Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Digestive System Diseases

Ulcer

Thrombosis

Crohn Disease

Colitis

Colitis, Ulcerative

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Diverticulum

Diverticular Diseases

Gastrointestinal Diseases

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Embolism

Embolism and Thrombosis

Vascular Diseases

Pathological Conditions, Anatomical

Coagulants

All Drugs and Chemicals

Anticoagulants

Fibrin fragment D

Fibrin Fibrinogen Degradation Products

Antifibrinolytic Agents

Hemostatics

Subjects who meet the inclusion criteria that will have colorectal surgery at UTMB

D-dimer blood test- The D-dimer assay detects the presence of fibrin degradation products, which can indicate the breakdown of a fibrin clot Lower Limb Venous Duplex- Using an ultrasound to visually look for a clot

D-dimer and lower limb venous duplex

Uma Phatak, MD

The purpose of this study is to evaluate the use of a D-dimer based protocol to screen for thrombotic events in colorectal surgical patients. This study is unique because of the multistage screening process for DVT's using a standardized D-dimer testing methodology and ultrasound that will take place throughout the preoperative, perioperative, and postoperative processes. The data collected from this screening study will help establish the baseline DVT rates in UTMB's colorectal surgical patients before and after surgery. Additionally, the data from this study can help determine if a D-dimer blood test has predictive value in UTMB's colorectal surgical patient population. This study may also provide preliminary evidence for further research regarding the adjustment of D-dimer cutoff values. Specifically for patient subsets such as surgical colorectal patients with a moderate pretest probability and clinical conditions associated with low test specificity

This will be a quantitative prospective cohort study conducted at the University of Texas Medical Branch (UTMB) Galveston and League City campuses. Candidates include subjects who will have elective colorectal surgery at UTMB. This study looks to enroll 100 subjects who meet inclusion criteria. The subjects will undergo screening for DVT using a lower limb bilateral venous duplex and a plasma D-dimer assay no longer than 10 days before their operation. This data will be used to observe the point prevalence of DVT's in preoperative colorectal subjects prior to having colorectal surgery. On the day of surgery, the subject will have a D-dimer test. After the operation, for next 2 days the subjects will have a daily D-dimer test and a lower limb bilateral venous duplex on the second day only. This data will determine the incidence of DVT's that were detected by lower limb bilateral venous duplex on inpatient stay day 2 and possibly indicated by an upward trending D-dimer value during the first 2 days of the inpatient stay. Approximately 2 weeks after surgery, at the postoperative clinic appointment, the subject will have a D-dimer assay and a lower limb bilateral venous duplex. This information will be used to determine the number of DVT events in postoperative colorectal hospitalized subjects that were on the D-dimer monitoring protocol. The D-dimer assay detects the presence of fibrin degradation products, which may indicate a fibrin blood clot in the body.6 A maximum of 5 milliliters of blood will be collected for each D-dimer test. If a DVT is detected by the gold standard method which is a bilateral lower limb duplex during any point of study, the subject will be treated as per standard of care at UTMB by the colorectal surgical team

The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients

The data will be used to discover the prevalence of DVT prior to surgery and to establish DVT baseline rates at UTMB.

Subjects will have a venous duplex on day two after surgery to look for a DVT

The data will be used to determine the number of DVT's that were discovered in the subject population and to establish baseline rates of DVT after surgery and hospital discharge

This data will be used to compare the D-dimer values in subjects that had DVT prior to surgery to those who developed a postoperative DVT while inpatient or at the postoperative clinic appointment

These results will be used as preliminary evidence for future research to determine if revised D-dimer cut off values can be diagnostic in conditions known to have low test specificity

The University of Texas Medical Branch, Galveston

Study Population and Enrollment. To ensure survey feasibility and acceptability for our target population we will purposively recruit older African American patients at each of the three participating sites. Using conservative estimates of clinical volume as well as US county level census data we estimate enrolling 3 elderly (\>65 years of age) African American participants per site per week with a target enrollment of 12 patients per site.

To gain a broad understanding of barriers to surgical access and care in the Deep South, each study site will conduct key informant interviews. Participants will be recruited from five socioecological levels: patient, caregivers/provider, organizational, community, and policy-levels. At each site, two key informant interviews will be performed at each socioecological level (2 patients, 2 caregivers, 2 providers, 2 organizational leaders, 2 community leaders, and 2 policy leaders = 12 per site). We will purposively sample 100% of the participants at the patient and caregiver level (n=12) to be African American and \>65 years old.

Enrollment Process. Eligibility criteria for this phase of study enrollment will be broadened to include all English-speaking patients \>18 years of age undergoing or having recently undergone (\<7 days) an ACS-NSQIP defined surgical procedure. At each site, eligible participants will be approached by a trained research associate pre-operatively in clinic (for elective cases) or post-operatively in the hospital (for emergency cases \<7 days). Because each enrollment site has a unique schedule, site representatives will coordinate the most efficient weekly schedule.

We expect to reach our target enrollment (100 participants total, 33 at each site) in 1 year based on conservative estimates of clinical case volume. We expect to enroll at least 20% elderly participants (\>65 years of age) and between 30-50% African American participants based on county level (Greenville - Butler County, Demopolis - Marengo County, Alexander City - Tallapoosa County) census data.

This study will not involve an intervention of any sort. Participants will either take a survey or undergo an interview, and those taking the survey will have clinical data captured.

no intervention

Daniel I Chu, MD

Rationale: Older African Americans undergoing surgery are a vulnerable and growing population at high risk for poor surgical outcomes and disparities. Few programs have focused on this population due to a fragmented understanding of the needs of this population.

Objectives: While socioecological determinants of health (SEDOH) such as health literacy and socioeconomic status are known drivers of surgical disparities, an estimated 36-47% of surgical disparities remains unexplained. This gap results from limitations of current clinical datasets in capturing SEDOHs. This pilot study aims to fill this gap by (i) collecting granular SEDOH data, (ii) identifying barriers to surgical care for older African Americans, and (iii) establishing a multi-institutional clinical database through a socioecological context. These findings will help understand how SEDOHs drive surgical disparities and inform development of interventions to eliminate them in elderly African Americans.

Design and Methods: Guided by the socioecological model of health, the investigators will use mixed-methods to achieve the objectives. First, the investigators will assess the acceptability and feasibility of a 58-item SEDOH survey based on the NIH PhenX toolkit. After distributing this survey to 36 elderly (≥65 years) African American patients undergoing surgery at 3 rural, UAB-affiliated hospitals (Alex-City, Greenville, Demopolis) the investigators will conduct detailed theory guided assessments of acceptability and feasibility (SA1). Second, the investigators will conduct key informant interviews of individuals from all 5 socioecological levels at each rural hospital (n=10) to identify additional barriers and facilitators to surgical care. The investigators will purposively sample 100% of participants at the patient and caregiver level (n=12) to be elderly African Americans (SA2). Finally, the investigators will link measured SEDOH data with standardized clinical data at each hospital to establish a novel database (SA3). These findings will establish a process to measure SEDOHs across the Deep South and set the foundation for a unique database to study surgical disparities.

Significance: Development of effective multilevel interventions to eliminate surgical disparities in older African Americans is dependent on a clearer understanding of the contextual drivers of these disparities. This pilot study will accelerate understanding of these mechanism(s) through SEDOHs. It will establish a process to measure SEDOHs, identify additional barriers to surgical care not captured by NIH instruments, and build the database to study these relationships. Such findings will have the potential to impact vulnerable surgical populations in the Deep South and support the Deep South RCMAR mission to promote health and optimize health outcomes for older and rural African Americans.

The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health

Primary data acquired through the quantitative surveys and other demographics will be collected and managed using REDCap (Research Electronic Data Capture). As the host/coordinating center, UAB REDCap servers are secured through a virtualized environment behind an enterprise grade Palo Alto firewall. Only IRB-approved research team members will have access to the REDCap system through a secure and unique login. UAB REDCap is in compliance with NIST 800-53/800-171 (HIPAA) and FDA CFR21 part 11 guidelines, approved by all authorizing parties at UAB and authorized to operate (ATO) from NIH/NHLBI.

Using a theory guided framework and previously published measures of acceptability and feasibility, a post survey will be administered to all participants in specific aim 1. Feasibility and acceptability scores will be calculated, with positive acceptability and feasibility being indicated by scores of 4 or greater on a likert scale. The investigators will ensure that the survey is found to be acceptable and feasible to \>70% of the target population, and will have areas for qualitative feedback and comments to adapt the survey as needed.

To identify barriers to surgical care for older African American patients in the Deep South the investigators will conduct qualitative interviews of participants at all socioecological levels at each site. These interviews will be transcribed and coded using NVivo software, and themes from this analysis will be compared with the domains assessed in the survey used in specific aim 1 in order to ensure that all relevant domains are captured and assessed.

To establish a database linking socioecological determinants of health with nationally validated surgical outcomes the investigators will pair data obtained from the previously developed survey with chart abstracted clinical outcomes data. All data will be stored in a secure RedCap database, and entered only by trained abstractors.

University of Alabama at Birmingham

Associate Professor

Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Rectal Diseases

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

Participants after Hartmann procedure, who were qualified and underwent Endoscopic Ultrasound- Guided Hartmann Reversal Procedure.

EndoHARP is a new technique proposed to restore gastrointestinal continuity after the Hartmann's procedure. For EndoHARP, a fixed loop of the large intestine will be identified on endosonography after an echoendoscope is inserted into the rectal stump under endoscopic guidance. Then, using the set for inserting self-expandable metal transmural endoprosthesis (20 mm in diameter and 10 mm in length) with electrocautery (as in endoscopic gastroenterostomy), EUS-guided anastomosis of the rectal stump to the large intestine loop will be performed, allowing the natural passage of intestinal contents through the endoscopic anastomosis, restoring gastrointestinal continuity. The aim of leaving the self-expandable transmural endoprosthesis in the anastomosis is not only to maintain the patency of the intestinal anastomosis of at least 20 mm in diameter, but also to diminish the risk of endoscopic intestinal anastomotic leak by completely covering the prosthesis with a polymer layer.

Endoscopic restoration of gastrointestinal continuity after Hartmann procedure

Mateusz Jagielski, Prof.

Michał Spychalski, Ass. Prof.

The goal of this clinical trial is to learn about clinical usefulness endoscopic gastrointestinal anastomoses to restore the gastrointestinal continuity in patients with permanent colostomy after Hartmann procedure.

The main questions it aims to answer are:

* is the endoscopic restore the gastrointestinal continuity procedure effective?
* is this endoscopic procedure safe?

Large intestinal resection is performed for both elective and acute reasons. The choice of surgical technique is determined not only by the oncological treatment outcome, but also by the patient's quality of life after surgery. Intestinal anastomosis is associated with the risk of leakage, which is one of the most serious complications of colorectal surgery. In the event of this complication, the most common treatments are relaparotomy/relaparoscopy and disconnection of the anastomosis with stoma formation. The patient's condition is most often critical, and the mortality associated with this complication ranges from 1.3 to 27% depending on the patient's age. In addition, dehiscence of the intestinal anastomosis during oncological surgery is an independent factor that increases the risk of local recurrence and shortens disease-related survival. In contrast, avoiding primary anastomosis and performing Hartmann's surgery (resection with the formation of an end colostomy) is safer for the patient as there is no risk of anastomotic leak. However, this procedure is not ideal. The patient undergoes an end colostomy, which is often difficult for the patient to accept, especially during the initial period. Restoration of gastrointestinal continuity is possible a few months after primary surgery. In colorectal cancer, it can be treated only after the completion of adjuvant chemotherapy, which significantly prolongs this process. Stoma closure has never been attempted in many patients because of the risks associated with another major surgery. Therefore, it is not surprising that there is a trend towards performing primary anastomosis. In experienced centers, the risk of anastomotic dehiscence is at an acceptable level of less than 5% for elective surgeries. In contrast, the percentage is higher for acute surgeries, accounting for up to 20% of emergency indications, especially in centers inexperienced in colorectal surgery. Gastrointestinal obstruction, which is most often associated with colorectal tumors, leads to dilatation of the proximal segment of the large intestine (above the tumor) with wall thickening. Disproportion in diameter, edema, thickening of the intestinal wall, and serious conditions with accompanying malnutrition significantly increased the risk of anastomotic leak in this group of patients. Currently, due to advances in pharmacological treatment and interventional radiology (percutaneous abscess drainage), surgical treatment involving segmental intestinal resection is reserved for patients with diffuse peritonitis. In this group of patients, resection with a primary anastomosis is associated with a very high risk of anastomotic failure, and Hartmann's resection remains the safest option.

Previous methods for restoring gastrointestinal continuity after Hartmann's procedure required extensive surgery. The first stage of surgery involves the dissection of adhesions after the previous resection. It is usually the most technically difficult stage of the procedure because of the emergency nature of the primary surgery (obstruction/peritonitis). Once the intestinal adhesions are removed, the colostomy is dissected from the wall, and the descending and sigmoid colons are mobilized. This is most often associated with the need to release splenic flexure. The next step is to identify and mobilize the rectal stump. This is necessary for a safe intestinal anastomosis, which is most often performed using a circular stapler. If a long rectal stump remains after the primary surgery, insertion of the stapler into its terminal segment is sometimes difficult and involves dissection and cutting of the pelvic peritoneum. Restoring gastrointestinal continuity after Hartmann's surgery is technically difficult and carries a high risk of intra- and perioperative complications, with the most common being small/large intestinal injury during adhesion dissection, intraoperative bleeding, ureteral/bladder injury, and splenic injury (most often, the splenic flexure needs to be released). No technical possibility of reconstruction is common (displacement of the rectal stump deep inside the pelvis and shortening of the mesentery of the left half of the colon). The risk of complications related to the restoration of gastrointestinal continuity after Hartmann's surgery is 30-60%; thus, a significant number of patients do not consent to this procedure.

The endoHARP procedure proposed in this article allows easier restoration of gastrointestinal continuity owing to the combination of classic colorectal surgical techniques with endosonography techniques. The technical details of the procedure are described later in this article. To ensure the feasibility of the endoHARP procedure, it is necessary to slightly modify the primary resection procedure using Hartmann's method. After the resection stage, which does not differ from the original surgery, the remaining parts of the sigmoid and descending colon should be mobilized at the promontorium level. This allows fixation of the closed rectal stump. Side-to-end anastomosis of the intestine to the rectal stump was performed using four 3-0 absorbable sutures. The end of the sigmoid colon is typically brought out into the left middle abdomen. However, this procedure may not be feasible for all patients. It is not possible to use this modification in most cases involving a short segment of the remaining left half of the colon, those with inflammatory infiltration within the mesentery, or those requiring anterior rectal resection (low-sigmoid tumors). However, this modification is technically feasible in a considerable number of patients undergoing Hartmann's procedure.

The steps of the modified Hartmann's sigmoid resection procedure are summarized below.

1. Resection of the sigmoid colon performed as in the original method
2. Mobilization of the remaining part of the sigmoid and descending colon
3. Possible mobilization of the splenic flexure
4. Fixation of the descending and sigmoid colon to the rectal stump with four 3-0 serous sutures

Endoscopic ultrasound (EUS)-guided restoration of gastrointestinal continuity At least 12 weeks (ranging from 3 to 6 months) should elapse between the formation of the colostomy and its closure (i.e., restoration of gastrointestinal continuity). The classic method for the restoration of gastrointestinal continuity involves opening the abdominal cavity, dissection of the intestinal stump and stoma and its closure, enteroenteric anastomosis with manual or mechanical sutures, and closure of the abdominal cavity. However, during the restoration of gastrointestinal continuity after opening the abdominal cavity, the surgeon usually finds numerous adhesions from the previous surgery, which technically impedes the procedure and requires careful dissection to avoid iatrogenic intestinal perforation. In some cases, anatomical conditions encountered after opening the abdominal cavity prevent surgery. The patient is then destined to have a permanent stoma because the restoration of gastrointestinal continuity is technically impossible. In addition, surgical procedures to restore gastrointestinal continuity are associated with the risk of enteroenteric anastomotic leakage.

Recent developments in interventional endoscopy of the gastrointestinal tract and the therapeutic use of EUS have enabled endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore gastrointestinal continuity in patients with high gastrointestinal obstruction. During EUS-guided gastroenterostomy, the gastric lumen is anastomosed to the small intestinal lumen (gastrointestinal anastomosis). Endoscopic anastomosis of the stomach to the small intestine in patients with high gastrointestinal obstruction is performed by inserting a self-expandable metal transmural endoprosthesis (20 mm in diameter and 10 mm in length) using electrocautery under endoscopic, fluoroscopic, and endosonography guidance. A similar approach will be used in our EndoHARP technique to restore gastrointestinal continuity after the Hartmann's procedure. For EndoHARP, a fixed loop of the large intestine will be identified on endosonography after an echoendoscope is inserted into the rectal stump under endoscopic guidance. In addition, a contrast agent administered through colostomy will fill the intestinal loop which will be visible on both EUS and fluoroscopy, improving visibility during endoscopic surgery. Then, using the set for inserting self-expandable metal transmural endoprosthesis (20 mm in diameter and 10 mm in length) with electrocautery (as in endoscopic gastroenterostomy), EUS-guided anastomosis of the rectal stump to the large intestine loop will be performed, allowing the natural passage of intestinal contents through the endoscopic anastomosis, restoring gastrointestinal continuity. The aim of leaving the self-expandable transmural endoprosthesis in the anastomosis is not only to maintain the patency of the intestinal anastomosis of at least 20 mm in diameter, but also to diminish the risk of endoscopic intestinal anastomotic leak by completely covering the prosthesis with a polymer layer.

After endoscopic surgery, the patients will undergo a gastrointestinal passage examination with a contrast agent for four weeks. If the patency of the endoscopic enterorectal anastomosis is confirmed radiologically, the patient will be eligible for colostomy closure in a traditional surgical procedure (i.e., cutting and closing the colostomy with a linear stapler, returning it to the abdominal cavity without the need for intestinal dissection, removal of peritoneal adhesions, and most importantly, for intestinal anastomosis). Thus, the risks of intestinal anastomotic leakage and iatrogenic intestinal perforation during dissection are avoided, thereby increasing the safety of the procedure. Then, the skin area after colostomy will be closed in layers. The metal endoprosthesis will be simultaneously removed from the enterorectal anastomosis during the surgical closure of the colostomy. At this point, the interventional treatment is completed, and gastrointestinal continuity is permanently restored.

The patient will be followed up periodically in the Surgical Clinic every 3 months for the first 12 months after surgery and every 6 months for the next 4 years. Follow-up endoscopic examinations of the lower gastrointestinal tract with evaluation of enterorectal anastomosis will be scheduled every 3-6-12 months, and then every 3 years for the next 9 years.

Number of participants necessary to demonstrate an effect is 100.

The stages of EUS-guided restoration of gastrointestinal continuity are summarized below.

THE FIRST STAGE of endoscopic restoration of gastrointestinal continuity

1. Administration of a contrast agent through the stoma to the intestinal loop
2. Insertion of the echoendoscope into the rectal/colon stump and identification of fixed and contrast-filled large/small intestinal loops on EUS
3. Performance of EUS-guided enterorectal/enteroenteric anastomosis using a set for inserting a self-expandable metal transmural endoprosthesis with electrocautery

   1. performance of a transmural/transrectal puncture using electrocautery
   2. expansion of the transmural endoprosthesis through the puncture site
   3. contrast administration through anastomosis to confirm the tightness of enterorectal/enteroenteric anastomosis
   4. Extend the transmural endoprosthesis lumen with a high-pressure balloon up to 20 mm in diameter.

THE SECOND STAGE (after four weeks) of endoscopic restoration of gastrointestinal continuity

One surgical team

1. Circular incision around the stoma
2. Closure of colostomy with a linear stapler
3. Return of the closed intestinal loop into the abdominal cavity
4. Skin closure

Simultaneously - second surgical team (endoscopic)

1. Insertion of the endoscope into the rectum
2. Seizure of the transmural endoprosthesis with endoscopic forceps
3. Removal of the endoprosthesis
4. Endoscopic and fluoroscopic follow-up of endoscopic intestinal anastomosis

Endoscopic Ultrasound- Guided Hartmann Reversal Procedure

Endoscopic Reconstruction of the Gastrointestinal Tract After Surgical Resection Procedures Within the Large Intestine (Hartmann's Procedure- Modification of the Method Facilitating the Restoration of Gastrointestinal Continuity)

Evaluation of efficacy based on patency of endoscopic entero-rectal anastomosis confirmed radiologically and endoscopically.

Unit of Measure: the number of participants with patency of endoscopic entero-rectal anastomosis compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)

Evaluation of all complications in patients with endoscopic gastrointestinal anastomoses (Endo-HARP).

Unit of Measure: the number of participants with complications compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).

Evaluation of early complications within thirty days from onset of endoscopic gastrointestinal anastomoses (Endo-HARP) procedure.

Unit of Measure: the number of participants with early complications compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).

Evaluation of late complications after thirty days from onset of endoscopic gastrointestinal anastomoses (Endo-HARP) procedure.

Unit of Measure: the number of participants with late complications compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).

Assessment of correct conduct of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP) according to study protocol.

Unit of Measure: the number of participants with technical success to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).

Assessment of clinical results of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).

Unit of Measure: the number of participants with clinical success to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients	NCT05246943	Venous Thrombos... Colorectal Canc... Diverticular Di... Crohn Disease Ulcerative Coli... Deep Vein Throm...	D-dimer and low...	18 Years -	The University of Texas Medical Branch, Galveston
The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health	NCT05345054	Colorectal Canc... Inflammatory Bo... Diverticular Di... Social Behavior	no intervention	18 Years -	University of Alabama at Birmingham
Endoscopic Ultrasound- Guided Hartmann Reversal Procedure	NCT06061432	Colorectal Neop... Diverticular Di... Inflammatory Bo...	Endoscopic rest...	18 Years -	Nicolaus Copernicus University
The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients	NCT05246943	Venous Thrombos... Colorectal Canc... Diverticular Di... Crohn Disease Ulcerative Coli... Deep Vein Throm...	D-dimer and low...	18 Years -	The University of Texas Medical Branch, Galveston
The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health	NCT05345054	Colorectal Canc... Inflammatory Bo... Diverticular Di... Social Behavior	no intervention	18 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for diverticular diseases