Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Skin and Connective Tissue Diseases

Rare Diseases

Adenomatous Polyposis Coli

Syndrome

Recurrence

Crohn Disease

Surgical Wound

Polyps

Adenomatous Polyps

Peutz-Jeghers Syndrome

Intestinal Polyposis

Colonic Neoplasms

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Gastrointestinal Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Lentigo

Melanosis

Hyperpigmentation

Pigmentation Disorders

Skin Diseases

Familial Adenomatous Polyposis

MYH-associated Polyposis

Patients undergo single incision laparoscopic surgery with GelPort® attachment.

Undergo single incision laparoscopic surgery

therapeutic laparoscopic surgery

David Renton, MD

This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases

PRIMARY OBJECTIVES:

I. To report the experience of SILS procedure in the treatment of colorectal disease.

II. To standardize the SILS technique.

OUTLINE:

Patients undergo single incision laparoscopic surgery with GelPort® attachment.

After completion of study treatment, patients are followed up at 2 weeks, 3 and 6 months, and at 1 year.

Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach

Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).

Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

Ohio State University Comprehensive Cancer Center

Rectal Neoplasms

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Fluorouracil

Capecitabine

Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.

Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)

50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.

Concurrent chemotherapy:

Capecitabine 1650 mg/m2/d

Concurrent Chemoradiotherapy

Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 3 courses, 3 weeks per course

consolidation chemotherapy

Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 6-12 cycles

adjuvant chemotherapy

Sergey Sychev, Dr.Med.Sc

Sergey Sychev

Evgeny Rybakov, Dr.Med.Sc

This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.

In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint.

Total Neoadjuvant Therapy in Rectal Cancer Treatment

The rate of pathological or clinical complete responses

Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC)

Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification

State Scientific Centre of Coloproctology, Russian Federation

Head of Surgical department of oncoproctology

Colitis

Colitis, Ulcerative

Ulcer

Diverticulitis

Colonic Polyps

Pathological Conditions, Anatomical

Diverticulum

Diverticular Diseases

Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid

Hextend

Lactated Ringers

Anthony Senagore, MD

The purpose of this study is to find out if guided fluid administration with the esophageal monitor is superior to standard fluid administration and whether use of the hetastarch or lactated ringers offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.

An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy

A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid

Deltex Medical, Inc.

Spectrum Health Hospitals

Dr. Anthony Senagore

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Breast Neoplasms

Multiple Myeloma

Neoplasms, Plasma Cell

Peripheral Nervous System Diseases

Pain

Neuromuscular Diseases

Cisplatin

Bortezomib

Taxane

3 questionnaires to collect information about any pain and/or symptoms experienced, general well-being, and personal information such as age and marital status. One (1) will be a symptom assessment questionnaire where asked to rate symptoms on a scale of 0-10.

Questionnaire

Test of sensitivity to things such as cold and touch, involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board; and marking on computerized drawings areas experience pain, numbness, and/or cold sensitivity.

Sensory Tests

First 5 patients receiving platinum agents, taxanes, and bortezomib (15 patients total) will be asked to describe their symptoms in an open-ended, semi-structured 20-30 minute interview.

Interview

Charles Cleeland, PHD,BA

The goal of this research study is to learn more about pain and other symptoms that patients may experience while receiving chemotherapy treatment with platinum agents, taxanes, and/or bortezomib.

If patient agrees to take part in this study, they will be asked to complete 3 questionnaires, 3 sensory tests, and may be asked to take part in a one-on-one symptom interview.

Symptom Interview:

Depending on when patient is enrolled in this study, they may take part in a one-on-one interview with a study staff member. A total of 15 participants will take part in this interview (5 taking platinum agents, 5 taking taxanes, \& 5 taking bortezomib). During the interview, patient will be asked to describe their symptoms. The interview should take about 20-30 minutes to complete.

The interviews will be digitally recorded, transcribed (typed), and used by researchers to identify symptoms related to receiving this type of chemotherapy. Researchers will use this information to design a study questionnaire that focuses on chemotherapy symptoms in the hands and feet. The digital recordings and typed copies of the interview will be destroyed after researchers have analyzed the interview data and the study is complete.

Questionnaires \& Sensory Tests:

All study participants will complete 3 questionnaires that are designed to collect information about any pain and/or symptoms patient may have experienced, their general well-being, and personal information such as age and marital status. One (1) of them is called a symptom assessment questionnaire and patient be will asked to rate their symptoms on a scale of 0-10.

All study participants will also complete 3 tests, called sensory tests, that are designed to help researchers learn how sensitive patient is to things such as cold and touch. These tests involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board. Patient will also be asked to mark on computerized drawings the areas where they experience any pain, numbness, and/or cold sensitivity. A study staff member will explain how to take the tests and use the computerized drawings in more detail at the time these tests are performed.

It should take about 20-30 minutes to complete all of the questionnaires and tests.

Additional Sensory Testing:

Out of the 200 participants on this study, 40 participants will be asked to return to the clinic for additional sensory testing to help researchers learn if the tools used for this study are working as expected.

This additional testing is designed to help researchers learn how sensitive patient is to things such as touch, cold, warmth, and a pinprick to the finger, hand, or arm. Patient will be asked to describe how well they can feel each test, and how much pain they may or may not feel. This additional testing should take about 60 minutes to complete.

Length of Study:

After patient has completed the interview (if they are asked), 3 questionnaires, and 3 sensory tests their participation on this study will be over. If patient is selected to take part in the additional sensory testing, their participation on this study will be over after those tests are complete.

This is an investigational study.

Up to 200 participants will take part in this study. All will be enrolled at M. D. Anderson.

Chemotherapy-Induced Peripheral Neuropathy Survey

Chemotherapy-Induced Peripheral Neuropathy: Feasibility and Validity of New Symptom Measurement Tools in Patients on Treatment With Platinum Agents, Taxanes and Bortezomib

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease	NCT01656746	Adenomatous Pol... Crohn Disease Familial Adenom... Hereditary Inte... Recurrent Colon... Stage I Colon C... Stage IIA Colon... Stage IIB Colon... Stage IIC Colon... Stage IIIA Colo... Stage IIIB Colo... Stage IIIC Colo...	therapeutic lap...	18 Years - 80 Years	Ohio State University Comprehensive Cancer Center
Total Neoadjuvant Therapy in Rectal Cancer Treatment	NCT04747951	Rectal Cancer	Concurrent Chem... TME consolidation c... adjuvant chemot...	18 Years -	State Scientific Centre of Coloproctology, Russian Federation
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy	NCT00467922	Crohn's Disease Ulcerative Coli... Rectal Cancer Colon Cancer Colon Polyps Rectal Polyps Diverticulitis	Hextend Lactated Ringer...	18 Years - 80 Years	Spectrum Health Hospitals
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy	NCT00467922	Crohn's Disease Ulcerative Coli... Rectal Cancer Colon Cancer Colon Polyps Rectal Polyps Diverticulitis	Hextend Lactated Ringer...	18 Years - 80 Years	Spectrum Health Hospitals
Chemotherapy-Induced Peripheral Neuropathy Survey	NCT01016028	Breast Cancer Colorectal Canc... Myeloma Chemotherapy-in...	Questionnaire Sensory Tests Interview	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for colorectal disease