Rectal CancerSAVENCT01006577
Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)
A study testing side-to-end anastomosis and colon j pouch in people with Rectal Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- side-to-end anastomosis and colon j pouch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- synchronous metastasis
- age > 80 years
- previous colon resection
- inflammatory bowel disease
- previous pelvic malignant tumor
- no anterior resection/ TME possible
Show all 10Show fewer
- synchronous other malignant disease
- emergency operation
- local excision by colonoscopy possible
- unability to complete or comprehend the preoperative questionnaire
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Campus Benjamin Franklin; Hindenburgdamm 30
Berlin, State of Berlin, D-12200
Johannes C Lauscher, MD, 0049 30 8445 2543, johannes.lauscher@charite.de
About this study
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
Read the 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
- Being tested
- side-to-end anastomosis, colon j pouch
- 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
- Medical subject headings
- Rectal Neoplasms, Fecal Incontinence, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
side-to-end anastomosisProcedure or surgery
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.
colon j pouchProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: side-to-end anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side-to-end anastomosis is not inferior not colon J pouch in terms of fecal incontinence. fecal incontinence (Wexner score)
Measured: First patient in to last patient out: 03/2010 -03/2015
Secondary outcomes (9)
anorectal function
Measured: 03/2010-03/2015
quality of life
Measured: 03/2010-03/2015
postoperative complications
Measured: 03/2010-03/2015
sexual function
Measured: 03/2010-03/2015
urinary function
Measured: 03/2010-03/2015
operation time
Measured: 03/2010-03/2015
institutional costs
Measured: 03/2010-03/2015
local recurrence
Measured: 03/2010-03/2015
cancer related deaths
Measured: 03/2010-03/2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startJun 2010
- Primary completionJul 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- ChirNet
- Investigators
- Johannes C Lauscher, MD, Principal investigator, Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic SurgeryJörg-Peter Ritz, PD Dr., Principal investigator, Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic SurgeryHeinz J Buhr, Prof. Dr., Study chair, Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006577
- Sponsor's protocol ID
- EA4/105/08
- Acronym
- SAVE
- Status last verified
- Nov 2009
- First submitted
- 19 Oct 2009
- Last updated
- 3 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)
- ClinicalTrials.gov ID
- NCT01006577
- Acronym / sponsor ID
- SAVE / EA4/105/08
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- ChirNet
- Study start
- Jun 2010
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colon j pouch | Other | Procedure: colon j pouchControl 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. |
| side-to-end anastomosis (STE) | Experimental | Procedure: side-to-end anastomosisExperimental 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- synchronous metastasis
- age > 80 years
- previous colon resection
- inflammatory bowel disease
- previous pelvic malignant tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| side-to-end anastomosisLow 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 or surgery | side-to-end anastomosis (STE) |
| colon j pouchLow 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. | Procedure or surgery | colon j pouch |
Primary outcome
Side-to-end anastomosis is not inferior not colon J pouch in terms of fecal incontinence. fecal incontinence (Wexner score)
Time frame: First patient in to last patient out: 03/2010 -03/2015
9 secondary outcomes
anorectal function
Time frame: 03/2010-03/2015
quality of life
Time frame: 03/2010-03/2015
postoperative complications
Time frame: 03/2010-03/2015
sexual function
Time frame: 03/2010-03/2015
urinary function
Time frame: 03/2010-03/2015
operation time
Time frame: 03/2010-03/2015
institutional costs
Time frame: 03/2010-03/2015
local recurrence
Time frame: 03/2010-03/2015
cancer related deaths
Time frame: 03/2010-03/2015
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2009.
- Homepage of Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic SurgeryLink provided by the sponsor.
- Homepage of the Coordinating Center for Clinical Studies (Monitoring of the study)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes C Lauscher, MD principal investigator
Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
Jörg-Peter Ritz, PD Dr. principal investigator
Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
Heinz J Buhr, Prof. Dr. study chair
Charité Campus Benjamin Franklin; Department of General, Vascular and Thoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing side-to-end anastomosis and colon j pouch in people with Rectal Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes C Lauscher, MD (0049 30 8445 2543, johannes.lauscher@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side-to-end anastomosis is not inferior not colon J pouch in terms of fecal incontinence. fecal incontinence (Wexner score) (time frame: First patient in to last patient out: 03/2010 -03/2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2009.