Rectal CancerCSARNCT03074461
Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial
A study testing Side-to-End Anastomosis and Transverse Coloplasty in people with Rectal Cancer and Rectal Neoplasms, run by Ludwig-Maximilians - University of Munich at 3 sites in Germany.
Trial summary
CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Rectal Neoplasms, Rectal Tumors
- What is being tested?
- Side-to-End Anastomosis and Transverse Coloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesGermany
- Study dates
- 5 Apr 2017to Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled low anterior resection in patients with distal rectal carcinoma and planned anastomosis in mid/distal third of rectum
- Local curative approach
- Normal continence preoperatively
- Non-IBD-associated carcinoma
- Possible sphincter salvage
- Signed informed consent
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- Life expectancy less than 24 months (as estimated by the treating physicians)
- Pregnancy
- Immunosuppression
Who cannot join
- Non-curative approaches
- Emergency surgery in cases of tumor perforation, abscess, sepsis
- Proximal rectal carcinoma (> 12 cm from anocutaneous line)
- Lack of informed consent
- Age <18 years
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Not yet recruiting
Maria-Theresia-Klinik
München, Bavaria, 80336
Andreas Hölscher, MD, 0049/89/7207325, dr.hoelscher@maria-theresia-klinik.de
Carolin Orlitsch, MD, 0049/89/7207325, dr.orlitsch@maria-theresia-klinik.de
- Not yet recruiting
Krankenhaus Barmherzige Brüder München
München, Bavaria, 80639
Johann Spatz, MD, 0049/89/17972302, johann.spatz@barmherzige-muenchen.de
- Recruiting
Klinikum der Universität München
München, Bavaria, 81377
Markus Rentsch, MD, 0049/89/4400/711213, markus.rentsch@med.uni-muenchen.de
Sandro M Hasenhütl, MD, 0049/89/4400/711242, sandro.hasenhuetl@med.uni-muenchen.de
About this study
CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.
Read the detailed description
This study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. Its focus is on the functional results. Besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.
- Conditions
- Rectal Cancer, Rectal Neoplasms, Rectal Tumors, Fecal Incontinence
- Being tested
- Side-to-End Anastomosis, Transverse Coloplasty
- Keywords
- Rectal Cancer, Low Anterior Resection, Coloplasty Pouch, Side-to-end Anastomosis, Continence, Quality of Life
- Medical subject headings
- Rectal Neoplasms, Fecal Incontinence
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
During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a side-to-end colorectal anastomosis.
Transverse ColoplastyProcedure or surgery
Also called Coloplasty Pouch, Transverse Coloplasty Pouch
During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a transverse coloplasty pouch. For this purpose an end-to-end colorectal anastomosis is initially performed, followed by a longitudinal incision of approx. 8-10 cm length proximal of the anastomosis and a subsequent transverse suture in terms of the coloplasty technique.
| Study group | Role | What they receive |
|---|---|---|
| Side-to-End | Experimental | Side-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR) Receives: Procedure: Side-to-End Anastomosis |
| Transverse Coloplasty | Active comparator | Transverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR) Receives: Procedure: Transverse Coloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
Between group differences in stool frequency at t = 6 months postoperative
Measured: time = 6 months postoperative
Secondary outcomes (3)
Postoperative complications
- Septic intraabdominal complications related to anastomosis (anastomotic insufficiencies, suture insufficiencies, abscesses);
- Wound infection
Measured: through study completion (an average of 12 months postoperative)
Quality of Life
Quality of Life with focus on colorectally specialized questionnaires
Measured: baseline, postoperative (2-3 months, 6 months, 12 months)
Antimotility drug usage
Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires
Measured: baseline, postoperative (2-3 months, 6 months, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start5 Apr 2017
- Primary completionSep 2019 (estimated)
- Study completionMar 2020 (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.
- 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
- Model description
- Study participants will be randomized in two parallel study arms regarding their neorectal reconstruction in low anterior resection, the experimental arm using the side-to-end anastomosis and the control group using the transverse coloplasty technique.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Rentsch, Ludwig-Maximilians - University of Munich
- Investigators
- Markus Rentsch, MD, Principal investigator, Department of General, Visceral, and Transplantation Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074461
- Sponsor's protocol ID
- 17-129
- Acronym
- CSAR
- Status last verified
- May 2017
- First submitted
- 26 Feb 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to third parties beyond the study team.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial
- ClinicalTrials.gov ID
- NCT03074461
- Acronym / sponsor ID
- CSAR / 17-129
- Conditions
- Rectal Cancer, Rectal Neoplasms, Rectal Tumors, Fecal Incontinence
- Keywords
- Rectal Cancer, Low Anterior Resection, Coloplasty Pouch, Side-to-end Anastomosis, Continence, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 8 Mar 2017 (actual)
- 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.
CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.
Detailed description
This study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. Its focus is on the functional results. Besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants will be randomized in two parallel study arms regarding their neorectal reconstruction in low anterior resection, the experimental arm using the side-to-end anastomosis and the control group using the transverse coloplasty technique.
| Arm | Type | Receives |
|---|---|---|
| Side-to-End | Experimental | Procedure: Side-to-End AnastomosisSide-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR) |
| Transverse Coloplasty | Active comparator | Procedure: Transverse ColoplastyTransverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Scheduled low anterior resection in patients with distal rectal carcinoma and planned anastomosis in mid/distal third of rectum
- Local curative approach
- Normal continence preoperatively
- Non-IBD-associated carcinoma
- Possible sphincter salvage
Key exclusion criteria (5 listed)
- Non-curative approaches
- Emergency surgery in cases of tumor perforation, abscess, sepsis
- Proximal rectal carcinoma (> 12 cm from anocutaneous line)
- Lack of informed consent
- Age <18 years
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 AnastomosisDuring the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a side-to-end colorectal anastomosis. | Procedure or surgery | Side-to-End |
| Transverse ColoplastyAlso: Coloplasty Pouch, Transverse Coloplasty PouchDuring the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a transverse coloplasty pouch. For this purpose an end-to-end colorectal anastomosis is initially performed, followed by a longitudinal incision of approx. 8-10 cm length proximal of the anastomosis and a subsequent transverse suture in terms of the coloplasty technique. | Procedure or surgery | Transverse Coloplasty |
Primary outcome
Stool frequency
Time frame: time = 6 months postoperative
Between group differences in stool frequency at t = 6 months postoperative
3 secondary outcomes
Postoperative complications
Time frame: through study completion (an average of 12 months postoperative)
Quality of Life
Time frame: baseline, postoperative (2-3 months, 6 months, 12 months)
Antimotility drug usage
Time frame: baseline, postoperative (2-3 months, 6 months, 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to third parties beyond the study team.
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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.
Markus Rentsch, MD principal investigator
Department of General, Visceral, and Transplantation Surgery
3 sites 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 Transverse Coloplasty in people with Rectal Cancer and Rectal Neoplasms, run by Ludwig-Maximilians - University of Munich at 3 sites 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 9 inclusion and 5 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Markus Rentsch, MD (0049/89/4400/711213, markus.rentsch@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool frequency (time frame: time = 6 months postoperative). 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 1 Jun 2017.