Colorectal AnastomosisEAST-westNCT05544487
EAST-west Colorectal Study
An observational study of Colorectal Anastomosis, run by National and Kapodistrian University of Athens.
Trial summary
Colorectal resection due to benign and malignant diseases is a commonly performed procedure. The continuity of the gastrointestinal tract is re-established by creating an anastomosis. Although such procedures are often performed, anastomotic techniques and postoperative outcomes usually vary. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Colorectal Anastomosis
- What is being tested?
- Colorectal Anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Jun 2023
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients undergoing colorectal anastomoses due to benign or malignant reasons.
Who may be able to join
- Adults between 18-90 years old undergoing colorectal resection with anastomosis due to benign and malignant diseases
- Any of the procedures listed below performed as an emergency or elective surgery, and by any approach; open, laparoscopic or robotic:
- Right hemicolectomy and extended right hemicolectomy
- Ileocecal resection
- Transverse colon resection
- Segmental colonic resection - i.e. splenic resection
Show all 10Show fewer
- Left hemicolectomy
- Sigmoid resection
- Rectal resection
- Pan-proctocolectomy
Who cannot join
- Closure of ileostomy or colostomy
- Creation of multiple anastomoses
- Small bowel resection
- Pelvic exenteration
- Cytoreductive surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Preoperative Factors and Surgical Technique on Postoperative Outcomes in Patients Undergoing Colorectal Resections at South-eastern Europe.
Colorectal resection due to benign and malignant diseases is a commonly performed procedure. The continuity of the gastrointestinal tract is re-established by creating an anastomosis. Although such procedures are often performed, anastomotic techniques and postoperative outcomes usually vary. Failure of the anastomosis might be a life-threatening condition after colorectal resection. A relatively high incidence of anastomotic leaks (up to 30%) has been reported worldwide. Anastomotic failure could happen due to several reasons, that are divided into surgeon-related factors and patient-related factors. So far, there has been no data about the incidence of anastomotic leak in the Western Balkans and the Mediterranean countries.The aim of EAST-WEST Colorectal Study 2022 is to investigate differences in patients undergoing colorectal resections, including pre-operative patient preparation, history of prior surgeries and anastomotic techniques. In addition, this study aims to collect data about post-operative complication rate within 30 days post-surgery across Balkan countries (Slovenia, Serbia, Macedonia, Croatia, BIH and Monte Negro), Greece, Romania and Malta, hence the study outcomes could be applicable to the Mediterranean region, in which patients share a common set of characteristics. This would enable variabilities in practice to be identified and differences regarding postoperative outcomes to be highlighted.
- Conditions
- Colorectal Anastomosis
- Being tested
- Colorectal Anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal AnastomosisProcedure or surgery
Differences in intra-operative techniques and surgeon grades
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage rate
Measured: 30 days
Secondary outcomes (5)
Re-admission rate within the first 30 days post-surgery.
Measured: 30 days
30-day postoperative morbidity
Measured: 30 days
30-day postoperative mortality
Measured: 30 days
Clavien-Dindo complication classification
Measured: 30 days
Length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AnastomosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Theodoropoulos, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544487
- Sponsor's protocol ID
- EAST-west 2022
- Acronym
- EAST-west
- Status last verified
- Oct 2022
- First submitted
- 10 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Factors and Surgical Technique on Postoperative Outcomes in Patients Undergoing Colorectal Resections at South-eastern Europe.
- ClinicalTrials.gov ID
- NCT05544487
- Acronym / sponsor ID
- EAST-west / EAST-west 2022
- Conditions
- Colorectal Anastomosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 16 Sep 2022 (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.
Colorectal resection due to benign and malignant diseases is a commonly performed procedure. The continuity of the gastrointestinal tract is re-established by creating an anastomosis. Although such procedures are often performed, anastomotic techniques and postoperative outcomes usually vary. Failure of the anastomosis might be a life-threatening condition after colorectal resection. A relatively high incidence of anastomotic leaks (up to 30%) has been reported worldwide. Anastomotic failure could happen due to several reasons, that are divided into surgeon-related factors and patient-related factors. So far, there has been no data about the incidence of anastomotic leak in the Western Balkans and the Mediterranean countries.The aim of EAST-WEST Colorectal Study 2022 is to investigate differences in patients undergoing colorectal resections, including pre-operative patient preparation, history of prior surgeries and anastomotic techniques. In addition, this study aims to collect data about post-operative complication rate within 30 days post-surgery across Balkan countries (Slovenia, Serbia, Macedonia, Croatia, BIH and Monte Negro), Greece, Romania and Malta, hence the study outcomes could be applicable to the Mediterranean region, in which patients share a common set of characteristics. This would enable variabilities in practice to be identified and differences regarding postoperative outcomes to be highlighted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients undergoing colorectal anastomoses due to benign or malignant reasons.
Key inclusion criteria (10 listed)
- Adults between 18-90 years old undergoing colorectal resection with anastomosis due to benign and malignant diseases
- Any of the procedures listed below performed as an emergency or elective surgery, and by any approach; open, laparoscopic or robotic:
Key exclusion criteria (5 listed)
- Closure of ileostomy or colostomy
- Creation of multiple anastomoses
- Small bowel resection
- Pelvic exenteration
- Cytoreductive surgery
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 |
|---|---|---|
| Colorectal AnastomosisDifferences in intra-operative techniques and surgeon grades | Procedure or surgery | – |
Primary outcome
Leakage rate
Time frame: 30 days
5 secondary outcomes
Re-admission rate within the first 30 days post-surgery.
Time frame: 30 days
30-day postoperative morbidity
Time frame: 30 days
30-day postoperative mortality
Time frame: 30 days
Clavien-Dindo complication classification
Time frame: 30 days
Length of stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Anastomosis, run by National and Kapodistrian University of Athens.
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 10 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 10 Oct 2022. 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?
Contact Maximos Frountzas, PhD (+0030 6978880045, froumax@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leakage rate (time frame: 30 days). 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 10 Oct 2022.