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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01006577
Acronym
SAVE
Enrollment
306
Registered
2009-11-03
Start date
2010-06-30
Completion date
2015-10-31
Last updated
2009-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

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.

PROCEDUREcolon 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

ChirNet
CollaboratorUNKNOWN
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
quality of life03/2010-03/2015
postoperative complications03/2010-03/2015
sexual function03/2010-03/2015
urinary function03/2010-03/2015
anorectal function03/2010-03/2015
institutional costs03/2010-03/2015
local recurrence03/2010-03/2015
cancer related deaths03/2010-03/2015
operation time03/2010-03/2015

Countries

Germany

Contacts

Primary ContactJohannes C Lauscher, MD
johannes.lauscher@charite.de0049 30 8445 2543
Backup ContactJörg-Peter Ritz, PD Dr.
joerg-peter.ritz@charite.de0049 30 8445 2503

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026