Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colonic Neoplasms

Diverticulum

Diverticular Diseases

Diverticulosis, Colonic

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Left laparoscopic laparoscopic colectomy patient managed on an outpatient basis

colectomy due to neoplastic (stage 1) or diverticulosis

Colectomy

Alexandre Smirnoff, MD

The success of the enhanced recovery program after surgery leads us to consider outpatient management of the colectomy. To this end, the investigators have designed an observational and prospective study of left laparoscopic colectomy on an outpatient basis. The objective is to assess the harmlessness of this management compared to standard management in the context of a public hospital.

In France, colectomy represents about 40,000 interventions per year, most of them scheduled, and 2/3 in a context of neoplasia. This surgery is associated with numerous postoperative complications. Since the start of Enhanced Recovery After Surgery (ERAS) in 1997, complications have been steadily reduced by optimizing surgical and anaesthetic techniques. At the same time, the average length of post-operative stay has decreased. In 2014, ERAS was the subject of recommendations by the French Society of Anaesthesia and Resuscitation, taken up by the French Health Authority (HAS) in 2016, and which are now an integral part of surgical management in colorectal surgery. More recently, two teams have set up an outpatient colectomy program. The three studies published on this subject show encouraging results, in a private structure, with no increase in postoperative complications.

In accordance with the recommendations on ERAS published by the HAS, a program involving pre-, per- and post-interventional investment, has been put in place. Patients are discharged on D0, followed by close monitoring by a home care nurse twice daily. This nurse is in charge of collecting clinical data in order to detect possible early signs of post-operative complications that would justify re-hospitalisation after a medical-surgical decision.

Outpatient Left Laparoscopic Colectomy

Outpatient Management of Patients With a Left Laparoscopic Colectomy

Number of re-hospitalisation after a medical-surgical decision due to post-operative complications

Time (in hours) between extubation and first mobilization

Number of day between surgery and first gas / stool

Medtronic

Groupe Hospitalier de la Rochelle Ré Aunis

Pain

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Transversus abdominis plane block utilizing the medication Exparel®

This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles

TAP Block

Epidural catheter placed prior to the operation in the standard fashion

Continuous Epidural Analgesia

Robert K Cleary, MD

The primary outcome for this study is the Numeric Pain Score (NPS) for elective patients undergoing elective colorectal surgery that have been randomized to transversus abdominis plane block or epidural anesthesia for the management of perioperative pain in elective colorectal surgery.

Adequate peri-operative analgesia is a vital component of post-operative management for patients undergoing colon and rectal surgery, affecting hospital length of stay, quality of life, and patient outcomes. There are many options for the peri-operative management of pain after elective colorectal surgery.

This is a randomized clinical trial comparing the transversus abdominis plane block using Exparel® to epidural anesthesia for the enhanced recovery pathway perioperative management of pain for elective colorectal surgery.

Trial Comparing Transversus Abdominis Plane Block Versus Epidural Anesthesia for Pain Management in Colorectal Surgery

A Prospective Randomized Clinical Trial Comparing the Transversus Abdominis Plane Block (TAP) Versus Epidural Anesthesia For Enhanced Recovery Pathway Perioperative Management of Pain in Elective Colorectal Surgery

Measured by patient using the numeric pain scale

Measured by patient completing the Overall Benefits of Analgesia Score survey

Saint Joseph Mercy Health System

Colon and Rectal Surgeon

Adjuvants, Anesthesia

Analgesics

Psychotropic Drugs

Fentanyl

Midazolam

Propofol

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Anti-Anxiety Agents

GABA Modulators

Neurotransmitter Agents

Analgesics, Opioid

Narcotics

Fentanyl and Midazolam sedation for colonoscopy discomfort

Propofol sedation for colonoscopy discomfort

Fentanyl will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 50µg of Fentanyl. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Fentanyl in no more than 50µg increments. increments.

Propofol will be administered IV according to standard procedure for colonoscopy. The initial bolus of propofol will be up to 60 mg IV. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more sedation in 10-20 mg boluses.

Midazolam will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 2 mg of Midazolam. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Midazolam in no more than 2 mg increments.

Robert Cleary, MD

The study aim is to determine if Propofol or the combination of Fentanyl and low-dose Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the participant, and the secondary outcome will be the discomfort of the patient and difficulty of the procedure as perceived by the physician.

Background The use of colonoscopy has become an important diagnostic and therapeutic tool in the evaluation of multiple medical conditions of the gastrointestinal tract. Despite its widespread use, there continues to be debate concerning the best pharmacologic approach to patient satisfaction and discomfort of the procedure and to minimize side effects.

Aim Two standard pharmacologic (Propofol or Fentanyl and low-dose Midazolam) approaches for colonoscopy will be evaluated systematically to determine if these two approaches are equivalent in terms of patient rating of satisfaction and patient discomfort to the procedure and side effects

Study Design This is a prospective randomized study of 262 participants undergoing outpatient colonoscopy at an independent academic medical center. The primary outcome of this study is participant's satisfaction, and the secondary outcome is discomfort of the patient as perceived by the physician performing the procedure.

Other Variables of Interest.

* Duration of procedure as defined by time the patient arrives in the room to the time the patient is appropriate for discharge.
* Difficulty of procedure rated by the physician on a scale of 0-10
* Colonoscopy completion rates (intubation of cecum).
* Complications including oxygen desaturation or hypotension.
* Cost of the two medication regiments

Compare Propofol to Fentanyl and Midazolam for Colonoscopy

Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.

Measured by the patient using a 100-point Visual Analog Scale (VAS) \[0-100%\] with higher score indicating higher agreement with the statement/question. Higher agreement scores would indicate higher satisfaction (better outcome).

Self-reported by patient via a Visual Analog Scale \[0-10\], where 0=no pain, 10=worst possible pain

Self-reported Physician/Endoscopist perceptions Measured via Visual Analog Scale \[0-10\] of: Highest pain, Average pain, Difficulty of procedure, Bowel preparation, Patient movement. A score of 0 on the scale=no pain/difficulty, while a score of 10=worst possible pain/difficulty/severity. The higher the score the worse the outcome.

Propofol: an initial dose of ≤60 mg intravenously, with additional dosing at the discretion of the anesthesia provider.

Propofol Intervention

Fentanyl: Fentanyl will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 50µg of Fentanyl. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Fentanyl in no more than 50µg increments. increments.

Midazolam: Midazolam will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 2 mg of Midazolam. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Midazolam in no more than 2 mg increments.

Midazolam/Fentanyl Intervention

Total

Age, Continuous

Sex: Female, Male

Body Mass Index is an index calculated by a person's weight in kilograms divided by the square of height in meters. In this case, the study used a categorical variable of BMI greater than or equal to 30 (yes, no)

BMI >=30

Congestive heart failure

History of myocardial infarction

Diabetes mellitus

Chronic obstructive pulmonary disease

Obstructive sleep apnea

History of diverticulitis

Ongoing malignancy

General health factors

Procedure time

Recovery time

Time in colonoscopy suite

Procedure/recovery times (min)

Midazolam, mg

Fentanyl, μg

Propofol, mg

The Row population represents the patients who received that drug which is specific to each Intervention Arm. The Propofol patient group would only receive Propofol (no Midazolam/Fentanyl received), and the M/F group would only receive Midazolam and Fentanyl (no propofol).

Amount of anesthetic drug used

Cecum intubation

This is a single-institution, single endoscopist study and is limited by the inability to perform blinding of the endoscopist.The endoscopist could not be blinded to treatment because of the presence of an anesthesia provider in the colonoscopy suite for the Propofol group. Anesthesia providers were not present for the midazolam/fentanyl group because we wanted to mimic and compare 2 of the most commonly used practice strategies as much as possible.

Robert K. Cleary, MD

To calculate the required sample size for this study, the equivalence limit was set at 5 units difference on the VAS, with an expected mean difference of 0. The common SD of 16.2 was estimated based on the range of expected scores for the VAS from Ulmer et al. Using these inputs, a total sample size of 262 patients was estimated to have 80% power to reject the null hypothesis that the test and standard were not equivalent and conclude that they were equivalent.

Recovery Room: Satisfaction with colonoscopy

Recovery Room: Would undergo another colonoscopy with same sedation

Recovery Room: Would encourage others to have same sedation

Recovery Room: Comfort

1-5 d postprocedure: Satisfaction with colonoscopy

1-5d postprocedure: Would undergo another colonoscopy with same sedation

1-5d postprocedure: Would encourage others to have same sedation

1-5d postprocedure: Comfort

All patients who completed the intervention were included in the analysis

Patient Satisfaction Scores (Absolute Value)

Recovery room: patient highest pain

Recovery room: Average pain

Recovery room: Average discomfort during recovery

1-5d postprocedure: Highest pain

1-5d postprocedure: Average pain

1-5d postprocedure: Average discomfort during recovery

All patients who completed the intervention were included

Patient Pain & Discomfort Rating (Absolute Value)

Endoscopist rating: Highest Pain

Endoscopist rating: Average Pain

Endoscopist rating: Difficulty of Procedure

Endoscopist rating: Bowel preparation

Endoscopist rating: Patient Movement

Physician Perceptions (Absolute Value)

Fentanyl and Midazolam sedation for colonoscopy discomfort

Fentanyl: Fentanyl will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 50µg of Fentanyl. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Fentanyl in no more than 50µg increments. increments.

Midazolam: Midazolam will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 2 mg of Midazolam. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Midazolam in no more than 2 mg increments.

Fentanyl and Midazolam

Propofol sedation for colonoscopy discomfort

Propofol: Propofol will be administered IV according to standard procedure for colonoscopy. The initial bolus of propofol will be up to 60 mg IV. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more sedation in 10-20 mg boluses.

Overall Study

Herbal and Botanical

Cola

Continuous Preperitoneal Analgesia for pain management

Continuous Epidural Analgesia for pain management

Preperitoneal catheter placed at the completion of surgery in the standard fashion.

Continuous Preperitoneal Analgesia

Epidural catheter placed prior to the operation in the standard fashion.

This is a prospective randomized study of 114 patients. The purpose of this study is to compare the efficacy of two standard methods of analgesia for pain control in patients undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS) and by the need for supplemental narcotic analgesics. This study is designed to determine if postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q Silver SoakerTM catheters (CPA) is equivalent to continuous epidural analgesia (CEA).

Background Perioperative analgesia is a vital part of the management of patients undergoing colon and rectal surgery, affecting well being and length of hospital stay. Neuraxial anesthetics infused through epidural or spinal catheters have become commonplace pain management agents for patients. These techniques, however, are labor-intensive and expensive. Alternatively, local analgesics may be administered directly to the surgical wound via silver catheters.

Aim Two standard methods of analgesia for pain control for colon and rectal surgery will be evaluated systematically to determine if these two approaches are equivalent in terms of patient pain scores and supplemental narcotic use.

Study Design This is a prospective randomized study of 114 participants undergoing elective colon and rectal surgery at an independent academic medical center. The primary outcomes are post-operative pain control and supplemental narcotic usage.

Other variables of interest

* Surgical site infections
* The post-operative time to return of bowel function
* The hospital expenses/cost differences
* Quality of life measured with the SF- 36 questionnaire

Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery

Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery

Measured by the patient using the numerical pain scale.

Measured by patient using the numerical pain scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Outpatient Left Laparoscopic Colectomy	NCT04310839	Colonic Neoplas... Colonic Diverti...	Colectomy	18 Years -	Groupe Hospitalier de la Rochelle Ré Aunis
Trial Comparing Transversus Abdominis Plane Block Versus Epidural Anesthesia for Pain Management in Colorectal Surgery	NCT02591407	Colon Cancer Rectal Cancer Colonic Diverti...	TAP Block Continuous Epid...	18 Years -	Saint Joseph Mercy Health System
Compare Propofol to Fentanyl and Midazolam for Colonoscopy	NCT01488045	Colon Cancer Rectal Cancer Colonic Diverti...	Fentanyl Propofol Midazolam	18 Years -	Saint Joseph Mercy Health System
Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery	NCT01552226	Colon Cancer Rectal Cancer Colonic Diverti...	Continuous Prep... Continuous Epid...	18 Years -	Saint Joseph Mercy Health System
Outpatient Left Laparoscopic Colectomy	NCT04310839	Colonic Neoplas... Colonic Diverti...	Colectomy	18 Years -	Groupe Hospitalier de la Rochelle Ré Aunis

Spots Global Cancer Trial Database for colonic diverticulosis