
  • with or without (neo)-adjuvant radiochemotherapy
  • age ≥18 years
  • normal preoperative sphincter status (Wexner score = 0)

Exclusion Criteria:

  • synchronous metastasis
  • age > 80 years
  • previous colon resection
  • inflammatory bowel disease
  • previous pelvic malignant tumor
  • no anterior resection/ TME possible
  • synchronous other malignant disease
  • emergency operation
  • local excision by colonoscopy possible
  • unability to complete or comprehend the preoperative questionnaire
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006577

Contacts
Contact: Johannes C Lauscher, MD 0049 30 8445 2543 johannes.lauscher@charite.de
Contact: Jörg-Peter Ritz, PD Dr. 0049 30 8445 2503 joerg-peter.ritz@charite.de

Locations
Germany
Charité Campus Benjamin Franklin; Hindenburgdamm 30 Not yet recruiting
Berlin, Germany, D-12200
Contact: Johannes C Lauscher, MD    0049 30 8445 2543    johannes.lauscher@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
ChirNet
Investigators
Principal Investigator: Johannes C Lauscher, MD Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
Principal Investigator: Jörg-Peter Ritz, PD Dr. Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
Study Chair: Heinz J Buhr, Prof. Dr. Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Johannes Lauscher; PD Dr. Jörg-Peter Ritz, Department of General, Vascular and Thoracic Surgery; Charité Campus Benjamin Franklin
ClinicalTrials.gov Identifier: NCT01006577     History of Changes
Other Study ID Numbers: EA4/105/08
Study First Received: October 19, 2009
Last Updated: November 2, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
rectal cancer
side-to-end anastomosis
colon J pouch
fecal incontinence
anorectal function
Are there differences between side-to-end anastomosis and colon J pouch in
bowel function (fecal incontinence, frequency of bowel movements, rectal urgency, incomplete evacuation)
quality of life
postoperative complications
operation time/ institutional costs

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 29, 2014