Clinical trial NCT01006577: Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)
Official title: Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: ChirNet
First posted: 2009-11-03
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Side-to-end anastomosis is not inferior not colon J pouch in terms of fecal incontinence. fecal incontinence (Wexner score)
timeFrame: First patient in to last patient out: 03/2010 -03/2015
Secondary outcomes:
measure: anorectal function
timeFrame: 03/2010-03/2015
measure: quality of life
timeFrame: 03/2010-03/2015
measure: postoperative complications
timeFrame: 03/2010-03/2015
measure: sexual function
timeFrame: 03/2010-03/2015
measure: urinary function
timeFrame: 03/2010-03/2015
measure: operation time
timeFrame: 03/2010-03/2015
measure: institutional costs
timeFrame: 03/2010-03/2015
measure: local recurrence
timeFrame: 03/2010-03/2015
measure: cancer related deaths
timeFrame: 03/2010-03/2015
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin; Hindenburgdamm 30
Study officials:
affiliation: Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
name: Johannes C Lauscher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
name: Jörg-Peter Ritz, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
name: Heinz J Buhr, Prof. Dr.
role: STUDY_CHAIR
References: