Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colonic Neoplasms

Rectal Neoplasms

Diverticulum

Diverticular Diseases

Diverticulosis, Colonic

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Anti-Infective Agents

All Drugs and Chemicals

Ertapenem

Anti-Bacterial Agents

powder for infusion, 1 gram I.V., single dose over 30 min.

Doris Henne-Bruns, Prof. Dr.

The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.

The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.

Concentration of Ertapenem in Colorectal Tissue

Konzentrationen Von Ertapenem in Kolorektalem Gewebe

The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours

University of Ulm

Administration of 1 gram ertapenem I.V.

Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.

Age, Categorical

Age, Continuous

Gender

Germany

Region of Enrollment

Prof. Dr. Henne-Bruns, PI

Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..

Safety Assessment

Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue

Overall Study

Crohn Disease

Inflammatory Bowel Diseases

Patients accept the management of Biodegradable Stenting Anastomoses for reconstruction in the surgery of Intestinal Anastomosis

Patients accept the management of Double-layer Hand Sutures for reconstruction in the surgery of Intestinal Anastomosis

Biodegradable Stenting Anastomoses(BSA) is a new method and device which helps to make intestinal anastomosis easily. According to the measurement of intestinal canal diameter, chose an appropriate size of BSA and use the Seromuscular layer Purse-string Suture to stitch with an absorbable line (VCP311, Ethicon, Inc.) away from the end 0.5 to 1.0 cm and not knot temporarily, then open and sterilize intestinal canal fully, and place the BSA into the intestinal canal at appropriate position before tightening knot. Last, the interrupted whole layer inversion suture is used to fix.

Biodegradable Stenting Anastomoses

Double-layer Hand Sutures(DHS)is a surgery way that is to use the single-layer continous Hand Sutures,then Lembert to stitch with an absorbable line (VCP311, Ethicon, Inc.).

Double-layer Hand Sutures

Guocong Wu, Doctor

Zhongtao Zhang, Doctor

Intestinal anastomosis plays an important role in various general surgeries, but the complications such as anastomotic leakage,stenosis and hemorrhage cannot been avoided. Although many ways are put up to solve this problem, there are still many imports need to improve. Therefore, the Biodegradable Stenting Anastomoses(BSA), which make intestinal anastomosis easily and less complications, have been produced.The major goal of this study is to evaluate the efficacy of Biodegradable Stenting Anastomoses(BSA) for reconstruction in surgery of intestinal anastomosis.

Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Intestinal Anastomosis

Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Surgery of Intestinal Anastomosis: A Multicenter, Prospective Cohort Study

The patients with anastomotic leakage / the total patients. The definition of anastomotic leakage in this study, is included one of the situation as follows: (1) peritonitis caused by leakage, pelvic abscess without radiologically proven anastomotic leakage were considered as equivalents of clinically anastomotic leakage as defined above.; (2) Discharge of faeces, pus or gas from the abdominal drain; (3) All anastomotic leakages were confirmed by one or more of the following methods such as CT scan, ultrasonography and laparotomy.

The patients with anastomotic hemorrhage / the total patients. Anastomotic bleeding was considered gastrointestinal bleeding after surgery, and it ascertains that the bleeding is from anastomosis with endoscopy.

The patients with anastomotic stenosis / the total patients.Anastomotic stenosis which is not caused by tumor in the patients with complete or incomplete intestinal obstruction symptoms.

Number of participant with abnormal laboratory values will be record. Laboratory tests include Blood routine/Coagulation/Liver and renal function/Electrolyte/Lipids/OB. Abnormal laboratory values means that values of Laboratory tests beyond the normal values.

Severe adverse events (SAEs) refer to the following conditions: death, life-threatening or permanent or significant disability, permanent functional injury to the organs, hospitalization for emergencies or prolonged hospitalization

The enteroscopy will be used to observe whether the Biodegradable Stenting Anastomoses be eliminated from body at 4th weeks after surgery.If Biodegradable Stenting Anastomoses be eliminated, contrast will be filling defect.

The time of reconstruction in the surgery of Intestinal Anastomosis for each group is recorded, which is from the beginning to the ending of Intestinal Anastomosis

Peking University Third Hospital

Zhejiang Cancer Hospital

Beijing Friendship Hospital

Doctor

Pharmaceutical Solutions

Analgesics

Central Nervous System Depressants

Herbal and Botanical

Morphine

Nefopam

Analgesics, Non-Narcotic

Cola

The nefopam group received 120 mg nefopam (Acupan, Pharmbio, France) by continuous iv infusion over the study period (48h)

The Control group received 120 mg placebo infusion (saline solution) by continuous iv infusion over the study period (48h).

saline solution

Jacques RIPART, Dr

This study analyses interest of iv nefopam in combination with paracetamol after major abdominal surgery because the effect of morphine-sparing is discussed when combined these agents.

Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery

Centre Hospitalier Universitaire de Nīmes

Anastomotic Leak

Postoperative Complications

Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.

Standard colorectal surgery and anastomosis.

The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.

ICG fluorescence imaging

Jyrki Kössi, MD, PhD

Olli Helminen, MD, PhD

Heikki Huhta, MD, PhD

Juha Rinne, MD

Matti Kairaluoma, MD, PhD

Tero Rautio, MD, PhD

This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.

Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

Grade A-C according to International Study Group of Rectal Cancer

Clavien-Dindo Score from Grade 0 (no complications) to Grade V (Death of a patient). Five grades and additionally Grade III and IV will be divided to a and b.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Concentration of Ertapenem in Colorectal Tissue	NCT00535652	Diverticulosis,... Rectal Neoplasm... Colonic Neoplas...	Ertapenem	18 Years - 90 Years	University of Ulm
Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Intestinal Anastomosis	NCT02752360	Colonic Neoplas... Diverticulosis,... Crohn Disease	Biodegradable S... Double-layer Ha...	18 Years - 80 Years	Beijing Friendship Hospital
Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery	NCT03619538	Colonic Neoplas... Diverticulosis,...	Nefopam saline solution	18 Years -	Centre Hospitalier Universitaire de Nīmes
Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery	NCT03619538	Colonic Neoplas... Diverticulosis,...	Nefopam saline solution	18 Years -	Centre Hospitalier Universitaire de Nīmes
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage	NCT03602677	Colorectal Canc... Colorectal Neop... Gastrointestina... Gastrointestina... Diverticulosis,... Gastrointestina...	ICG fluorescenc...	18 Years -	Oulu University Hospital

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