Postoperative Gastrointestinal Dysfunction (POGD)NCT06263101
Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery
An observational study of Postoperative Gastrointestinal Dysfunction (POGD), run by Chaoyang Hospital of China Medical University at 1 site in China.
Trial summary
Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI) after colorectal surgery, is characterized by symptoms such as nausea, vomiting, abdominal distension, and delayed bowel movements. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Gastrointestinal Dysfunction (POGD)
- What is being tested?
- Biochemical testing of abdominal drainage fluid, Cytological examination of abdominal drainage fluid and Peripheral blood cytology tests
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2024to 12 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-80 with preoperative colorectal cancer diagnosis through colonoscopy biopsy underwent laparoscopic radical resection, excluding prior radiotherapy, chemotherapy, or immunotherapy, and voluntarily participated by signing informed consent.
Who may be able to join
- Preoperative diagnosis of colorectal cancer through colonoscopy biopsy.
- Patients aged 18-80 years.
- Underwent laparoscopic radical resection for colorectal cancer with confirmed postoperative pathology.
- No prior radiotherapy, chemotherapy, or immunotherapy before surgery.
- Voluntary participation in the study and signing of a written informed consent form.
Who cannot join
- Pregnant or lactating women.
- Severe liver dysfunction (Child-Pugh class B or above); severe renal dysfunction (serum creatinine level greater than 177).
- Patients with severe heart failure, chronic obstructive pulmonary disease, and other underlying diseases.
- Patients with pre-existing severe infections (developing sepsis or not improving after antibiotic treatment) before surgery.
- Patients with postoperative fistulas or those requiring a two-stage anastomosis.
- Intraoperative and postoperative intraperitoneal chemotherapy.
Show all 10Show fewer
- Blood disorders (leukemia, lymphoma, aplastic anemia, etc.).
- Patient or family member withdraws midway.
- Those with serious post-operative infections (e.g., incisional, lung, and urinary tract infections)
- Intraoperative conversion to open laparotomy.
Trial locations and contacts
1 site in 1 country.
China1 site
Chaoyang Central Hospital of China Medical University
Chaoyang, Liaoning
About this study
Official title: Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Colorectal Surgery. A Monocentric Prospective Observational Study
Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI) after colorectal surgery, is characterized by symptoms such as nausea, vomiting, abdominal distension, and delayed bowel movements. The incidence of this issue varies among medical institutions, impacting patient nutrition, prolonging hospital stays, and increasing healthcare costs.
The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD. Studies have demonstrated changes in inflammatory cells and factors in the abdominal fluid following abdominal surgery, emphasizing the clinical significance of analyzing drainage fluid to predict postoperative gastrointestinal function.
This study analyzes inflammatory markers in drainage fluid following laparoscopic colorectal cancer surgery. The aim is to enhance the accuracy of predicting gastrointestinal recovery outcomes and contribute to the evolving field of Enhanced Recovery After Surgery (ERAS).
Read the detailed description
Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI), is a common gastrointestinal issue that frequently occurs after colorectal surgery. It is characterized by symptoms such as nausea and vomiting, abdominal distension, and delayed defecation and evacuation. The incidence of POI is not clearly defined due to the varying definitions across healthcare institutions, but it is estimated to be approximately 10-30% and is one of the most common complications after colorectal surgery. The occurrence of POI increases the nutritional risk of patients (e.g., malnutrition, myasthenia gravis, malignant morbidity), prolongs the length of hospital stay, increases hospital costs, and significantly adds to the health economic burden.
In 2018, the American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement considered abandoning the traditional definition of POI and proposed a scoring system based on intake, sensation of nausea, vomiting, physical examination, and duration of symptoms (I-FEED). They also introduced a definition of postoperative gastrointestinal dysfunction (POGD) based on scores classifying postoperative gastrointestinal function as normal (0-2), postoperative gastrointestinal intolerance (POGI) (3-5), and postoperative gastrointestinal dysfunction (POGD) (>6).
The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD.
Levels of inflammatory cells and factors in the peritoneal fluid are changed following abdominal surgery in both rodents and humans. Many previous studies have confirmed that the use of drainage fluids also reduces the incidence of elevated inflammatory markers, such as CRP, in the presence of unrelated inflammatory stimuli, such as concurrent infections and systemic diseases. For instance, in other diseases like meningitis, blood IL-6 is less specific than IL-6 in the drainage fluid. In addition, abdominal drainage fluid is more effective and efficient than routinely collected blood for detecting anastomotic leakage (AL) following colorectal cancer surgery. However, fewer studies have been conducted to predict the recovery of postoperative gastrointestinal function by analyzing drainage fluid. We believe that analyzing postoperative gastrointestinal drainage fluid is of greater clinical importance in predicting postoperative gastrointestinal function.
In our study, we collected abdominal drainage fluid near the anastomosis on the first and third day after laparoscopic colorectal cancer surgery for biochemical and cytological tests. These tests included lactate dehydrogenase (LDH), adenosine deaminase (ADA) and albumin. We also performed conventional cytological tests for neutrophils, lymphocytes, monocytes, etc. In addition, we calculated inflammatory indices such as neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR) and prognostic nutrition index (PNI). We also collected peripheral blood for the same cytological indices and evaluated the outcome of the patients' gastrointestinal function recovery using the I-FEED score. In addition, we analyzed the correlation between the above indices and PODG, and combined the inflammation indices of peritoneal drainage and serum to predict the outcome of gastrointestinal function recovery after laparoscopic colorectal cancer surgery aiming to improve the accuracy and effectiveness of prediction and accelerate patient recovery.
- Being tested
- Biochemical testing of abdominal drainage fluid, Cytological examination of abdominal drainage fluid, Peripheral blood cytology tests
- Keywords
- postoperative ileus, drainage fluid, inflammatory markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical testing of abdominal drainage fluidOther
Drainage fluid was collected from patients on the first and third postoperative days to test the levels of three biochemical tests (albumin, lactate dehydrogenase [LDH], adenosine deaminase [ADA]).
Cytological examination of abdominal drainage fluidOther
Cytological examination of abdominal drainage fluid on the first postoperative day and the third postoperative day, calculation of neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI)
Peripheral blood cytology testsOther
Peripheral blood cytology tests on the first postoperative day and the third postoperative day, calculation of Neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet lymphocyte ratio (PLR), systemic immunoinflammatory index (SII)
| Study group | Role | What they receive |
|---|---|---|
| Biomarker-group | We considered for the study all patients diagnosed with colorectal cancer through preoperative colonoscopy, aged 18-80, underwent laparoscopic radical resection with confirmed pathology, without prior radiotherapy, chemotherapy, or immunotherapy, and voluntarily participated in and signed informed consent for the study, collected indicators of inflammation in the peripheral blood and post-operative drainage fluid of enrolled patients on post-operative days 1 and 3. Receives: Other: Biochemical testing of abdominal drainage fluid; Other: Cytological examination of abdominal drainage fluid; Other: Peripheral blood cytology tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1
Our primary endpoint was to assess the role of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1.
Measured: Postoperative day 1
Secondary outcomes (5)
Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3
Our Secondary endpoint was to assess the role of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3.
Measured: Postoperative day 3
Measurement of drainage fluid albumin, adenosine deaminase (ADA), a d lymphocyte-monocyte ratio (LMR) on postoperative day 1
Our Secondary endpoint was to assess the role of drainage fluid albumin, adenosine deaminase (ADA),and lymphocyte-monocyte ratio (LMR) on postoperative day 1.
Measured: Postoperative day 1
Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR) on postoperative day 3
Our Secondary endpoint was to assess the role of drainage fluid albumin, adenosine deaminase (ADA),and lymphocyte-monocyte ratio (LMR) on postoperative day 3.
Measured: Postoperative day 3
Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 1.
Our Secondary endpoint was to assess the role of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 1.
Measured: Postoperative day 1
Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 3.
Our Secondary endpoint was to assess the role of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 3.
Measured: Postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start21 Feb 2024
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative Gastrointestinal Dysfunction (POGD)Studies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chaoyang Hospital of China Medical University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263101
- Sponsor's protocol ID
- ChaoyangHospital
- Status last verified
- Oct 2024
- First submitted
- 30 Jan 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chapman SJ, Pericleous A, Downey C, Jayne DG. Postoperative ileus following major colorectal surgery. Br J Surg. 2018 Jun;105(7):797-810. doi: 10.1002/bjs.10781. Epub 2018 Feb 22.
PubMed 29469195Scarborough JE, Schumacher J, Kent KC, Heise CP, Greenberg CC. Associations of Specific Postoperative Complications With Outcomes After Elective Colon Resection: A Procedure-Targeted Approach Toward Surgical Quality Improvement. JAMA Surg. 2017 Feb 15;152(2):e164681. doi: 10.1001/jamasurg.2016.4681. Epub 2017 Feb 15.
PubMed 27926773Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009 Jul-Aug;15(6):485-94. doi: 10.18553/jmcp.2009.15.6.485.
PubMed 19610681Hedrick TL, McEvoy MD, Mythen MMG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Gastrointestinal Dysfunction Within an Enhanced Recovery Pathway for Elective Colorectal Surgery. Anesth Analg. 2018 Jun;126(6):1896-1907. doi: 10.1213/ANE.0000000000002742.
PubMed 29293183Wehner S, Behrendt FF, Lyutenski BN, Lysson M, Bauer AJ, Hirner A, Kalff JC. Inhibition of macrophage function prevents intestinal inflammation and postoperative ileus in rodents. Gut. 2007 Feb;56(2):176-85. doi: 10.1136/gut.2005.089615. Epub 2006 Jun 29.
PubMed 16809419Bauer AJ. Mentation on the immunological modulation of gastrointestinal motility. Neurogastroenterol Motil. 2008 May;20 Suppl 1:81-90. doi: 10.1111/j.1365-2982.2008.01105.x.
PubMed 18402645
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Colorectal Surgery. A Monocentric Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06263101
- Acronym / sponsor ID
- ChaoyangHospital
- Keywords
- postoperative ileus, drainage fluid, inflammatory markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Chaoyang Hospital of China Medical UniversityOther government
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 16 Feb 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.
Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI) after colorectal surgery, is characterized by symptoms such as nausea, vomiting, abdominal distension, and delayed bowel movements. The incidence of this issue varies among medical institutions, impacting patient nutrition, prolonging hospital stays, and increasing healthcare costs.
The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD. Studies have demonstrated changes in inflammatory cells and factors in the abdominal fluid following abdominal surgery, emphasizing the clinical significance of analyzing drainage fluid to predict postoperative gastrointestinal function.
This study analyzes inflammatory markers in drainage fluid following laparoscopic colorectal cancer surgery. The aim is to enhance the accuracy of predicting gastrointestinal recovery outcomes and contribute to the evolving field of Enhanced Recovery After Surgery (ERAS).
Detailed description
Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI), is a common gastrointestinal issue that frequently occurs after colorectal surgery. It is characterized by symptoms such as nausea and vomiting, abdominal distension, and delayed defecation and evacuation. The incidence of POI is not clearly defined due to the varying definitions across healthcare institutions, but it is estimated to be approximately 10-30% and is one of the most common complications after colorectal surgery. The occurrence of POI increases the nutritional risk of patients (e.g., malnutrition, myasthenia gravis, malignant morbidity), prolongs the length of hospital stay, increases hospital costs, and significantly adds to the health economic burden.
In 2018, the American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement considered abandoning the traditional definition of POI and proposed a scoring system based on intake, sensation of nausea, vomiting, physical examination, and duration of symptoms (I-FEED). They also introduced a definition of postoperative gastrointestinal dysfunction (POGD) based on scores classifying postoperative gastrointestinal function as normal (0-2), postoperative gastrointestinal intolerance (POGI) (3-5), and postoperative gastrointestinal dysfunction (POGD) (>6).
The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD.
Levels of inflammatory cells and factors in the peritoneal fluid are changed following abdominal surgery in both rodents and humans. Many previous studies have confirmed that the use of drainage fluids also reduces the incidence of elevated inflammatory markers, such as CRP, in the presence of unrelated inflammatory stimuli, such as concurrent infections and systemic diseases. For instance, in other diseases like meningitis, blood IL-6 is less specific than IL-6 in the drainage fluid. In addition, abdominal drainage fluid is more effective and efficient than routinely collected blood for detecting anastomotic leakage (AL) following colorectal cancer surgery. However, fewer studies have been conducted to predict the recovery of postoperative gastrointestinal function by analyzing drainage fluid. We believe that analyzing postoperative gastrointestinal drainage fluid is of greater clinical importance in predicting postoperative gastrointestinal function.
In our study, we collected abdominal drainage fluid near the anastomosis on the first and third day after laparoscopic colorectal cancer surgery for biochemical and cytological tests. These tests included lactate dehydrogenase (LDH), adenosine deaminase (ADA) and albumin. We also performed conventional cytological tests for neutrophils, lymphocytes, monocytes, etc. In addition, we calculated inflammatory indices such as neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR) and prognostic nutrition index (PNI). We also collected peripheral blood for the same cytological indices and evaluated the outcome of the patients' gastrointestinal function recovery using the I-FEED score. In addition, we analyzed the correlation between the above indices and PODG, and combined the inflammation indices of peritoneal drainage and serum to predict the outcome of gastrointestinal function recovery after laparoscopic colorectal cancer surgery aiming to improve the accuracy and effectiveness of prediction and accelerate patient recovery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker-group | – | Other: Biochemical testing of abdominal drainage fluid, Other: Cytological examination of abdominal drainage fluid, Other: Peripheral blood cytology testsWe considered for the study all patients diagnosed with colorectal cancer through preoperative colonoscopy, aged 18-80, underwent laparoscopic radical resection with confirmed pathology, without prior radiotherapy, chemotherapy, or immunotherapy, and voluntarily participated in and signed informed consent for the study, collected indicators of inflammation in the peripheral blood and post-operative drainage fluid of enrolled patients on post-operative days 1 and 3. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-80 with preoperative colorectal cancer diagnosis through colonoscopy biopsy underwent laparoscopic radical resection, excluding prior radiotherapy, chemotherapy, or immunotherapy, and voluntarily participated by signing informed consent.
Key inclusion criteria (5 listed)
- Preoperative diagnosis of colorectal cancer through colonoscopy biopsy.
- Patients aged 18-80 years.
- Underwent laparoscopic radical resection for colorectal cancer with confirmed postoperative pathology.
- No prior radiotherapy, chemotherapy, or immunotherapy before surgery.
- Voluntary participation in the study and signing of a written informed consent form.
Key exclusion criteria (10 listed)
- Pregnant or lactating women.
- Severe liver dysfunction (Child-Pugh class B or above); severe renal dysfunction (serum creatinine level greater than 177).
- Patients with severe heart failure, chronic obstructive pulmonary disease, and other underlying diseases.
- Patients with pre-existing severe infections (developing sepsis or not improving after antibiotic treatment) before surgery.
- Patients with postoperative fistulas or those requiring a two-stage anastomosis.
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 |
|---|---|---|
| Biochemical testing of abdominal drainage fluidDrainage fluid was collected from patients on the first and third postoperative days to test the levels of three biochemical tests (albumin, lactate dehydrogenase [LDH], adenosine deaminase [ADA]). | Other | Biomarker-group |
| Cytological examination of abdominal drainage fluidCytological examination of abdominal drainage fluid on the first postoperative day and the third postoperative day, calculation of neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) | Other | Biomarker-group |
| Peripheral blood cytology testsPeripheral blood cytology tests on the first postoperative day and the third postoperative day, calculation of Neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet lymphocyte ratio (PLR), systemic immunoinflammatory index (SII) | Other | Biomarker-group |
Primary outcome
Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1
Time frame: Postoperative day 1
Our primary endpoint was to assess the role of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1.
5 secondary outcomes
Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3
Time frame: Postoperative day 3
Measurement of drainage fluid albumin, adenosine deaminase (ADA), a d lymphocyte-monocyte ratio (LMR) on postoperative day 1
Time frame: Postoperative day 1
Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR) on postoperative day 3
Time frame: Postoperative day 3
Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 1.
Time frame: Postoperative day 1
Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 3.
Time frame: Postoperative day 3
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 27 Dec 2024.
- Background: PubMed 29469195Chapman SJ, Pericleous A, Downey C, Jayne DG. Postoperative ileus following major colorectal surgery. Br J Surg. 2018 Jun;105(7):797-810. doi: 10.1002/bjs.10781. Epub 2018 Feb 22.
- Background: PubMed 27926773Scarborough JE, Schumacher J, Kent KC, Heise CP, Greenberg CC. Associations of Specific Postoperative Complications With Outcomes After Elective Colon Resection: A Procedure-Targeted Approach Toward Surgical Quality Improvement. JAMA Surg. 2017 Feb 15;152(2):e164681. doi: 10.1001/jamasurg.2016.4681. Epub 2017 Feb 15.
- Background: PubMed 19610681Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009 Jul-Aug;15(6):485-94. doi: 10.18553/jmcp.2009.15.6.485.
- Background: PubMed 29293183Hedrick TL, McEvoy MD, Mythen MMG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Gastrointestinal Dysfunction Within an Enhanced Recovery Pathway for Elective Colorectal Surgery. Anesth Analg. 2018 Jun;126(6):1896-1907. doi: 10.1213/ANE.0000000000002742.
- Background: PubMed 16809419Wehner S, Behrendt FF, Lyutenski BN, Lysson M, Bauer AJ, Hirner A, Kalff JC. Inhibition of macrophage function prevents intestinal inflammation and postoperative ileus in rodents. Gut. 2007 Feb;56(2):176-85. doi: 10.1136/gut.2005.089615. Epub 2006 Jun 29.
- Background: PubMed 18402645Bauer AJ. Mentation on the immunological modulation of gastrointestinal motility. Neurogastroenterol Motil. 2008 May;20 Suppl 1:81-90. doi: 10.1111/j.1365-2982.2008.01105.x.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Gastrointestinal Dysfunction (POGD), run by Chaoyang Hospital of China Medical University at 1 site in China.
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 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: finished, as of the sponsor's last update on 27 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 China. 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?
Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1 (time frame: Postoperative day 1). 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 NCT06263101, which also lists 6 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 27 Dec 2024.