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

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:

MedlinePlus related topics: Bowel Movement Cancer Plastic and Cosmetic Surgery

U.S. FDA Resources

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.

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

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:

Homepage of Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery This link exits the ClinicalTrials.gov site

Homepage of the Coordinating Center for Clinical Studies (Monitoring of the study) This link exits the ClinicalTrials.gov site

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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013