Anastomotic Leak

12

Review clinical trials related to Anastomotic Leak. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections

The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.

Participants needed: 137
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Medtronic - MITGUpdated: Jun 12, 2026Locations: 9
Eligibility criteria

Subject is competent and willing to provide documented informed consent to parti... [+2]

Subject is unable or unwilling to comply with the study requirements or follow-u... [+14]

Status: Recruiting

Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy

The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to the anastomosis leakage rate published in the literature for totally handsewn or stapled-handsewn ileo-colic anastomosis.

Participants needed: 249
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Aesculap AGUpdated: Jun 9, 2026Locations: 4
Eligibility criteria

Patients undergoing a primary, elective either open or laparoscopic right hemico... [+6]

Left hemicolectomy or left extended hemicolectomy or sigma resection [+7]

Status: Recruiting

Anastomotic Leakage After Colorectal Surgery.

Anastomotic leakage (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center observational cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model. Approximately 430 patients undergoing colorectal resection with anastomosis will be enrolled from August 2025 to August 2026. Risk factors will be assessed preoperatively, intraoperatively, and postoperatively. AL will be defined and graded per the International Study Group of Rectal Cancer (ISGRC) criteria.

Participants needed: 430
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Minia UniversityUpdated: May 19, 2026Locations: 1Duration: 1 Year
Eligibility criteria

Aged ≥18 years [+2]

Colorectal resection without anastomosis (e.g., end stoma) [+4]

Status: Recruiting

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery

In colorectal surgery, one of the most feared complications is anastomotic leak (AL). To limit the consequences of AL, it must be diagnosed as early as possible, before it becomes symptomatic. Digestive surgeons use a variety of pre-, per- and post-operative techniques to reduce the rate of anastomotic fistula, but the risk persists, with a rate of 7% reported in the literature. It has been shown that the value of CRP between D1 and D5 correlates with the risk of AL, and that the trajectory between two consecutive days (D1 to D5 post-op) is the most discriminating element in predicting the risk of AF. This assay requires repeated intravenous sampling, which is the opposite of simplifying care. CRP point-of-care testing (POCT) is used in clinical practice, notably in pediatrics and outpatient medicine (in children and adults) to help prescribe probabilistic antibiotic therapy, as the instantaneousness of the result has an impact on patient management. For the diagnosis of AL, CRP POCT assessment could reduce the number of blood samples taken, shorten the time between sampling and medical management in cases of suspected AL, and thus improve the patient's post-operative experience.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: Mar 11, 2026Locations: 1
Eligibility criteria

Patients undergoing elective (non-emergency) colorectal surgery, regardless of t...

No anastomosis [+4]

Status: Recruiting

Registry Study of People Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak

The main purpose of this study is to look at how often anastomotic leaks happen in participants who are at high risk of these leaks and are eligible to receive gastric preconditioning by percutaneous angioembolization before an esophagectomy.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Memorial Sloan Kettering Cancer CenterUpdated: Mar 4, 2026Locations: 7Duration: 1 Year
Eligibility criteria

Documentation of Disease [+11]

Status: Recruiting

Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer

The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life. The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.

Participants needed: 256
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Sixth Affiliated Hospital, Sun Yat-sen UniversityUpdated: Dec 18, 2025Locations: 1
Eligibility criteria

Men or women, aged between 18 and 75 years; [+6]

Previous history of malignant colorectal tumors; [+11]

Status: Recruiting

PARLAR-02 Trial:Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage

Surgical resection remains the primary treatment for rectal cancer, but the postoperative incidence of anastomotic leakage (AL) is relatively high. AL not only increases the medical burden on patients, prolongs hospital stays, raises the need for secondary surgery, and elevates perioperative mortality, but also increases the long-term risk of local recurrence and reduces survival rates. There is an urgent need for a simple, effective treatment method that minimizes the burden on patients to prevent anastomotic leakage. The preoperative placement of a transanal drainage tube (TDT) is believed to effectively drain gas and feces from the intestinal lumen, thereby reducing intestinal pressure and alleviating tension at the anastomotic site, thus preventing AL. Previous studies have shown that traditional drainage tubes cannot effectively prevent leakage. Given the limitations of existing research on traditional TDTs, we plan to use a modified TDT (which allows postoperative irrigation and utilizes a balloon to block feces from adversely affecting the anastomosis) to conduct a randomized, parallel-controlled trial. This study aims to further investigate the role of the modified TDT in preventing and treating anastomotic leakage following rectal surgery

Participants needed: 968
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Third Military Medical UniversityUpdated: Jun 25, 2025Locations: 1
Eligibility criteria

Rectal adenocarcinoma (confirmed by pathology); [+7]

Emergency surgery; [+5]

Status: Recruiting

Resumption of Enteral Feeding After Bowel Anastomosis

Resumption of oral feeding after small intestine surgery is a matter of controversy .Some surgeons advocate early resumption while others don't.early feeding is initiated as soon as the patient recovers from effects of anaesthesia, while late resumption is started after 24-48 hours after surgery.Recent studies and guidelines suggest early feeding. The aim of this study is to compare the early and late resumption of oral feeding.

Participants needed: 204
Trial details
Age: 15-65Biological sex: AllType: InterventionalSponsor: Khyber Teaching HospitalUpdated: Apr 2, 2025Locations: 1
Eligibility criteria

All patients undergoing small bowel anastomosis for any indication in elective s... [+2]

Patient using glucocorticoids or other immunosuppressive drugs [+2]

Status: Not yet recruiting

Evaluating the Effective and Safe Use of Stream™ Platform

The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform. Safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use. Additionally, clinical testing will be conducted to identify correlations between measurements from Stream™ Platform and standard laboratory, radiological, and clinical assessments used for leak detection as part of the current standard of care (SOC) that may be skipped if the subject is discharged early.

Participants needed: 25
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: FluidAI MedicalUpdated: Feb 28, 2025Locations: 1
Eligibility criteria

Age ≥ 18 years - male or female. [+4]

Subjects/caregiver is unwilling or unable to comply with the requirements of the... [+11]

Status: Recruiting

Anastomotic Leakage in Right Colectomy

Data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among Austria for the period between January 2010 and December 2019. Demographic, peri- and postoperative data of patients were analyzed retrospectively.

Participants needed: 3,446
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Barmherzige Brüder ViennaUpdated: Aug 14, 2024Locations: 1
Eligibility criteria

Patients with benign or malignant diseases in the right portion of the colon. [+1]

emergent surgery

Status: Recruiting

Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

The goal of this observational study is to learn about the best indications and techniques regarding endoscopic vacuum therapy (EVT) in patients with a transmural defect in the upper gastrointestinal (GI) tract (e.g. anastomotic leakage, Boerhaave syndrome, iatrogenic perforation, other). The main questions it aims to answer are: * What is the success rate of EVT for transmural defects in the upper GI tract? * What are the best indications for EVT in the upper GI tract? (e.g. etiology, patient characteristics, defect characteristics) * What are the best techniques for EVT in the upper GI tract? (e.g. EsoSponge, VACStent, vacuum pressure, intraluminal/intracavitary) Participants will be asked for informed consent to retrospectively and prospectively collect data on EVT.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Updated: Jul 23, 2024Locations: 1Duration: 6 Months
Eligibility criteria

Treated with EVT for anastomotic leakage after esophago-gastric surgery [+2]

No signed informed consent

Status: Not yet recruiting

Quantification of Anastomostic Blood Flow With Fluorescence Imaging in Low Anterior Resection for Rectal Cancer

A serious and life-threatening complication to rectal surgery is anastomotic leakage, AL. In Denmark, approximately 800 patients every year, are operated for rectal cancer, 50% of these with resection and anastomosis. The registered leakage rate for rectal anastomosis is 10-15%. AL can be life threatening and has long-term adverse effects for the patients, with reduced quality of life, due to a poor functional result of the neo-rectum known as low anterior rectal syndrome (LARS). Fistulas to the vagina or urinary tract are other severe complications. Furthermore, AL is associated with an increased risk of reccurence1. Finally, the AL-associated morbidity is also a significant economic burden to the health care system due to prolonged hospital stay, medicine, and reoperations. During surgery it is important to ensure optimal healing conditions for the anastomosis. The blood flow is evaluated by colour and pulsation in the mesentery. Studies suggest that it might be easier to evaluate the perfusion using fluorescent dye. This evaluation is a subjective evaluation, based mostly on the surgeon's experience. Assessing fluorescence by computer-based software, qICG, has been developed. But cut-off values for sufficient blood flow to diminish the risk of leakage, has not yet been defined. Aim: Primary objective: To establish cut-off values of qICG, where blood flow assumes sufficient for healing, and thereby reduce the risk of leakage. Secondary objective: To identify which long-term complications grade A, B and C leakages entails on Quality of Life.

Participants needed: 168
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Odense University HospitalUpdated: Nov 28, 2022Locations: 1Duration: 1 Year
Eligibility criteria

Patients, older than 18, undergoing laparoscopic or robotic surgery for rectal c...

Allergy of iodide. Terminal renal disease. Pregnancy. Lactation. Previous left s...