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

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

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: colon j pouch; Procedure: side-to-end anastomosis

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

• Study Type: Interventional
• Enrollment (Anticipated): 306
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johannes C Lauscher, MD; Phone Number: 0049 30 8445 2543; Email: johannes.lauscher@charite.de
• Study Contact Backup: Name: Jörg-Peter Ritz, PD Dr.; Phone Number: 0049 30 8445 2503; Email: joerg-peter.ritz@charite.de

Study Locations

• Germany
  • Berlin, Germany, D-12200
    • Charité Campus Benjamin Franklin; Hindenburgdamm 30
    • Contact: Johannes C Lauscher, MD; Phone Number: 0049 30 8445 2543; Email: johannes.lauscher@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Side-to-end anastomosis is not inferior not colon J pouch in terms of fecal incontinence. fecal incontinence (Wexner score)	First patient in to last patient out: 03/2010 -03/2015

Secondary Outcome Measures

Outcome Measure	Time Frame
anorectal function	03/2010-03/2015
quality of life	03/2010-03/2015
postoperative complications	03/2010-03/2015
sexual function	03/2010-03/2015
urinary function	03/2010-03/2015
operation time	03/2010-03/2015
institutional costs	03/2010-03/2015
local recurrence	03/2010-03/2015
cancer related deaths	03/2010-03/2015

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: 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

Publications and helpful links

Helpful Links

• Homepage of the Coordinating Center for Clinical Studies (Monitoring of the study)

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: October 19, 2009
• First Submitted That Met QC Criteria: November 2, 2009
• First Posted (Estimate): November 3, 2009

Study Record Updates

• Last Update Posted (Estimate): November 3, 2009
• Last Update Submitted That Met QC Criteria: November 2, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: quality of life; rectal cancer; postoperative complications; fecal incontinence; side-to-end anastomosis; colon J pouch; 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); operation time/ institutional costs
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: EA4/105/08