Continuous or Interrupted SutureNCT02658643
Analysis of Biliodigestive Anastomosis Techniques (BDA)
A study testing Continuous suture technique and Interrupted suture technique in people with Continuous or Interrupted Suture, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous or Interrupted Suture
- What is being tested?
- Continuous suture technique and Interrupted suture technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jan 2016to 17 Sep 2019
- 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
- Patients over 18 years of age
- Scheduled for elective BDA procedure
- Primary BDA procedure
- Diameter of DHC > 7mm
- Written consent
Who cannot join
- Previous BDA procedure
- Impaired mental state or language problems
- Lacking compliance
- Emergency procedure
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
Dresden
About this study
Official title: Randomized Controlled Study to Determine the Difference in Time and Complication Rate for Biliodigestive Anastomosis by Continuous Versus Interrupted Suture Technique
The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture.
Read the detailed description
The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture. A biliodigestive anastomosis is a surgical connection between the common bile duct (ductus choledochus) and the digestive tract to prevent interference of bile flow. Indications for a biliodigestive anastomosis include total or partial resection of the pancreas and duodenum (PPPD, Whipple procedure) for pancreatic tumors, tumors of the biliary tract or duodenum, and biliary tract reconstructions during liver transplantation or advanced liver resections. Furthermore a biliodigestive anastomosis can be required to manage the injury of the biliary tract and infectious and traumatic structures of the biliary tract. Biliodigestive anastomoses can be performed by continuous or interrupted suture. The aim of this study is to determine the difference between continuous and interrupted suture for biliodigestive anastomoses, as advantages and disadvantages of each technique have not been determined. Only patients receiving their first biliodigestive anastomosis will be included.
- Conditions
- Continuous or Interrupted Suture
- Being tested
- Continuous suture technique, Interrupted suture technique
- Keywords
- biliodigestive anastomosis techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous suture techniqueProcedure or surgery
The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis
Interrupted suture techniqueProcedure or surgery
The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Continuous suture technique | Experimental | The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis Receives: Procedure: Continuous suture technique |
| Interrupted suture technique | Active comparator | The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis Receives: Procedure: Interrupted suture technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete the biliodigestive anastomosis
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start20 Jan 2016
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Continuous or Interrupted SutureStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Reißfelder, MD, Principal investigator, christoph.reissfelder@uniklinikum-dresden.de
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658643
- Sponsor's protocol ID
- VTG-06
- Status last verified
- Oct 2019
- First submitted
- 15 Jan 2016
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seifert L, von Renesse J, Seifert AM, Sturm D, Meisterfeld R, Rahbari NN, Kahlert C, Distler M, Weitz J, Reissfelder C. Interrupted versus continuous suture technique for biliary-enteric anastomosis: randomized clinical trial. BJS Open. 2023 Jan 6;7(1):zrac163. doi: 10.1093/bjsopen/zrac163.
PubMed 36723996
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study to Determine the Difference in Time and Complication Rate for Biliodigestive Anastomosis by Continuous Versus Interrupted Suture Technique
- ClinicalTrials.gov ID
- NCT02658643
- Acronym / sponsor ID
- VTG-06
- Conditions
- Continuous or Interrupted Suture
- Keywords
- biliodigestive anastomosis techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 20 Jan 2016 (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.
The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture.
Detailed description
The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture. A biliodigestive anastomosis is a surgical connection between the common bile duct (ductus choledochus) and the digestive tract to prevent interference of bile flow. Indications for a biliodigestive anastomosis include total or partial resection of the pancreas and duodenum (PPPD, Whipple procedure) for pancreatic tumors, tumors of the biliary tract or duodenum, and biliary tract reconstructions during liver transplantation or advanced liver resections. Furthermore a biliodigestive anastomosis can be required to manage the injury of the biliary tract and infectious and traumatic structures of the biliary tract. Biliodigestive anastomoses can be performed by continuous or interrupted suture. The aim of this study is to determine the difference between continuous and interrupted suture for biliodigestive anastomoses, as advantages and disadvantages of each technique have not been determined. Only patients receiving their first biliodigestive anastomosis will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous suture technique | Experimental | Procedure: Continuous suture techniqueThe BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis |
| Interrupted suture technique | Active comparator | Procedure: Interrupted suture techniqueThe BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18 years of age
- Scheduled for elective BDA procedure
- Primary BDA procedure
- Diameter of DHC > 7mm
- Written consent
Key exclusion criteria (4 listed)
- Previous BDA procedure
- Impaired mental state or language problems
- Lacking compliance
- Emergency 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 |
|---|---|---|
| Continuous suture techniqueThe BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis | Procedure or surgery | Continuous suture technique |
| Interrupted suture techniqueThe BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis | Procedure or surgery | Interrupted suture technique |
Primary outcome
Time to complete the biliodigestive anastomosis
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Derived from this study: PubMed 36723996Seifert L, von Renesse J, Seifert AM, Sturm D, Meisterfeld R, Rahbari NN, Kahlert C, Distler M, Weitz J, Reissfelder C. Interrupted versus continuous suture technique for biliary-enteric anastomosis: randomized clinical trial. BJS Open. 2023 Jan 6;7(1):zrac163. doi: 10.1093/bjsopen/zrac163.
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.
Christoph Reißfelder, MD principal investigator
christoph.reissfelder@uniklinikum-dresden.de
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous suture technique and Interrupted suture technique in people with Continuous or Interrupted Suture, run by Technische Universität Dresden 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to complete the biliodigestive anastomosis (time frame: 30 minutes). 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 NCT02658643, which also lists 1 linked publication.
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 22 Oct 2019.