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

Rectal Cancer Clinical Trial

— SAVE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01006577
• Other study ID #: EA4/105/08
• Status: Not yet recruiting
• Phase: N/A
• First received: October 19, 2009
• Last updated: November 2, 2009
• Start date: June 2010
• Est. completion date: October 2015

Study information

• Verified date: November 2009
• Source: Charite University, Berlin, Germany
• Contact: Johannes C Lauscher, MD
• Phone: 0049 30 8445 2543
• Email: johannes.lauscher[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 306
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Charité Campus Benjamin Franklin; Hindenburgdamm 30	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	ChirNet

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	anorectal function		03/2010-03/2015	No
Secondary	quality of life		03/2010-03/2015	No
Secondary	postoperative complications		03/2010-03/2015	No
Secondary	sexual function		03/2010-03/2015	No
Secondary	urinary function		03/2010-03/2015	No
Secondary	operation time		03/2010-03/2015	No
Secondary	institutional costs		03/2010-03/2015	No
Secondary	local recurrence		03/2010-03/2015	No
Secondary	cancer related deaths		03/2010-03/2015	No

External Links

•   Homepage of Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
•   Homepage of the Coordinating Center for Clinical Studies (Monitoring of the study)