Rectal CancerLessStoReSNCT02279771
Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery
A study testing transanal anastomotic reinforcement, protective ileostomy group and a circular anal dilator (CAD) in people with Rectal Cancer, run by Donato F Altomare at 1 site in Italy.
Trial summary
Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- transanal anastomotic reinforcement, protective ileostomy group and a circular anal dilator (CAD)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Dec 2022
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resectable, histologically proven primary adenocarcinoma of the medium-low rectum without internal and/or external sphincter muscle involvement.
- Distal margin of the tumor at least 6 cm form the anal verge
- Staged as follows prior to neoadjuvant chemoradiation:
- Stage T2 - T4 at MRI N0-2 at MRI M0/M1 at CT scan Patient classified T3-T4 must undergo neoadjuvant chemoradiation with at least 8 weeks delay of surgery
Who cannot join
- Squamous cell carcinoma
- Adenocarcinoma Stage T1,
- T4 with one of the following:
- with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total)
- Unresectable primary rectal cancer or Inability to complete R0 resection.
- Rectal cancer under 6 cm from the anal verge requiring colo-anal anastomosis
Show all 10Show fewer
- Recurrent rectal cancer
- Previous pelvic malignancy
- Inability to sign informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Randomized Controlled Trial of Transanal Reinforcement of Low Rectal Anastomosis Versus Protective Ileostomy in the Prevention of Anastomotic Leak After Rectal Cancer Surgery
Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy
- Conditions
- Rectal Cancer
- Being tested
- transanal anastomotic reinforcement, protective ileostomy group, a circular anal dilator (CAD)
- Keywords
- colorectal anastomosis, anastomotic leak, ileostomy, complications
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transanal anastomotic reinforcementProcedure or surgery
a circular anal dilator (CAD) of 34mm in diameter will be introduced into the anus to facilitate the transanal introduction of the 29-31 circular stapler. The stapler shaft will be introduced trying to avoid the stapler line and connected with the anvil of the prepared proximal colon and then fired.
Patients selected on the TAR-LAR arm will have the stapled suture reinforced by 6 supplemental full thickness stitches in vycril 3/0 placed transanally with the aid of a semicircular valve introduced into the CAD (Epo Flier, SapiMed SPA, Alessandria, Italy), at hours 2-4-6-8-10-12.
protective ileostomy groupProcedure or surgery
S-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region.
a circular anal dilator (CAD)Device
Epo Flier, SapiMed SPA, Alessandria, Italy
| Study group | Role | What they receive |
|---|---|---|
| transanal anastomotic reinforcement | Active comparator | Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR) Receives: Procedure: transanal anastomotic reinforcement; Device: a circular anal dilator (CAD) |
| protective ileostomy group | Active comparator | Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR) Receives: Procedure: protective ileostomy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leak
anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis
Measured: 30 postoperative days
Secondary outcomes (2)
duration of the two operations
the duration in minutes of the two types of operation
Measured: Intraoperative
Number of overall postoperative complications
Measured: 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donato F Altomare
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Donato F Altomare, Societa Italiana di Chirurgia ColoRettale
- Investigators
- Arcangelo Picciariello, MD, Principal investigator, Societa Italiana di Chirurgia ColoRettale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279771
- Sponsor's protocol ID
- Siccr/2014
- Acronym
- LessStoReS
- Status last verified
- Jan 2022
- First submitted
- 29 Oct 2014
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Cong ZJ, Hu LH, Bian ZQ, Ye GY, Yu MH, Gao YH, Li ZS, Yu ED, Zhong M. Systematic review of anastomotic leakage rate according to an international grading system following anterior resection for rectal cancer. PLoS One. 2013 Sep 25;8(9):e75519. doi: 10.1371/journal.pone.0075519. eCollection 2013.
PubMed 24086552Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
PubMed 23335087Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.
PubMed 6751457Karanjia ND, Corder AP, Bearn P, Heald RJ. Leakage from stapled low anastomosis after total mesorectal excision for carcinoma of the rectum. Br J Surg. 1994 Aug;81(8):1224-6. doi: 10.1002/bjs.1800810850.
PubMed 7953369Fazio VW, Zutshi M, Remzi FH, Parc Y, Ruppert R, Furst A, Celebrezze J Jr, Galanduik S, Orangio G, Hyman N, Bokey L, Tiret E, Kirchdorfer B, Medich D, Tietze M, Hull T, Hammel J. A randomized multicenter trial to compare long-term functional outcome, quality of life, and complications of surgical procedures for low rectal cancers. Ann Surg. 2007 Sep;246(3):481-8; discussion 488-90. doi: 10.1097/SLA.0b013e3181485617.
PubMed 17717452Matthiessen P, Hallbook O, Andersson M, Rutegard J, Sjodahl R. Risk factors for anastomotic leakage after anterior resection of the rectum. Colorectal Dis. 2004 Nov;6(6):462-9. doi: 10.1111/j.1463-1318.2004.00657.x.
PubMed 15521937Gong JP, Yang L, Huang XE, Sun BC, Zhou JN, Yu DS, Zhou X, Li DZ, Guan X, Wang DF. Outcomes based on risk assessment of anastomotic leakage after rectal cancer surgery. Asian Pac J Cancer Prev. 2014;15(2):707-12. doi: 10.7314/apjcp.2014.15.2.707.
PubMed 24568483Rullier E, Laurent C, Garrelon JL, Michel P, Saric J, Parneix M. Risk factors for anastomotic leakage after resection of rectal cancer. Br J Surg. 1998 Mar;85(3):355-8. doi: 10.1046/j.1365-2168.1998.00615.x.
PubMed 9529492Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.
PubMed 21394013Branagan G, Finnis D; Wessex Colorectal Cancer Audit Working Group. Prognosis after anastomotic leakage in colorectal surgery. Dis Colon Rectum. 2005 May;48(5):1021-6. doi: 10.1007/s10350-004-0869-4.
PubMed 15789125Testini M, Gurrado A, Portincasa P, Scacco S, Marzullo A, Piccinni G, Lissidini G, Greco L, De Salvia MA, Bonfrate L, Debellis L, Sardaro N, Staffieri F, Carratu MR, Crovace A. Bovine pericardium patch wrapping intestinal anastomosis improves healing process and prevents leakage in a pig model. PLoS One. 2014 Jan 29;9(1):e86627. doi: 10.1371/journal.pone.0086627. eCollection 2014.
PubMed 24489752Baek SJ, Kim J, Kwak J, Kim SH. Can trans-anal reinforcing sutures after double stapling in lower anterior resection reduce the need for a temporary diverting ostomy? World J Gastroenterol. 2013 Aug 28;19(32):5309-13. doi: 10.3748/wjg.v19.i32.5309.
PubMed 23983434Senagore A, Lane FR, Lee E, Wexner S, Dujovny N, Sklow B, Rider P, Bonello J; Bioabsorbable Staple Line Reinforcement Study Group. Bioabsorbable staple line reinforcement in restorative proctectomy and anterior resection: a randomized study. Dis Colon Rectum. 2014 Mar;57(3):324-30. doi: 10.1097/DCR.0000000000000065.
PubMed 24509454Gastinger I, Marusch F, Steinert R, Wolff S, Koeckerling F, Lippert H; Working Group 'Colon/Rectum Carcinoma'. Protective defunctioning stoma in low anterior resection for rectal carcinoma. Br J Surg. 2005 Sep;92(9):1137-42. doi: 10.1002/bjs.5045.
PubMed 15997447Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.
PubMed 17667498
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial of Transanal Reinforcement of Low Rectal Anastomosis Versus Protective Ileostomy in the Prevention of Anastomotic Leak After Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT02279771
- Acronym / sponsor ID
- LessStoReS / Siccr/2014
- Conditions
- Rectal Cancer
- Keywords
- colorectal anastomosis, anastomotic leak, ileostomy, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Donato F AltomareResearch network
- Study start
- Jan 2015
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 Oct 2014 (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.
Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transanal anastomotic reinforcement | Active comparator | Procedure: transanal anastomotic reinforcement, Device: a circular anal dilator (CAD)Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR) |
| protective ileostomy group | Active comparator | Procedure: protective ileostomy groupStandard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Resectable, histologically proven primary adenocarcinoma of the medium-low rectum without internal and/or external sphincter muscle involvement.
- Distal margin of the tumor at least 6 cm form the anal verge
- Stage T2 - T4 at MRI N0-2 at MRI M0/M1 at CT scan Patient classified T3-T4 must undergo neoadjuvant chemoradiation with at least 8 weeks delay of surgery
Key exclusion criteria (10 listed)
- Squamous cell carcinoma
- Adenocarcinoma Stage T1,
- T4 with one of the following:
- with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total)
- Unresectable primary rectal cancer or Inability to complete R0 resection.
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 |
|---|---|---|
| transanal anastomotic reinforcementa circular anal dilator (CAD) of 34mm in diameter will be introduced into the anus to facilitate the transanal introduction of the 29-31 circular stapler. The stapler shaft will be introduced trying to avoid the stapler line and connected with the anvil of the prepared proximal colon and then fired. Patients selected on the TAR-LAR arm will have the stapled suture reinforced by 6 supplemental full thickness stitches in vycril 3/0 placed transanally with the aid of a semicircular valve introduced into the CAD (Epo Flier, SapiMed SPA, Alessandria, Italy), at hours 2-4-6-8-10-12. | Procedure or surgery | transanal anastomotic reinforcement |
| protective ileostomy groupS-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region. | Procedure or surgery | protective ileostomy group |
| a circular anal dilator (CAD)Epo Flier, SapiMed SPA, Alessandria, Italy | Device | transanal anastomotic reinforcement |
Primary outcome
anastomotic leak
Time frame: 30 postoperative days
anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis
2 secondary outcomes
duration of the two operations
Time frame: Intraoperative
Number of overall postoperative complications
Time frame: 30 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 24086552Cong ZJ, Hu LH, Bian ZQ, Ye GY, Yu MH, Gao YH, Li ZS, Yu ED, Zhong M. Systematic review of anastomotic leakage rate according to an international grading system following anterior resection for rectal cancer. PLoS One. 2013 Sep 25;8(9):e75519. doi: 10.1371/journal.pone.0075519. eCollection 2013.
- Background: PubMed 23335087Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
- Background: PubMed 6751457Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.
- Background: PubMed 7953369Karanjia ND, Corder AP, Bearn P, Heald RJ. Leakage from stapled low anastomosis after total mesorectal excision for carcinoma of the rectum. Br J Surg. 1994 Aug;81(8):1224-6. doi: 10.1002/bjs.1800810850.
- Background: PubMed 17717452Fazio VW, Zutshi M, Remzi FH, Parc Y, Ruppert R, Furst A, Celebrezze J Jr, Galanduik S, Orangio G, Hyman N, Bokey L, Tiret E, Kirchdorfer B, Medich D, Tietze M, Hull T, Hammel J. A randomized multicenter trial to compare long-term functional outcome, quality of life, and complications of surgical procedures for low rectal cancers. Ann Surg. 2007 Sep;246(3):481-8; discussion 488-90. doi: 10.1097/SLA.0b013e3181485617.
- Background: PubMed 15521937Matthiessen P, Hallbook O, Andersson M, Rutegard J, Sjodahl R. Risk factors for anastomotic leakage after anterior resection of the rectum. Colorectal Dis. 2004 Nov;6(6):462-9. doi: 10.1111/j.1463-1318.2004.00657.x.
- Background: PubMed 24568483Gong JP, Yang L, Huang XE, Sun BC, Zhou JN, Yu DS, Zhou X, Li DZ, Guan X, Wang DF. Outcomes based on risk assessment of anastomotic leakage after rectal cancer surgery. Asian Pac J Cancer Prev. 2014;15(2):707-12. doi: 10.7314/apjcp.2014.15.2.707.
- Background: PubMed 9529492Rullier E, Laurent C, Garrelon JL, Michel P, Saric J, Parneix M. Risk factors for anastomotic leakage after resection of rectal cancer. Br J Surg. 1998 Mar;85(3):355-8. doi: 10.1046/j.1365-2168.1998.00615.x.
- Background: PubMed 21394013Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.
- Background: PubMed 15789125Branagan G, Finnis D; Wessex Colorectal Cancer Audit Working Group. Prognosis after anastomotic leakage in colorectal surgery. Dis Colon Rectum. 2005 May;48(5):1021-6. doi: 10.1007/s10350-004-0869-4.
- Background: PubMed 24489752Testini M, Gurrado A, Portincasa P, Scacco S, Marzullo A, Piccinni G, Lissidini G, Greco L, De Salvia MA, Bonfrate L, Debellis L, Sardaro N, Staffieri F, Carratu MR, Crovace A. Bovine pericardium patch wrapping intestinal anastomosis improves healing process and prevents leakage in a pig model. PLoS One. 2014 Jan 29;9(1):e86627. doi: 10.1371/journal.pone.0086627. eCollection 2014.
- Background: PubMed 23983434Baek SJ, Kim J, Kwak J, Kim SH. Can trans-anal reinforcing sutures after double stapling in lower anterior resection reduce the need for a temporary diverting ostomy? World J Gastroenterol. 2013 Aug 28;19(32):5309-13. doi: 10.3748/wjg.v19.i32.5309.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Arcangelo Picciariello, MD principal investigator
Societa Italiana di Chirurgia ColoRettale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transanal anastomotic reinforcement, protective ileostomy group and a circular anal dilator (CAD) in people with Rectal Cancer, run by Donato F Altomare at 1 site in Italy.
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 11 Jan 2022. 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 Italy. 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 Donato F Altomare, MD (3397593066, donatofrancesco.altomare@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic leak (time frame: 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02279771, which also lists 21 linked publications.
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 11 Jan 2022.