Neoplasms

Digestive System Diseases

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Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

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Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Right, left colon surgery, transverse colon surgery, multiple colon surgery in open and minimally invasive surgert

Colon Surgery

Bruno Nardo, MD,PhD

CR-POSSUM is one of the most used surgical scores to predict mortality after colorectal surgery. Its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. The primary aim of the study is to develop a new surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population. The secondary objective is to analyze its efficacy compared to CR-POSSUM.

Patients aged 80 and older undergoing surgery for colon cancer from 2011 to 2017 in an Italian hospital were retrospectively selected. MECC score \[Mortality in Elderly patients with Colon Cancer\] was calculated summing up the scores relating to: arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine. Once CR-POSSUM was calculated, the two scores were compared.

Mortality Score in Elderly Patients With Colon Cancer

Score for the Prediction of Mortality Risk After Surgery for Colon Cancer in a Case Series of Elderly Patients

MEC Score (arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine) for the evaluation of the risk of in-hospital mortality occurred during hospitalization up to 30 days

University of Bologna

Adjunct Professor MD, PhD

Symptoms and General Pathology

Nervous System Diseases

Pain, Postoperative

Nausea

Vomiting

Postoperative Nausea and Vomiting

Pain

Ileus

Signs and Symptoms, Digestive

Postoperative Complications

Neurologic Manifestations

Intestinal Obstruction

Acupuncture is the insertion of needles at certain body points.

Acupuncture will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge.

Acupuncture

Sham Acupuncture involves the acupuncturist tapping a plastic guiding tube on the surface of the true points to produce some discernible sensation and then immediately tapping a real needle sideways parallel to the skin surface without needle insertion. It will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge,

Sham Acupuncture

Gary Deng, MD, PhD

The purpose of this study is to see whether acupuncture may help patients recover from colon cancer surgery.

* To determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by evidence of reduction of postoperative ileus when compared to sham acupuncture.
* To explore whether acupuncture reduces the length of hospital stay more than sham acupuncture
* To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting.
* To determine the feasibility of a Phase III trial in terms of sample size, accrual rate, attrition rate and data completion.

Postoperative ileus contributes to prolonged hospital stay, readmission and postoperative morbidities in patients undergoing major abdominal surgery. Reduction of postoperative ileus is important in postoperative recovery. Postoperative pain may require opioids, which further reduce gastrointestinal (GI) motility. Postoperative nausea and vomiting hamper the resumption of oral intake. Together, these three common postoperative problems contribute to patient discomfort, delayed discharge and increased overall hospitalization costs, despite current multi-modal management options. Any safe and effective therapy in addition to current standard of care would be welcomed by patients, surgeons and hospitals.

Acupuncture is a complementary medicine modality shown to reduce postoperative pain, suppress nausea and vomiting, and promote GI motility. It is associated with few adverse events. Here we propose a randomized, sham controlled phase II study to evaluate acupuncture, in addition to conventional therapy, for its safety and effectiveness in improving postoperative recovery of colorectal cancer patients undergoing segmental or subtotal colectomy. The overall objective of this developmental project is to determine whether a more extended research project is warranted.

The specific aims are:

* To determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by evidence for a reduction of postoperative ileus when compared to sham acupuncture. Hypothesis: acupuncture promotes upper and lower GI motility in patients experiencing postoperative ileus after colectomy more than sham acupuncture.
* To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting. Hypothesis 2a: acupuncture reduces postoperative pain more than placebo in colectomy patients; 2b: acupuncture reduces postoperative nausea and vomiting more than placebo in colectomy patients.
* To determine the feasibility of a phase III trial in terms of sample size, accrual rate, attrition rate and data completion. Hypothesis 3: a phase III study of acupuncture in the treatment of post-colectomy ileus in cancer patients is feasible.

Trial of Acupuncture for Reduction of Post-Colectomy Ileus

A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus

National Institutes of Health (NIH)

Memorial Sloan Kettering Cancer Center

Gastrointestinal Agents

Pancrelipase

Pancreatin

Participants will be robotic surgeons in urologic, gynecologic, colorectal, hepatobiliary, gastric, and thoracic surgery

Surgeons will perform and participants will undergo robotic surgery according to the standard of care. No additional interventions will be performed on participating participants.

Robotic Surgery

Alvin Goh, MD

The purpose of this study is to develop new tools to understand surgeon performance to improve surgical training and participant outcomes after surgery.

Improving Surgeon Performance Measures for Robot-Assisted Surgery

Generalized Robotic Skills Assessment Using Machine Learning-Based Analysis Across Multiple Surgical Specialties

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

For the primary objective, we will capture Automated Performance Metrics/APMs and will determine the association between these and other metrics and surgeon experience, which will be used to construct validation.

APMs that will be used in the study:

Time Metrics

Camera Metrics

Instrument Metrics

System Metrics

Articulation Metrics

Rectal Diseases

Dilek Yazicioglu, specialist

Mustafa Ozmen, assistant

Mustafa Ozmen, MD

Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also investigated.

Patient records from patients underwent colorectal surgery between 2010-2011 will be studied. It was planned to include patients undergoing laparoscopic colorectal surgery with a predetermined anaesthesia protocol.

Patients will receive a standardized general anesthetic and thoracal epidural anaesthesia. Ventilatory parameters will be adjusted to maintain ETCO2 35 mmHg, Paw 25 cmH2O.Patient age, gen-der, BMI, ASA classification, the duration of surgery, anesthesia, Trendelenburg position and pneumoperitoneum. Hemodynamic parameters, blood gas analyzes, ventilation parameters and EtCO₂ values will be recorded. We determined 6 timelines to compare the difference between PaCO₂ and EtCO₂. These timelines were the times where we could collect the most data regarding blood gas analyzes. Preoperative period: to, 10th minute after the first insuflation and trendelendburg position: t₁,the first hour after the first insuflation and trendelendburg position: t₂, 10th minute after desuflation and supine position: t₃, 10th minute after the second insuflation and trendelendburg position: t₄, and 10th minute after the second desuflation and supine position:t₅. Primary outcome measure is the difference between PaCO₂ and EtCO₂ a difference greater than 5 mmHg was assumed to be important.

The Investigation of the EtCO₂- PaCO₂ Relation During Laparoscopic Colon Surgery

Cohort Study on Patients Underwent Colorectal Surgery

Diskapi Teaching and Research Hospital

principal İnvestigator

Nutritional and Metabolic Diseases

Malnutrition

Nutrition Disorders

Stefan F Mühlebach, Prof

The prevalence of malnutrition in patients with colorectal cancer is recorded. We want to find out, if a malnourished patient has more complications after the elective surgery.

All patients attending elective colorectal surgery are screened for malnutrition in advance. Their length of stay in the hospital and the complications are recorded.

Effects of Malnutrition on Colon Cancer Patients With Abdominal Surgery

Insel Gruppe AG, University Hospital Bern

Dr. med. Zeno Sanga

Gabriel Liberale, MD

Evaluation of the possibility to detect sentinel lymph node(s) after ex vivo Indocyanine Green injections around the tumour in pieces of colectomy from patients with colon cancer.

Primary objective Feasibility study of ex vivo injections of ICG to image and detect the sentinel lymph nodes in patients with colon cancer.

Secondary objectives:

To determine the sensitivity of ICG in the dissected piece of colon cancer compared with the blue dye.

Tertiary objectives:

Evaluation of the influence of this approach on the up-staging of the patients

Microscopic study of the ICG distribution in the lymph nodes (in the lymphatic sinuses, in specific cells, in cancerous foci...)

Methodology:

In the operating room:

Patients will undergo standard surgical resection. Immediately after removal of the colon and node-bearing mesentery, using different 29 Gauge insulin syringes, blue dye (2 ml blue dye: 0.5 ml per injection) and ICG (2 ml with 0,5 mg ICG per ml: 0.5 ml per injection) will be injected in the fresh specimen beside each other submucosally around the tumour in at least four sites (as many injections needed to cover all the perimeter of the tumour) for each agent. The injection sites will be then gently stretched and massaged for 3-5 min to stimulate the tracers to flow along the lymphatic channels. Fluoroscopic imagings of the mesentery will be performed during the injections and during these manoeuvers.

The research and identification of the sentinel lymph nodes will be then performed as follows:

1. he will first localize the blue colored lymph vessels (if visible) as well as the palpable and/or blue colored lymph nodes. These last ones will be marked for dissection with a blue suture.
2. using the PDE camera, he will thereafter localize the fluorescent lymph vessels (if visible) as well as the palpable and/or fluorescent lymph nodes. These last ones will be marked for dissection with a green suture.

Histopathology in the Laboratory of Pathology:

When all SLN are identified, they will be dissected and classified as follows:

* SLN first seen as blue and confirmed also as fluorescent using PDE
* SLN seen as blue but not confirmed to be fluorescent using PDE
* SLN not directly visible as blue but seen fluorescent using PDE (the LN in this group will be controlled for their blue or not character when dissected)
* LN identified by the pathologist as pathological but not blue and not fluorescent.

After the dissection of these SLN, the specimen will be processed as usual using routine procedure for further examination of the non SLN by the pathologists. Once these lymph nodes are dissected, they will be tested for the emitted fluorescence.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mortality Score in Elderly Patients With Colon Cancer	NCT04538404	Mortality Surgery Colon Cancer	Colon Surgery	80 Years -	University of Bologna
Trial of Acupuncture for Reduction of Post-Colectomy Ileus	NCT00402961	Postoperative I... Colon Cancer Pain, Postopera... Postoperative N...	Acupuncture Sham Acupunctur...	18 Years -	Memorial Sloan Kettering Cancer Center
Mortality Score in Elderly Patients With Colon Cancer	NCT04538404	Mortality Surgery Colon Cancer	Colon Surgery	80 Years -	University of Bologna
Improving Surgeon Performance Measures for Robot-Assisted Surgery	NCT06037837	Surgery	Robotic Surgery	18 Years -	Memorial Sloan Kettering Cancer Center
The Investigation of the EtCO₂- PaCO₂ Relation During Laparoscopic Colon Surgery	NCT01707511	Colorectal Canc...		-	Diskapi Teaching and Research Hospital
Mortality Score in Elderly Patients With Colon Cancer	NCT04538404	Mortality Surgery Colon Cancer	Colon Surgery	80 Years -	University of Bologna
Effects of Malnutrition on Colon Cancer Patients With Abdominal Surgery	NCT00622999	Malnutrition Colon Cancer		18 Years -	Insel Gruppe AG, University Hospital Bern
Effects of Malnutrition on Colon Cancer Patients With Abdominal Surgery	NCT00622999	Malnutrition Colon Cancer		18 Years -	Insel Gruppe AG, University Hospital Bern
Indocyanine Green (ICG) in the ex Vivo Detection of Sentinel Lymph Node (SLN)in Colon Cancer	NCT01995591	Colon Cancer Colon Surgery		18 Years -	Jules Bordet Institute
Mortality Score in Elderly Patients With Colon Cancer	NCT04538404	Mortality Surgery Colon Cancer	Colon Surgery	80 Years -	University of Bologna

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