Anastomosis, LeakingDULKNCT06733571
Assessing the Validity of Dulk Score in Identifying Anastomotic Leak in Early Postoperative Period
An observational study of Anastomosis, Leaking, run by Sawai Mansingh Medical College at 1 site in India.
Trial summary
Anastomotic leak is a commonly seen post-operative complication in patients who undergo bowel anastomosis. The outcome of which can range from conservative management to re-exteriorisation of bowel loop. This apart from financial distress can cause psychological impact on patient and his/her family. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomosis, Leaking
- How many people
- 86 participants
- Where
- 1 siteIndia
- Study dates
- 22 Mar 2023to 12 May 2024
- How long will I take part?
- 12 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study focused on patients undergoing elective intestinal anastomosis procedures at the Department of Surgery, SMS Medical College in Jaipur. These procedures included jejuno-jejunal, ileo-ileal anastomoses, ileo-colic and colo-colic anastomoses, as well as stoma closure. Prior to the surgeries, written informed consent was obtained from the patients. By specifically examining these elective procedures involving various types of anastomoses and stoma closure, the study aimed to investigate and analyse outcomes related to these surgical interventions within the clinical setting of the SMS Medical College in Jaipur.
Inclusion Criteria:1. Patients who provided informed consent to participate in the study.
- Patients aged 18 years or older. 3. Patients who underwent elective intestinal anastomosis in a planned operation (elective OT).
- Patients with a single-site intestinal anastomosis.
-
Exclusion Criteria:1. Patients operated on in an emergency setting. 2. Patients who underwent anastomosis at multiple sites (e.g., multiple bowel resections, whipples operation).
- Patients lost to follow-up during the post-operative period. 4. Patients who were unable or unwilling to provide informed consent. 5. Pregnant or breastfeeding women, as the study interventions may not be suitable during these periods.
- Patients with significant cognitive impairments or psychiatric disorders that would limit their ability to understand the study protocol or provide informed consent.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study on Validity of DULK Score as a Tool for Early Diagnosis of Anastomotic Leakage in the Immediate Post-Operative Period After Elective Primary Intestinal Anastomosis
Anastomotic leak is a commonly seen post-operative complication in patients who undergo bowel anastomosis. The outcome of which can range from conservative management to re-exteriorisation of bowel loop. This apart from financial distress can cause psychological impact on patient and his/her family. Understanding the risk factors identified, such as age, chronic diseases, anemia, and surgical variables, can aid healthcare providers in risk assessment, preoperative optimization, and postoperative monitoring to reduce the occurrence of anastomotic leaks.
By implementing strategies to address these risk factors, healthcare systems can improve patient outcomes, reduce complications, and enhance the quality of care provided to individuals undergoing surgical procedures, ultimately contributing to better public health outcomes and healthcare resource utilization.
Read the detailed description
Study Population This study was conducted on a cohort of 86 patients who underwent elective open intestinal anastomosis at SMS Medical College, Jaipur. The patient population consisted of 48 males (59%) and 38 females (41%). The average age of the participants was 42.68 years, with a broad age range that allowed for the analysis of age-related risk factors in relation to anastomotic leaks (AL).
Risk Factors Considered for Anastomotic Leaks (AL)
Age and Gender:
The study explored the relationship between age and the incidence of anastomotic leaks, particularly focusing on age groups above 60 years. Gender-related patterns were also assessed.
Chronic Diseases:
Patients with chronic conditions such as diabetes mellitus, hypertension, and malignancy were included to assess their role in the development of anastomotic leaks.
Immunocompromised Status:
Patients with compromised immune systems, including those undergoing chemotherapy or immunosuppressive therapy, were considered in the study.
Chronic Steroid Use:
The impact of chronic steroid use on anastomotic leak rates was evaluated.
Anemia and Hypoalbuminemia:
The study assessed anemia (hemoglobin levels <10 g/dL) and hypoalbuminemia (serum albumin levels <3 g/dL) as potential risk factors for anastomotic leaks.
Leukocytosis:
Leukocytosis (elevated white blood cell count) was also examined as a risk factor.
Surgical Factors Considered
Surgical Technique:
The study evaluated whether the type of surgical technique (hand-sewn vs. stapled anastomosis) influenced the occurrence of anastomotic leaks.
Location of Anastomosis:
The effect of the location of the anastomosis (e.g., distal vs. proximal) on the risk of leaks was considered.
Duration of Surgery:
The study examined whether longer surgeries (lasting over 4 hours) were associated with a higher incidence of leaks.
Surgeon Experience:
The impact of surgeon experience on leak rates was considered, focusing on procedures performed by residents versus consultants.
DULK Score and Leak Detection The DULK score, a clinical scoring system, was used in the study to predict the likelihood of an anastomotic leak in the early postoperative period. Its role in identifying high-risk patients was an important aspect of the study.
- Conditions
- Anastomosis, Leaking
- Keywords
- ANASTOTIC LEAK, DULK SCORE, DULK SCORE, LEAK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing elective intestinal anastomosis procedures | The SMS Medical College Elective Intestinal Anastomosis Cohort is a prospective cohort study that includes patients undergoing elective intestinal anastomosis procedures at the Department of Surgery, SMS Medical College, Jaipur. This cohort consists of 86 patients who underwent various types of elective bowel reconnection surgeries, including jejuno-jejunal, ileo-ileal, ileo-colic, and colo-colic anastomoses, as well as stoma closures, between [study period]. The cohort includes both male and female patients aged 18 years and older who provided informed consent to participate. The primary aim of this cohort study is to assess the incidence and risk factors of anastomotic leaks (AL)-a serious postoperative complication that can significantly impact patient outcomes. Detailed monitoring of preoperative conditions, surgical factors, and postoperative outcomes, the study aims to identify key risk factors associated with AL, including patient comorbidities |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANASTOMOTIC LEAK
The primary outcome measure is the incidence of anastomotic leaks (AL) in patients who undergo elective intestinal anastomosis at SMS Medical College, Jaipur. AL is defined as the failure of the bowel anastomosis to properly heal, leading to the leakage of intestinal contents into the peritoneal cavity, which may result in peritonitis or sepsis. The incidence is assessed in the postoperative period, primarily within the first 12 days following surgery.
Measured: 12 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start22 Mar 2023
- Primary completion23 Apr 2024
- Study completion12 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomosis, LeakingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
- Target duration
- 12 Days
Sponsor and investigators
- Lead sponsor
- Sawai Mansingh Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DARSHAN KUMAR RATHOR, Sawai Mansingh Medical College
- Investigators
- Dr Prabha OM, Study chair, HOD DEPT OF GENERAL SURGERY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733571
- Sponsor's protocol ID
- SawaiMansinghMC
- Other IDs
- INSTITUTE
- Acronym
- DULK
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this stage, the decision regarding whether to share individual participant data (IPD) with other researchers has not been finalized. We are currently evaluating the ethical, legal, and logistical considerations surrounding data sharing, including patient privacy, consent, and institutional guidelines. The primary goal is to ensure that any data shared respects participant confidentiality and complies with relevant regulations. If the decision is made to share the data, it will be made available through a secure platform, with proper oversight and approval from the relevant ethics committees. Further details will be provided once the final decision is made.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on Validity of DULK Score as a Tool for Early Diagnosis of Anastomotic Leakage in the Immediate Post-Operative Period After Elective Primary Intestinal Anastomosis
- ClinicalTrials.gov ID
- NCT06733571
- Acronym / sponsor ID
- DULK / SawaiMansinghMC
- Conditions
- Anastomosis, Leaking
- Keywords
- ANASTOTIC LEAK, DULK SCORE, DULK SCORE, LEAK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Sawai Mansingh Medical CollegeOther government
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 12 May 2024 (actual)
- First posted
- 13 Dec 2024 (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 leak is a commonly seen post-operative complication in patients who undergo bowel anastomosis. The outcome of which can range from conservative management to re-exteriorisation of bowel loop. This apart from financial distress can cause psychological impact on patient and his/her family. Understanding the risk factors identified, such as age, chronic diseases, anemia, and surgical variables, can aid healthcare providers in risk assessment, preoperative optimization, and postoperative monitoring to reduce the occurrence of anastomotic leaks.
By implementing strategies to address these risk factors, healthcare systems can improve patient outcomes, reduce complications, and enhance the quality of care provided to individuals undergoing surgical procedures, ultimately contributing to better public health outcomes and healthcare resource utilization.
Detailed description
Study Population This study was conducted on a cohort of 86 patients who underwent elective open intestinal anastomosis at SMS Medical College, Jaipur. The patient population consisted of 48 males (59%) and 38 females (41%). The average age of the participants was 42.68 years, with a broad age range that allowed for the analysis of age-related risk factors in relation to anastomotic leaks (AL).
Risk Factors Considered for Anastomotic Leaks (AL)
Age and Gender:
The study explored the relationship between age and the incidence of anastomotic leaks, particularly focusing on age groups above 60 years. Gender-related patterns were also assessed.
Chronic Diseases:
Patients with chronic conditions such as diabetes mellitus, hypertension, and malignancy were included to assess their role in the development of anastomotic leaks.
Immunocompromised Status:
Patients with compromised immune systems, including those undergoing chemotherapy or immunosuppressive therapy, were considered in the study.
Chronic Steroid Use:
The impact of chronic steroid use on anastomotic leak rates was evaluated.
Anemia and Hypoalbuminemia:
The study assessed anemia (hemoglobin levels <10 g/dL) and hypoalbuminemia (serum albumin levels <3 g/dL) as potential risk factors for anastomotic leaks.
Leukocytosis:
Leukocytosis (elevated white blood cell count) was also examined as a risk factor.
Surgical Factors Considered
Surgical Technique:
The study evaluated whether the type of surgical technique (hand-sewn vs. stapled anastomosis) influenced the occurrence of anastomotic leaks.
Location of Anastomosis:
The effect of the location of the anastomosis (e.g., distal vs. proximal) on the risk of leaks was considered.
Duration of Surgery:
The study examined whether longer surgeries (lasting over 4 hours) were associated with a higher incidence of leaks.
Surgeon Experience:
The impact of surgeon experience on leak rates was considered, focusing on procedures performed by residents versus consultants.
DULK Score and Leak Detection The DULK score, a clinical scoring system, was used in the study to predict the likelihood of an anastomotic leak in the early postoperative period. Its role in identifying high-risk patients was an important aspect of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing elective intestinal anastomosis procedures | – | –The SMS Medical College Elective Intestinal Anastomosis Cohort is a prospective cohort study that includes patients undergoing elective intestinal anastomosis procedures at the Department of Surgery, SMS Medical College, Jaipur. This cohort consists of 86 patients who underwent various types of elective bowel reconnection surgeries, including jejuno-jejunal, ileo-ileal, ileo-colic, and colo-colic anastomoses, as well as stoma closures, between [study period]. The cohort includes both male and female patients aged 18 years and older who provided informed consent to participate. The primary aim of this cohort study is to assess the incidence and risk factors of anastomotic leaks (AL)-a serious postoperative complication that can significantly impact patient outcomes. Detailed monitoring of preoperative conditions, surgical factors, and postoperative outcomes, the study aims to identify key risk factors associated with AL, including patient comorbidities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study focused on patients undergoing elective intestinal anastomosis procedures at the Department of Surgery, SMS Medical College in Jaipur. These procedures included jejuno-jejunal, ileo-ileal anastomoses, ileo-colic and colo-colic anastomoses, as well as stoma closure. Prior to the surgeries, written informed consent was obtained from the patients. By specifically examining these elective procedures involving various types of anastomoses and stoma closure, the study aimed to investigate and analyse outcomes related to these surgical interventions within the clinical setting of the SMS Medical College in Jaipur.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ANASTOMOTIC LEAK
Time frame: 12 DAYS
The primary outcome measure is the incidence of anastomotic leaks (AL) in patients who undergo elective intestinal anastomosis at SMS Medical College, Jaipur. AL is defined as the failure of the bowel anastomosis to properly heal, leading to the leakage of intestinal contents into the peritoneal cavity, which may result in peritonitis or sepsis. The incidence is assessed in the postoperative period, primarily within the first 12 days following surgery.
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 13 Dec 2024.
- Individual participant dataSharing planned: No. At this stage, the decision regarding whether to share individual participant data (IPD) with other researchers has not been finalized. We are currently evaluating the ethical, legal, and logistical considerations surrounding data sharing, including patient privacy, consent, and institutional guidelines. The primary goal is to ensure that any data shared respects participant confidentiality and complies with relevant regulations. If the decision is made to share the data, it will be made available through a secure platform, with proper oversight and approval from the relevant ethics committees. Further details will be provided once the final decision is made.
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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.
Dr Prabha OM study chair
HOD DEPT OF GENERAL SURGERY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomosis, Leaking, run by Sawai Mansingh Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Dec 2024. 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 India. 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?
ANASTOMOTIC LEAK (time frame: 12 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 13 Dec 2024.