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

NCT01006577 | Unknown DMC

• 1 other identifier: EA4/105/08
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

colon j pouch

OTHER

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

side-to-end anastomosis (STE)

EXPERIMENTAL

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

Interventions

side-to-end anastomosis PROCEDURE

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.

side-to-end anastomosis (STE)

colon j pouch PROCEDURE

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.

colon j pouch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• ChirNet: collaborator

Study Sites (1)

Charité Campus Benjamin Franklin; Hindenburgdamm 30

Berlin, State of Berlin, D-12200, Germany

Location

Related Links

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

MeSH Terms

Conditions

Rectal Neoplasms; Fecal Incontinence; Postoperative Complications

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Heinz J Buhr, Prof. Dr.

  Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery

  STUDY CHAIR

Central Study Contacts

Johannes C Lauscher, MD

CONTACT

0049 30 8445 2543; johannes.lauscher@charite.de

Jörg-Peter Ritz, PD Dr.

CONTACT

0049 30 8445 2503; joerg-peter.ritz@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: November 3, 2009
• Study Start: June 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 3, 2009

Record last verified: 2009-11

Locations

DE (1)