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

NCT ID: NCT01006577

Last Updated: 2009-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-10-31

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

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

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

colon j pouch

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

side-to-end anastomosis

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ChirNet

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

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

Principal Investigators

Johannes C Lauscher, MD

Role: PRINCIPAL_INVESTIGATOR

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

Jörg-Peter Ritz, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Heinz J Buhr, Prof. Dr.

Role: STUDY_CHAIR

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

Locations

Charité Campus Benjamin Franklin; Hindenburgdamm 30

Berlin, State of Berlin, Germany

Countries

Germany

Central Contacts

Johannes C Lauscher, MD

Role: CONTACT

johannes.lauscher@charite.de

0049 30 8445 2543

Jörg-Peter Ritz, PD Dr.

Role: CONTACT

joerg-peter.ritz@charite.de

0049 30 8445 2503

Facility Contacts

Johannes C Lauscher, MD

Role: primary

johannes.lauscher@charite.de

0049 30 8445 2543

Related Links

http://www.kks.charite.de

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

Other Identifiers

EA4/105/08

Identifier Type: -

Identifier Source: org_study_id