Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Hemorrhage

Intestinal Diseases

Inflammatory Bowel Diseases

Colonic Neoplasms

Prolapse

Rectal Neoplasms

Diverticulitis

Constriction, Pathologic

Rectal Prolapse

Anastomotic Leak

Gastrointestinal Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Diverticulum

Diverticular Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Colonic Diseases

Pelvic Organ Prolapse

Restoring intestinal continuity using the NITI CAR27 device

Compression Anastomosis Device

endoscopic exploration of anastomosis after complete healing

follow-up colonoscopy

Friedrich Herbst, MD, FRCS

After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.

NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

Compression Anastomosis: Initial Clinical Experience With the ColonRingTM

St John of God Hospital, Vienna

Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device

follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing

NITI CAR27 (ColonRing)

Age, Continuous

Sex: Female, Male

Bernhard Dauser (MD)

Anastomotic Leakage

Clinical Relevant Stenosis

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Nervous System Diseases

Wounds and Injuries

Rare Diseases

Esophageal Neoplasms

Recurrence

Laryngeal Nerve Injuries

Recurrent Laryngeal Nerve Injuries

Disease Attributes

Head and Neck Neoplasms

Esophageal Diseases

Postoperative Complications

Laryngeal Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Vagus Nerve Injuries

Cranial Nerve Injuries

Cranial Nerve Diseases

Craniocerebral Trauma

Trauma, Nervous System

Esophageal Cancer

No intervention

Zhigang Li, Doctor

Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. Analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury.

Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation

Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation: a Prospective, Observational, Non-interventional Study

hoarseness symptoms, recovery progression of recurrent laryngeal nerve injury

Shanghai Chest Hospital

Deputy director of department of thoracic surgery

Herbal and Botanical

All Drugs and Chemicals

Cola

Colorectal anastomosis is created with a two-row circular surgical stapler

Colorectal anastomosis is created with a three-row circular surgical stapler

Para-aortic lymph node dissection, inferior mesenteric artery skeletonisation and ligation below left colic artery origin, nerve-preserving total mesorectal excision, rectum division with a linear stapler, sigmoid colon division and circular stapler envil fixation with a purse-string suture, end-to-end colorectal anastomosis creation with a three-row circular stapler, defunctioning colostomy is performed.

Three-row circular stapler

Para-aortic lymph node dissection, inferior mesenteric artery skeletonisation and ligation below left colic artery origin, nerve-preserving total mesorectal excision, rectum division with a linear stapler, sigmoid colon division and circular stapler envil fixation with a purse-string suture, end-to-end colorectal anastomosis creation with a two-row circular stapler, defunctioning colostomy is performed.

Two-row circular stapler

Inna Tulina, MD

Nikita Nekliudov

Nikita Neklyudov, MD

Petr Tsarkov, MD

This trial aims to assess safety and efficacy of three-row circular staplers compared to two-row surgical stapllers in short-term and long-term perspective in patients with rectal cancer undergoing low anterior resection with stapled colorectal anastomosis. All the patients will undergo a low anterior resection. In a half of patients a colorectal anastomosis will be created with a three-row surgical circular stapler. In another half of patients a colorectal anastomosis will be created with a two-row surgical circular stapler.

A low anterior resection for rectal cancer in most cases results in creating a colorectal anastomosis with a surgical circular stapler device. Using a disposable circular stapler with two rows of staples is standard of care nowadays. Colorectal anastomosis dehiscence and subsequent anastomotic leak in postoperative period happens in 5-25% of cases and is a major and life-threatening complication. Thus different improvements to the procedure of creating a colorectal anastomosis are being proposed. One of them is utilizing a three-row instead of a two-row surgical circular stapler.

A three-row surgical stapler has recently been registered and approved for clinical use in Russia. The primary purpose of this study is to find out the rate of colorectal anastomosis leakage when using a three-row circular stapler and to demonstrate that it is at least not bigger than the rate of colorectal anastomosis leakage when using a two-row circular stapler.

THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer

Uni-center, Patient-blinded, Randomized, 12 Month, Parallel-group, Non-inferiority Study to Compare Outcomes of Three-row Versus Two-row Circular Staplers for Colorectal Anastomosis Formation After Low Anterior Resection for Rectal Cancer

The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan

The duration of surgical procedure in minutes

The rate of circular stapler inability to create a colorectal anastomosis in a way declared by the manufacturer

The rate of bleeding from the line of stapled anastomosis verified by proctoscopy

The rate of repeat surgeries due to anastomotic leakage

The rate of complications in first 30 days after surgery

The number of days from the first day after operation to discharge

The rate of complications related to defunctioning stoma

Assessed with patient-reported questionnaire SF-36. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability

Assessed with patient-reported questionnaire EORTC QLQ-C30 with supplementary module EORTC QLQ-CR29. A total score in each of 4 modules (functional scale, global health status, symptom scale, colorectal cancer module) will be calculated and transformed into a 0-100 scale. For Functional scale, Global health status scale and Colorectal cancer module a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. For Symptom scale a score of 100 is equivalent to maximum disability and a score of 0 is equivalent to no disability.

Assessed with patient-reported questionnaire LARS, total score will be calculated (min 0, max 42) for each patient and also each patient will be assigned to either "no LARS" group (total score 0-20), or "minor LARS" group (total score 21-29) or "major LARS" group (total score 30-42)

The rate of adverse events related to circular stapler usage

The rate of serious adverse events related to circular stapler usage

Meril Life Sciences Pvt. Ltd.

I.M. Sechenov First Moscow State Medical University

Russian Society of Colorectal Surgeons

Head of Oncologic Colorectal Surgery Department, Clinic of Colorectal and Minimally Invasive Surgery

without any intervention, patients diagnose as anastomotic stricture after rectal cancer surgery

without any intervention, patients does not diagnose as anastomotic stricture after rectal cancer surgery

without any intervention

Background: Anastomotic stricture significantly impacts patients' quality of life and long-term prognosis. However, current clinical practice lacks accurate tools for predicting anastomotic stricture. This study aimed to develop a nomogram to predict anastomotic stricture in patients with rectal cancer who have undergone anterior resection.

Methods: 1542 eligible patients will be recruited for the study. Least absolute shrinkage selection operator (Lasso) analysis will be used to preliminarily select predictors. A prediction model will be constructed using multivariate logistic regression and presented as a nomogram. The performance of the nomogram will be evaluated using receiver operating characteristic (ROC) curves, calibration diagrams, and decision curve analysis (DCA). Internal validation will be conducted by assessing the model's performance on a validation cohort.

A Prediction Model of Anastomotic Stricture After Rectal Cancer

A Prediction Model of Anastomotic Stricture After Rectal Cancer: a Retrospective Cohort Analysis

Within six months after rectal cancer surgery, the patient was diagnosed with benign stricture of the rectal anastomosis

Within six months after rectal cancer surgery, the patient was not diagnosed with benign stricture of the rectal anastomosis

Northern Jiangsu People's Hospital

Clinical Professor

Carcinoma

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Yusen Cheng, MB

Yong Zhou, MD, PhD

Yong Zhou, PhD

The purpose of this study is to explore the clinical application value of Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers.

As one of the core contents of gastric cancer surgery, the choice of digestive tract reconstruction method has always been the focus of clinical research in gastric cancer surgery. There are many alternative methods of digestive tract reconstruction at present, but there is no absolute superiority among various reconstruction methods. According to the individual characteristics of patients, the selection of appropriate digestive tract reconstruction methods should be an important direction in the future research field of digestive tract reconstruction.

There are many methods of digestive tract reconstruction in distal gastrectomy, including Billroth-I anastomosis, Billroth-II anastomosis and Roux-en-Y anastomosis. However, the standard method of reconstruction after distal subtotal gastrectomy does not reach a consensus. According to Korean Practice Guideline for Gastric Cancer 2018, gastroduodenostomy and gastrojejunal anastomosis are recommended after distal subtotal gastrectomy for middle-low gastric cancer, but the priority of different surgical procedures is not clarified. The conclusion is that there is no significant difference between the Billroth-I, Billroth-II and Roux-en-Y in postoperative quality of life, nutritional status and long-term prognosis of patients. Roux-en-Y anastomosis has a lower incidence of bile reflux, but a higher incidence of delayed gastric emptying compared with Billroth-I and Billroth-II. Similarly, the Japanese gastric cancer treatment guidelines in 2018 did not specify the priority of reconstruction methods after distal gastrectomy. In China, the 2022 CSCO guidelines for the diagnosis and treatment of gastric cancer also did not specify the priority of reconstruction methods, pointing out that alternative reconstruction methods include Billroth-I, Billroth-II combine with Braun anastomosis, Roux-en-Y anastomosis, and jejunal interposition. However, the number of alternative methods indicates that no ideal reconstruction method has absolute advantages. Therefore, in clinical practice, the specific choice of digestive tract reconstruction method often needs to be determined by considering many factors, including the location of the primary tumor, tumor stage, lymph node condition, anatomical variation and patient's economic situation, etc., which are important factors affecting the choice of digestive tract reconstruction method.

With the development of laparoscopic technique in recent years, totally laparoscopic digestive tract reconstruction has become a hot spot in the surgical treatment of gastric cancer. Laparoscopic digestive tract reconstruction has smaller incision and less trauma, which is a higher-level laparoscopic surgery pursued by surgeons. However, for patients undergoing radical gastrectomy for distal gastric cancer, totally laparoscopic distal gastroduodenal anastomosis is technically difficult. Delta anastomosis was proposed by Professor Kannaya in Japan in 2002. In this technique, the functional end to end anastomosis of the posterior wall of the remnant gastroduodenal was completed by using endoscopic linear staplers under totally laparoscopy, and the suture nails inside the anastomosis were triangular. It is a widely used functional end to end anastomosis of remnant gastroduodenum after distal gastrectomy under totally laparoscopic surgery. However, because of the operation in the duodenum and stomach from broken should meet the requirements of R0 resection of tumor, proper anastomotic tension, and blood supply of free longer duodenal stump, its restrictive factors, poor controllability, security is still not widely recognized, it can only be carried out in centers with rich experience in laparoscopic surgery, and it is more suitable for early cases of gastric Antrum.

In 2016, Professor Changming Huang found that modified Delta anastomosis is safe and feasible in early gastric cancer, but caution is still needed for locally advanced gastric cancer, its incidence of postoperative complications and anastomotic leakage was significantly higher than that of laparoscopic-assisted Billroth-I anastomosis.

In 1995, Oka et al. reported the use of circular stapler for functional end to end anastomosis of remnant gastroduodenum in open distal gastric cancer radical resection. In 2004, they reported the results of 221 cases, showing that this anastomosis was clinically safe and reliable. In 2007, Yang et al. in Korea confirmed that functional end to end anastomosis was safe and feasible in 933 cases of distal gastric cancer, with similar short-term outcomes compared with Billroth-II anastomosis. However, the clinical staging of gastric cancer patients in Japan and Korea is mainly early stage, but in China, the clinical staging of gastric cancer patients is mostly advanced stage.

In conclusion, traditional Billroth-I end-to-side anastomosis and Delta anastomosis require an additional residual gastric tissue of at least 3cm. In addition, the safe margin of the broken end of advanced gastric cancer requires a distance of at least 3-5 cm from the tumor, which often leads to higher anastomotic tension and significantly increases the risk of anastomotic leakage. Therefore, we propose a new technique for gastrointestinal reconstruction in laparoscopic distal radical gastrectomy in locally advanced gastric cancer: Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery. After previous practice, this anastomotic method can not only ensure a safe surgical margin, but also retain more residual stomach, so as to effectively solve the problem of anastomotic tension. It is a safe, simple, physiological and economic anastomotic method.

Prospective Study on Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers

Safety and Feasibility of Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers: A Prospective Cohort Study

The anastomotic complications are defined as the event observed within 30 days after surgery, including anastomotic stenosis, anastomotic bleeding, and anastomotic leakage.

Operation time, anastomotic reconstruction time, operative blood loss, completed proportion of laparoscopic surgery, positive rate of Intraoperative frozen margin pathology, anastomotic tension, the distance between proximal and distal of resection margin, the incidence of complication in surgery are used to access the intraoperative situation.

The variation of weight, cholesterol and albumin on postoperative 30 days are used to access the postoperative nutritional status and quality of life.

The time between end of surgery and written discharge ticket

The fees paid during the course of this hospitalization

Other postoperative complications are defined as events other than anastomotic complications occurring within 30 days after surgery.

The time between end of surgery and first bowel movement

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery	NCT01056913	Colonic Neoplas... Rectal Neoplasm... Diverticulitis Inflammatory Bo... Rectal Prolapse	Compression Ana... follow-up colon...	18 Years - 90 Years	St John of God Hospital, Vienna
Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation	NCT06348381	Esophageal Neop... Anastomotic Lea... Recurrent Laryn... Anastomotic Ste... Endoscopic Eval...	No intervention	18 Years - 80 Years	Shanghai Chest Hospital
THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer	NCT03910699	Anastomotic Lea... Anastomotic Hae... Anastomotic Com... Rectal Neoplasm... Staple Misfire Anastomosis Anastomotic Ste...	Three-row circu... Two-row circula...	18 Years - 85 Years	Russian Society of Colorectal Surgeons
Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation	NCT06348381	Esophageal Neop... Anastomotic Lea... Recurrent Laryn... Anastomotic Ste... Endoscopic Eval...	No intervention	18 Years - 80 Years	Shanghai Chest Hospital
Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation	NCT06348381	Esophageal Neop... Anastomotic Lea... Recurrent Laryn... Anastomotic Ste... Endoscopic Eval...	No intervention	18 Years - 80 Years	Shanghai Chest Hospital
A Prediction Model of Anastomotic Stricture After Rectal Cancer	NCT06404554	Colorectal Canc... Rectal Cancer Anastomotic Ste...	without any int...	18 Years - 80 Years	Northern Jiangsu People's Hospital
A Prediction Model of Anastomotic Stricture After Rectal Cancer	NCT06404554	Colorectal Canc... Rectal Cancer Anastomotic Ste...	without any int...	18 Years - 80 Years	Northern Jiangsu People's Hospital
Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation	NCT06348381	Esophageal Neop... Anastomotic Lea... Recurrent Laryn... Anastomotic Ste... Endoscopic Eval...	No intervention	18 Years - 80 Years	Shanghai Chest Hospital
Prospective Study on Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers	NCT05545293	Advanced Gastri...		18 Years - 85 Years	West China Hospital

Spots Global Cancer Trial Database for anastomotic stenosis