Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Adenoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Herbal and Botanical

Metformin

Cola

Patients randomized to Metformin-ER 500 mg once daily for one week and then escalation to 1000 mg/day for the duration of the trial. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days.

Patients will not receive any study drug from the time of colonoscopy until surgery.

500 mg by mouth once daily, beginning the day after colonoscopy for one week, and then escalation to 1000 mg/day. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days.

Metformin ER

Patrick Lynch, MD, JD

The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied.

Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is also designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.

* If you are in Group 1, you will receive metformin ER. You will have a 2 in 3 chance of being assigned to Group 1.
* If you are in Group 2, you will receive no treatment. You will have a 1 in 3 chance of being assigned to Group 2.

Study Drug Administration:

If you are in Group 1, You will start taking the drug the day after your colonoscopy (or later if your surgery is scheduled to be more than 30 days after the colonoscopy) and will continue to take it until your scheduled surgery (for up to 30 days). During the first week you will take one tablet of metformin-ER by mouth one time each day with food. From the beginning of the second week until your scheduled surgery, you will take two tablets of metformin-ER by mouth one time each day with food. If you have side effects, your dose may be lowered.

If you are in Group 2, you will not receive any study drug from the time of your colonoscopy until surgery.

Study Visits:

On the day of your colonoscopy:

* Your medical history will be recorded and you will be asked about any drugs you may be taking.
* You will have a physical exam.
* Extra tissue samples will be collected during the colonoscopy for routine and biomarker testing. Biomarkers are small pieces of material or substances found in you tissue that may provide information about your condition or the disease.
* The study staff will call you 1 week after your colonoscopy and ask about your general health and about any side effects you may be having.

On the day before surgery or the day of the surgery itself:

* Your weight will be measured.
* Blood (about 3 tablespoons) will be drawn for routine tests and for research about the safety of metformin-ER and how it may affect the disease. This routine blood draw will include a pregnancy test if you are able to become pregnant.
* You will be asked about your general health and about any side effects you may be having.
* During the surgery, extra tissue samples will be collected for biomarker testing.

Length of Study:

You will be on study for up to 30 days. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have had the surgery.

This is an investigational study. Metformin-ER is FDA approved and commercially available for the treatment of type 2 diabetes. Its use in this study is investigational.

Up to 23 patients will take part in this study. All will be enrolled at MD Anderson.

An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin

An Open-Labeled Pilot Study of Biomarker Response in Patients With Colorectal Cancer or Endoscopically Non-Resectable Adenomas Following Short-Term Exposure to Metformin Extended Release (ER)

Primary outcome measure is change in the percentage of Ki67-positive-staining cells between the baseline colonoscopy and surgery in the colon rectal cancer/non-resectable adenoma samples.

M.D. Anderson Cancer Center

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Acute Graft Versus Host Disease

Central Nervous System Depressants

Analgesics

Anesthetics

Analgesics, Opioid

Narcotics

Patients undergoing CES and general anesthesia in colon cancer surgery

Patients undergoing general anesthesia in colon cancer surgery

electrotherapy

consumption of opioids during general anesthesia

Opioid Anesthetics

colon cancer surgery

Yi-hsuan Huang, MD

Cranial electrotherapy stimulation (CES) is a non-invasive intervention to treat anxiety, depression, insomnia, and pain. But clinical studies and applications of CES in relation to acute postoperative pain are few. tThe investigators investigate a double-blind, randomized controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon cancer surgery.

Cranial electrotherapy stimulation (CES) is a non-invasive and safe intervention, transmitting microcurrents of brain stimulation and releasing various neurotransmitters such as endorphin and downstream hormones to modulate autonomic nervous system, as a result, for treating anxiety, depression, insomnia, and pain.

Acute postoperative pain annoys patients receiving surgery. Once acute postoperative pain is poorly controlled, it may result in adverse acute effects (i.e., physiologic and psychologic stress), chronic effects (i.e., delayed long-term recovery and chronic pain), and, in consequence, excess length of hospitalization and extra costs. Besides, inflammatory reactions mediated by immune system are formed after tissue injury (e.g. trauma, surgery, etc), release serial inflammatory cytokines and are related to pain signal transmission. However, clinical studies and applications of CES focus on management of chronic pain, modulation of mood and insomnia rather than acute postoperative pain in recent years.

The investigators investigate a double-blind, randomized controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon cancer surgery. The investigators also collect blood samples before and after surgery for analysis of serum cytokines. Meanwhile, Bispectral IndexTM (BISTM) monitoring and Analgesia Nociception Index (ANI) are prescribed during the surgery not only for measuring of the effects of anesthetics and sedatives on the brain, but also evaluating perioperative analgesia. Thereby, the effectiveness of CES for management of acute postoperative pain may introduce clinicians for alternative application of pain control after surgery in the future.

Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain

Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery

The consumption of total amount of supplemental analgesics administered during colon cancer surgery

The consumption of total amount of rescue analgesics administered after colon cancer surgery

Pain assessment of NRS pain intensity scores and patient satisfaction assessed by the NRS through end of surgery to postoperative 72 hours

proinflammatory and antiinflammatory cytokines (IL-1a, IL-2, IL-6, IL-7, TNF-a, IL-4, IL-10, IL-10, IL-1, TGF-b)

Tri-Service General Hospital

Attending Physician

Recurrence

Neoplasm, Residual

Colonic Neoplasms

Neoplastic Processes

Adjuvants, Anesthesia

Sufentanil

Bupivacaine

Morphine

Dsuvia

Pirinitramide

Patients will receive perioperative epidural analgesia. Drugs: bupivacaine 1.25 mg/ml and sufentanil 0.5 mcg/ml Form and frequency: continuous infusion Dosage: 4 - 14 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required

Patients will receive postoperative analgesia with piritramide. Drugs: piritramide 1.0 mg/ml Form and frequency: continuous infusion Dosage: 0 - 4 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required

Patients will receive postoperative analgesia with morphine. Drugs: morphine 1.0 mg/ml Form and frequency: continuous infusion Dosage: 0 - 4 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required

Epidural analgesia

Piritramide

Emil Berta, MD PhD

The aim of this study is to compare the effects of three types of perioperative analgesia on the number of circulating cancer cells (representing minimal residual disease) following radical colon cancer surgery. Patients will be randomized into one of three groups. The intervention group will receive combined regional and general anesthesia during surgery and postoperative epidural analgesia. The two control groups will receive balanced general anesthesia and either morphine-based or piritramide-based postoperative analgesia. We hypothesize that epidural analgesia will be favorable to both piritramide-based and morphine-based analgesia and that piritramide-based analgesia will be favorable to morphine-based analgesia with regard to the number of circulating cancer cells and its development in the early postoperative period.

Techniques of regional analgesia such as epidural analgesia may favorably influence metastasis development following cancer surgery compared to analgesia based on strong opioids such as morphine or piritramide. These beneficial effects, if present, are probably attributable to less immunosuppression of antimetastatic immune defenses.

The aim of this study is to identify techniques of perioperative analgesia with the potential to prevent metastasis development in patients undergoing open radical colon cancer surgery. In the early postoperative period, a relationship between metastasis development and the number of circulating cancer cells representing minimal residual disease has been shown. Therefore, effects of epidural, morphine-based and piritramide-based analgesia on the number of circulating cancer cells will be compared at several time points during the peroperative and early postoperative periods. The number of circulating cancer cells will be assessed in peripheral venous blood samples using real-time polymerase chain reaction. Perioperative care will be standardized and patients will be followed by clinical observation, laboratory analyses and monitoring instrumentation daily during their hospital stay.

Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery

Number of circulating cancer cells will be measured in venous blood samples. The quantitative real-time polymerase chain reaction using carcinoembryonic antigen and cytokeratine 20 as markers for circulating cancer cells will be used for minimal residual disease detection.

Self reported pain intensity. Scale: 0 = no pain, 10 = worst pain imaginable. A score 0-10 will be recorded every four hours.

Brno University Hospital

Tomas Bata Hospital, Czech Republic

The Institute of Molecular and Translational Medicine, Czech Republic

Senior Researcher

Behaviors and Mental Disorders

Quality of Life

laparoscopic surgery in right colon cancer operations

open surgery in right colon cancer operations

Laurent Hannoun, MD, PhD

The primary goal of this study is to compare in the long-term costs of laparoscopic or open right colectomy in patients sustaining a colon cancer controling for the carcinologic equivalence of the two surgical strategies. The secondary goals to compare long-term mortality, morbidity as well as quality of life of the two groups.The present study is an prospective multicentric observational trial taking into account the usual surgical strategy of every centers

The aim of the present study is to compare in the long-term costs of laparoscopic and open right cancer colectomy as well as the mortality the morbidity and the quality of life of the operated patients.

The number of patients need to get a 54% power is 300. The average number of patients/surgical center is approximately 27 in 14 surgical centers.

The proposed undertaking of every patient is fully identical to that which is usually proposed by the surgical center in charge of the patient (i.d. 7 centers will perform laparoscopic procedures and 7 centers open procedure according to their usual practice).

A complete information leaflet will be given to the patients during the first consultation which will correspond to the enrollment day.

The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.

The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.

The follow-up encompass 5 postoperative consultations:1 month, 6 ,12 ,18 and 24 months.

On every consultation the patient will fill a very simple validated quality of life questionnaire (EORTC,QLQ.C30) an give back a weekly journal reporting the potentially arising medical and surgical events.

Globally the comparative analysis of the costs ,the mortality ,the morbidity, the quality of life ot the patients undergoing either a laparoscopic or a open right colectomy for cancer will be performed controling for the carcinologic equivalence of the two surgical strategies.

Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery?

Right Colon Cancer: Laparoscopic Surgery Versus Open Surgery, Costs, Mortality, Morbidity and Quality of Life

Assistance Publique - Hôpitaux de Paris

Infections

Communicable Diseases

Surgical Wound Infection

Anti-Infective Agents

Gastrointestinal Agents

Anti-Bacterial Agents

Ornidazole

Antibiotics, Antitubercular

Gentamicins

Sennosides

Enzyme Inhibitors

Laxatives

Cathartics

Amebicides

Antiprotozoal Agents

Antiparasitic Agents

Senna

Sennosides colonic preparation Oral Gentamycin Oral Ornidazole

* Sennosides colonic preparation (X-PREP) :

  1 per day, on day -2 and day -1.
* Gentamycin :

  80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
* Ornidazole :

  1. g per day (2 tablet per day), on day -2 and day -1; In tablets.

Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole

* Sennosides colonic preparation (X-PREP) :

  1 per day, on day -2 and day -1.
* Placebo for oral gentamycin:

Same presentation as oral gentamycin x4 per day on day -2 and day -1. - Placebo for oral ornidazole : Same presentation as oral ornidazole

1g per day (2 tablet per day) on day -2 and day -1.

Oral Gentamycin Oral Ornidazole

* Gentamycin :

  80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
* Ornidazole :

  1. g per day (2 tablet per day), on day -2 and day -1; In tablets.

Oral placebo Gentamycin Oral placebo Ornidazole

- Placebo for oral gentamycin : Same presentation as oral gentamycin x4 per day on day -2 and day -1

- Placebo for oral ornidazole : Same presentation as oral ornidazole

1g per day (2 tablet per day) on day -2 and day -1

Mechanical bowel preparation :

Sennosides colonic preparation (X-PREP)

1 per day, on day -2 and day -1

Sennosides colonic preparation

Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials

Oral Gentamycin

Oral Ornidazole :

Ornidazole

1 g per day (2 tablet per day), on day -2 and day -1; In tablets

Oral Ornidazole

Placebo for oral gentamycin :

Same presentation as oral gentamycin x4 per day on day -2 and day -1

Oral placebo Gentamycin

Placebo for oral Ornidazole :

Same presentation as oral ornidazole

1g per day (2 tablet per day) on day -2 and day -1

Oral placebo Ornidazole

This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

Preoperative mechanical bowel preparation (MBP) has been proposed in an attempt to reduce the colonic fecal load and to limit the risk of surgical site contamination, thus theoretically limiting the risk of postoperative SSI. However, several randomized-controlled trials (RCT) and meta-analyses, have suggested the absence of benefit, in term of postoperative morbidity, of preoperative MBP before elective colon cancer surgery. A meta-analysis of RCT, comparing MBP to no-MBP before elective colon cancer surgery, even suggested that MBP could be associated with an increased SSI rate, as compared to no-MBP. These results led the latest French surgical guidelines of the Société Française de Chirurgie Digestive (SFCD) to recommend the absence of MBP before elective colon cancer surgery.

However, recent studies suggested that the adjunction of oral antibiotics during MBP could help efficiently reduce the risk of postoperative SSI. Indeed, a recent meta-analysis of RCT have suggested that patients preoperatively receiving both MBP and oral antibiotics were exposed to a significantly reduced risk of postoperative SSI, as compared to patients receiving only preoperative MBP. This result was confirmed in a recent RCT which compared preoperative MBP and oral antibiotics versus MBP alone in a heterogeneous population of patients who underwent laparoscopic colonic or rectal surgery. This latter study reported a 50% reduction of SSI rate in the "MBP and oral antibiotics" group, as compared to the "MBP alone" group. Finally, three recent large retrospective registry studies compared the outcomes of four different strategies of preoperative colonic preparation before colorectal surgery: 1) MBP and oral antibiotics, 2) MBP alone, 3) Oral antibiotics alone, and 4) No colonic preparation. However, to date, no RCT has compared the "No preparation" group, which is the gold standard according to the international and French guidelines, to the "MBP and oral antibiotics" group.

The present study is therefore the first double-blinded RCT to compare the SSI rate for 4 types of colonic preparation before elective laparoscopic colonic surgery: 1) MBP and oral antibiotics, 2) MBP alone, 3) Oral antibiotics alone, and 4) No preparation.

Double Blind : both participants and investigators are unaware of the intervention assignment

Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery

Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (COLONPREP Study)

There is not a plan to make IPD available

SSI will be defined and classified as superficial, deep and/or organ-space infection on the basis of validated and well-defined criteria developed by the Centers for Disease Control and Prevention (CDC), validated in French by the Comité technique des infections nosocomiales et des infections liées aux soins

Including all postoperative complications occurring within 30 days after surgery, defined and classified according to the Clavien-Dindo classification.

Including all complications graded 3 or more according to the Clavien-Dindo classification, and occurring within 30 days after surgery.

Including all deaths occurring within 30 days after surgery.

Defined as the passing of any intra-colonic content (air, liquid, intestinal content, or radiological contrast) through an anastomosis or by an peri-anastomotic abscess, even in the absence of intra-colonic content leak through the anastomosis, observed in drainages, surgical incision, vagina, during a surgical procedure or on a radiological examination, occurring within 90 days after surgery.

Calculated from the day of surgery to the day of hospital discharge.

Defined as any unplanned hospitalization between surgery and postoperative day 90.

Evaluated using a dedicated tolerance of the colonic preparation questionnaire performed the evening before surgery.

Defined as clinical symptoms of clostridium difficile colitis with at least 1 stool sample positive for Clostridium difficile toxin A/B as detected by enzyme-linked immunosorbent assay within 30 days after surgery.

Defined as rate of multi-resistant bacteria carriage

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin	NCT01816659	Colorectal Carc...	Metformin ER	18 Years - 75 Years	M.D. Anderson Cancer Center
Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain	NCT03825471	Opioid Use Cytokine	electrotherapy Opioid Anesthet... colon cancer su...	20 Years - 80 Years	Tri-Service General Hospital
Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery	NCT02314871	Colon Cancer Minimal Residua...	Epidural analge... Piritramide Morphine	18 Years -	The Institute of Molecular and Translational Medicine, Czech Republic
Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery?	NCT01772407	Colon Cancer		18 Years - 80 Years	Assistance Publique - Hôpitaux de Paris
Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery	NCT02314871	Colon Cancer Minimal Residua...	Epidural analge... Piritramide Morphine	18 Years -	The Institute of Molecular and Translational Medicine, Czech Republic
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery	NCT03475680	Colon Cancer	Sennosides colo... Oral Gentamycin Oral Ornidazole Oral placebo Ge... Oral placebo Or...	18 Years -	Assistance Publique - Hôpitaux de Paris
Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain	NCT03825471	Opioid Use Cytokine	electrotherapy Opioid Anesthet... colon cancer su...	20 Years - 80 Years	Tri-Service General Hospital
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery	NCT03475680	Colon Cancer	Sennosides colo... Oral Gentamycin Oral Ornidazole Oral placebo Ge... Oral placebo Or...	18 Years -	Assistance Publique - Hôpitaux de Paris
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery	NCT03475680	Colon Cancer	Sennosides colo... Oral Gentamycin Oral Ornidazole Oral placebo Ge... Oral placebo Or...	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for colon cancer surgery