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

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

Interventions

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.

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.

Sponsors & Collaborators

• ChirNet

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Johannes C Lauscher, MD · Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery

• Jörg-Peter Ritz, PD Dr. · Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery

• Heinz J Buhr, Prof. Dr. · Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2015-07-31

Completion

2015-10-31

Countries

• Germany

Study Locations