Anastomotic LeakNCT04553250
Lateral Invagination of the Colorectal Anastomosis by Double Stapling
A study testing Doubled-stapled colorectal anastomosis in people with Anastomotic Leak and Sigmoid Diseases, run by Hospital Clinic of Barcelona.
Trial summary
Anastomotic dehiscence is the most feared complication in colorectal surgery, occurring in 6.3% -13.7% in patients with pelvic anastomoses [1-4]. This complication significantly increases morbidity, mortality, costs, and generates a greater impact on quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anastomotic Leak, Sigmoid Diseases
- What is being tested?
- Doubled-stapled colorectal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 786 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Jan 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age> 18 years
- Indication of resection of the left colon, sigmoid or upper rectum
- Minimally invasive approach
- Open surgery approach
- Double staple colorectal anastomosis
- Signed informed consent for inclusion in the study
Who cannot join
- Patients <18 years
- Pregnancy
- ASA> III
- Absolute contraindication for anesthesia
- Patients who receive more than 1 gastrointestinal anastomosis during the same procedure
- Planned multi-organ resection during the same procedure
Show all 10Show fewer
- Urgent / emergent surgery
- Reinforced anastomosis after positive intraoperative leak test
- Patients with simultaneous application of debulking and HIPEC
- Crohn's disease or active ulcerative colitis
About this study
Official title: Randomized Controlled Clinical Trial on Lateral Invagination of the Colorectal Anastomosis by Double Stapling
Anastomotic dehiscence is the most feared complication in colorectal surgery, occurring in 6.3% -13.7% in patients with pelvic anastomoses [1-4]. This complication significantly increases morbidity, mortality, costs, and generates a greater impact on quality of life. In addition, several studies point to an increased risk of locoregional recurrence [5, 6].
There are different risk factors for anastomotic dehiscence: some preoperative, such as malnutrition or obesity [9]; other intraoperative ones, such as hypoperfusion of the anastomotic tissue or the anastomotic technique; and others postoperative, such as some types of medication [7]. In colorectal anastomoses, there is some concern about the safety of the double stapling technique, since the extremes of the linear suture line (called "dog ears") and the number of staple lines have a direct relationship with the risk of dehiscence [8-11].
With the aim of reducing suture dehiscence rates, different intraoperative techniques have been developed, such as reinforcing the anastomosis with stitches, the use of indocyanine green [12, 13] or the application of anastomotic sealants [14], without finding a definitive solution. Recently, benefits have been published of using the double-staple colorectal anastomosis lateral invagination technique, with the aim of avoiding "dog ears" [15-17]. Several case series and retrospective comparative studies have shown a significant decrease in anastomotic dehiscence using this technique, with all the clinical and economic benefits that this entails [15-17]. In this sense, the present study aims to evaluate the effectiveness and safety of the lateral invagination technique of double-staple colorectal anastomosis in a randomized and controlled trial.
- Conditions
- Anastomotic Leak, Sigmoid Diseases
- Being tested
- Doubled-stapled colorectal anastomosis
- Keywords
- anastomotic leak, doubled-stapled anastomosis
- Medical subject headings
- Anastomotic Leak, Sigmoid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doubled-stapled colorectal anastomosisProcedure or surgery
Anastomosis performed between the colon an the rectal stump, using a double-stapled technique.
| Study group | Role | What they receive |
|---|---|---|
| Conventional technique | Active comparator | In this group, double-staple colorectal anastomosis will be performed following the technique described by Lee et al: Prior to firing the endostapler, a suture will be placed on the rectal stump that includes both "dog ears". After the punch comes out of the endostapler, the point will be tied, which will invaginate the two corners of the staple line on the same punch. Subsequently, the endostapler will be closed and fired, including the "dog ears" in the anastomotic rims Receives: Procedure: Doubled-stapled colorectal anastomosis |
| Lateral invagination technique | Active comparator | In this group, the circular endostapler will be fired in a conventional way, that is, without having invaginated the two corners of the staple line. Receives: Procedure: Doubled-stapled colorectal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days
anastomotic dehiscence diagnosis
Measured: 30 days
Secondary outcomes (8)
Duration of surgery
Measured: 1 day
Rate of perioperative morbidity using the Clavien-Dindo classification.
Measured: 30 and 90 days PO or in-hospital stay
Rate of perioperative mortality
Measured: 30 and 90 days PO or in-hospital stay
Duration of hospital stay
Measured: days
Rate of hospital readmissions
Measured: 30 days
Rate of surgical reinterventions
Measured: 30 days
Rate Stoma closure
Measured: 1 year
Rate of Stoma-free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 786 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio M Lacy, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553250
- Sponsor's protocol ID
- HCB/2020/1057
- Status last verified
- Feb 2021
- First submitted
- 11 Sep 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang CY, Halabi WJ, Chaudhry OO, Nguyen V, Pigazzi A, Carmichael JC, Mills S, Stamos MJ. Risk factors for anastomotic leakage after anterior resection for rectal cancer. JAMA Surg. 2013 Jan;148(1):65-71. doi: 10.1001/2013.jamasurg.2.
PubMed 22986932den Dulk M, Marijnen CA, Collette L, Putter H, Pahlman L, Folkesson J, Bosset JF, Rodel C, Bujko K, van de Velde CJ. Multicentre analysis of oncological and survival outcomes following anastomotic leakage after rectal cancer surgery. Br J Surg. 2009 Sep;96(9):1066-75. doi: 10.1002/bjs.6694.
PubMed 19672927Peeters KC, Tollenaar RA, Marijnen CA, Klein Kranenbarg E, Steup WH, Wiggers T, Rutten HJ, van de Velde CJ; Dutch Colorectal Cancer Group. Risk factors for anastomotic failure after total mesorectal excision of rectal cancer. Br J Surg. 2005 Feb;92(2):211-6. doi: 10.1002/bjs.4806.
PubMed 15584062Paun BC, Cassie S, MacLean AR, Dixon E, Buie WD. Postoperative complications following surgery for rectal cancer. Ann Surg. 2010 May;251(5):807-18. doi: 10.1097/SLA.0b013e3181dae4ed.
PubMed 20395841Senagore 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 24509454Kingham TP, Pachter HL. Colonic anastomotic leak: risk factors, diagnosis, and treatment. J Am Coll Surg. 2009 Feb;208(2):269-78. doi: 10.1016/j.jamcollsurg.2008.10.015. Epub 2008 Dec 4. No abstract available.
PubMed 19228539Gorissen KJ, Benning D, Berghmans T, Snoeijs MG, Sosef MN, Hulsewe KW, Luyer MD. Risk of anastomotic leakage with non-steroidal anti-inflammatory drugs in colorectal surgery. Br J Surg. 2012 May;99(5):721-7. doi: 10.1002/bjs.8691. Epub 2012 Feb 9.
PubMed 22318712Ito M, Sugito M, Kobayashi A, Nishizawa Y, Tsunoda Y, Saito N. Relationship between multiple numbers of stapler firings during rectal division and anastomotic leakage after laparoscopic rectal resection. Int J Colorectal Dis. 2008 Jul;23(7):703-7. doi: 10.1007/s00384-008-0470-8. Epub 2008 Apr 1.
PubMed 18379795Kim JS, Cho SY, Min BS, Kim NK. Risk factors for anastomotic leakage after laparoscopic intracorporeal colorectal anastomosis with a double stapling technique. J Am Coll Surg. 2009 Dec;209(6):694-701. doi: 10.1016/j.jamcollsurg.2009.09.021.
PubMed 19959036Park JS, Choi GS, Kim SH, Kim HR, Kim NK, Lee KY, Kang SB, Kim JY, Lee KY, Kim BC, Bae BN, Son GM, Lee SI, Kang H. Multicenter analysis of risk factors for anastomotic leakage after laparoscopic rectal cancer excision: the Korean laparoscopic colorectal surgery study group. Ann Surg. 2013 Apr;257(4):665-71. doi: 10.1097/SLA.0b013e31827b8ed9.
PubMed 23333881Kawada K, Hasegawa S, Hida K, Hirai K, Okoshi K, Nomura A, Kawamura J, Nagayama S, Sakai Y. Risk factors for anastomotic leakage after laparoscopic low anterior resection with DST anastomosis. Surg Endosc. 2014 Oct;28(10):2988-95. doi: 10.1007/s00464-014-3564-0. Epub 2014 May 23.
PubMed 24853855Boni L, David G, Dionigi G, Rausei S, Cassinotti E, Fingerhut A. Indocyanine green-enhanced fluorescence to assess bowel perfusion during laparoscopic colorectal resection. Surg Endosc. 2016 Jul;30(7):2736-42. doi: 10.1007/s00464-015-4540-z. Epub 2015 Oct 20.
PubMed 26487209James DR, Ris F, Yeung TM, Kraus R, Buchs NC, Mortensen NJ, Hompes RJ. Fluorescence angiography in laparoscopic low rectal and anorectal anastomoses with pinpoint perfusion imaging--a critical appraisal with specific focus on leak risk reduction. Colorectal Dis. 2015 Oct;17 Suppl 3:16-21. doi: 10.1111/codi.13033.
PubMed 26394738Stergios K, Kontzoglou K, Pergialiotis V, Korou LM, Frountzas M, Lalude O, Nikiteas N, Perrea DN. The potential effect of biological sealants on colorectal anastomosis healing in experimental research involving severe diabetes. Ann R Coll Surg Engl. 2017 Mar;99(3):189-192. doi: 10.1308/rcsann.2016.0357. Epub 2016 Dec 5.
PubMed 27917665Lee S, Ahn B, Lee S. The Relationship Between the Number of Intersections of Staple Lines and Anastomotic Leakage After the Use of a Double Stapling Technique in Laparoscopic Colorectal Surgery. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):273-281. doi: 10.1097/SLE.0000000000000422.
PubMed 28614172
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial on Lateral Invagination of the Colorectal Anastomosis by Double Stapling
- ClinicalTrials.gov ID
- NCT04553250
- Acronym / sponsor ID
- HCB/2020/1057
- Conditions
- Anastomotic Leak, Sigmoid Diseases
- Keywords
- anastomotic leak, doubled-stapled anastomosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 786 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 17 Sep 2020 (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.
Anastomotic dehiscence is the most feared complication in colorectal surgery, occurring in 6.3% -13.7% in patients with pelvic anastomoses [1-4]. This complication significantly increases morbidity, mortality, costs, and generates a greater impact on quality of life. In addition, several studies point to an increased risk of locoregional recurrence [5, 6].
There are different risk factors for anastomotic dehiscence: some preoperative, such as malnutrition or obesity [9]; other intraoperative ones, such as hypoperfusion of the anastomotic tissue or the anastomotic technique; and others postoperative, such as some types of medication [7]. In colorectal anastomoses, there is some concern about the safety of the double stapling technique, since the extremes of the linear suture line (called "dog ears") and the number of staple lines have a direct relationship with the risk of dehiscence [8-11].
With the aim of reducing suture dehiscence rates, different intraoperative techniques have been developed, such as reinforcing the anastomosis with stitches, the use of indocyanine green [12, 13] or the application of anastomotic sealants [14], without finding a definitive solution. Recently, benefits have been published of using the double-staple colorectal anastomosis lateral invagination technique, with the aim of avoiding "dog ears" [15-17]. Several case series and retrospective comparative studies have shown a significant decrease in anastomotic dehiscence using this technique, with all the clinical and economic benefits that this entails [15-17]. In this sense, the present study aims to evaluate the effectiveness and safety of the lateral invagination technique of double-staple colorectal anastomosis in a randomized and controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional technique | Active comparator | Procedure: Doubled-stapled colorectal anastomosisIn this group, double-staple colorectal anastomosis will be performed following the technique described by Lee et al: Prior to firing the endostapler, a suture will be placed on the rectal stump that includes both "dog ears". After the punch comes out of the endostapler, the point will be tied, which will invaginate the two corners of the staple line on the same punch. Subsequently, the endostapler will be closed and fired, including the "dog ears" in the anastomotic rims |
| Lateral invagination technique | Active comparator | Procedure: Doubled-stapled colorectal anastomosisIn this group, the circular endostapler will be fired in a conventional way, that is, without having invaginated the two corners of the staple line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age> 18 years
- Indication of resection of the left colon, sigmoid or upper rectum
- Minimally invasive approach
- Open surgery approach
- Double staple colorectal anastomosis
Key exclusion criteria (10 listed)
- Patients <18 years
- Pregnancy
- ASA> III
- Absolute contraindication for anesthesia
- Patients who receive more than 1 gastrointestinal anastomosis during the same procedure
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 |
|---|---|---|
| Doubled-stapled colorectal anastomosisAnastomosis performed between the colon an the rectal stump, using a double-stapled technique. | Procedure or surgery | Conventional technique, Lateral invagination technique |
Primary outcome
Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days
Time frame: 30 days
anastomotic dehiscence diagnosis
8 secondary outcomes
Duration of surgery
Time frame: 1 day
Rate of perioperative morbidity using the Clavien-Dindo classification.
Time frame: 30 and 90 days PO or in-hospital stay
Rate of perioperative mortality
Time frame: 30 and 90 days PO or in-hospital stay
Duration of hospital stay
Time frame: days
Rate of hospital readmissions
Time frame: 30 days
Rate of surgical reinterventions
Time frame: 30 days
Rate Stoma closure
Time frame: 1 year
Rate of Stoma-free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 22986932Kang CY, Halabi WJ, Chaudhry OO, Nguyen V, Pigazzi A, Carmichael JC, Mills S, Stamos MJ. Risk factors for anastomotic leakage after anterior resection for rectal cancer. JAMA Surg. 2013 Jan;148(1):65-71. doi: 10.1001/2013.jamasurg.2.
- Background: PubMed 19672927den Dulk M, Marijnen CA, Collette L, Putter H, Pahlman L, Folkesson J, Bosset JF, Rodel C, Bujko K, van de Velde CJ. Multicentre analysis of oncological and survival outcomes following anastomotic leakage after rectal cancer surgery. Br J Surg. 2009 Sep;96(9):1066-75. doi: 10.1002/bjs.6694.
- Background: PubMed 15584062Peeters KC, Tollenaar RA, Marijnen CA, Klein Kranenbarg E, Steup WH, Wiggers T, Rutten HJ, van de Velde CJ; Dutch Colorectal Cancer Group. Risk factors for anastomotic failure after total mesorectal excision of rectal cancer. Br J Surg. 2005 Feb;92(2):211-6. doi: 10.1002/bjs.4806.
- Background: PubMed 20395841Paun BC, Cassie S, MacLean AR, Dixon E, Buie WD. Postoperative complications following surgery for rectal cancer. Ann Surg. 2010 May;251(5):807-18. doi: 10.1097/SLA.0b013e3181dae4ed.
- Background: PubMed 24509454Senagore 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.
- Background: PubMed 19228539Kingham TP, Pachter HL. Colonic anastomotic leak: risk factors, diagnosis, and treatment. J Am Coll Surg. 2009 Feb;208(2):269-78. doi: 10.1016/j.jamcollsurg.2008.10.015. Epub 2008 Dec 4. No abstract available.
- Background: PubMed 22318712Gorissen KJ, Benning D, Berghmans T, Snoeijs MG, Sosef MN, Hulsewe KW, Luyer MD. Risk of anastomotic leakage with non-steroidal anti-inflammatory drugs in colorectal surgery. Br J Surg. 2012 May;99(5):721-7. doi: 10.1002/bjs.8691. Epub 2012 Feb 9.
- Background: PubMed 18379795Ito M, Sugito M, Kobayashi A, Nishizawa Y, Tsunoda Y, Saito N. Relationship between multiple numbers of stapler firings during rectal division and anastomotic leakage after laparoscopic rectal resection. Int J Colorectal Dis. 2008 Jul;23(7):703-7. doi: 10.1007/s00384-008-0470-8. Epub 2008 Apr 1.
- Background: PubMed 19959036Kim JS, Cho SY, Min BS, Kim NK. Risk factors for anastomotic leakage after laparoscopic intracorporeal colorectal anastomosis with a double stapling technique. J Am Coll Surg. 2009 Dec;209(6):694-701. doi: 10.1016/j.jamcollsurg.2009.09.021.
- Background: PubMed 23333881Park JS, Choi GS, Kim SH, Kim HR, Kim NK, Lee KY, Kang SB, Kim JY, Lee KY, Kim BC, Bae BN, Son GM, Lee SI, Kang H. Multicenter analysis of risk factors for anastomotic leakage after laparoscopic rectal cancer excision: the Korean laparoscopic colorectal surgery study group. Ann Surg. 2013 Apr;257(4):665-71. doi: 10.1097/SLA.0b013e31827b8ed9.
- Background: PubMed 24853855Kawada K, Hasegawa S, Hida K, Hirai K, Okoshi K, Nomura A, Kawamura J, Nagayama S, Sakai Y. Risk factors for anastomotic leakage after laparoscopic low anterior resection with DST anastomosis. Surg Endosc. 2014 Oct;28(10):2988-95. doi: 10.1007/s00464-014-3564-0. Epub 2014 May 23.
- Background: PubMed 26487209Boni L, David G, Dionigi G, Rausei S, Cassinotti E, Fingerhut A. Indocyanine green-enhanced fluorescence to assess bowel perfusion during laparoscopic colorectal resection. Surg Endosc. 2016 Jul;30(7):2736-42. doi: 10.1007/s00464-015-4540-z. Epub 2015 Oct 20.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Doubled-stapled colorectal anastomosis in people with Anastomotic Leak and Sigmoid Diseases, run by Hospital Clinic of Barcelona.
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 6 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days (time frame: 30 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 NCT04553250, which also lists 20 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 10 Feb 2021.