Neoplasms

Digestive System Diseases

All Conditions

Wounds and Injuries

Symptoms and General Pathology

Colorectal Neoplasms

Inflammatory Bowel Diseases

Intestinal Diseases

Diverticulum

Diverticular Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Rectal Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Surgery carried out through a single incision laparoscopic approach

Single-port access surgery

Surgery through standard multiport laparoscopic approach

Conventional Laparoscopic Access

David W Borowski, MD FRCSEd

Talvinder S Gill, MS FRCS

Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal resections, due to it's short-term benefits over conventional open surgery. In recent years, several studies have demonstrated that - in suitable patients - single-port access surgery (SPA) has similar clinical outcome compared to CL, with additional cosmetic benefits. It remains, however, unclear whether the trauma of surgery is also less for SPA compared to CL.

In this study, the investigators aim to randomise patients who are deemed suitable for SPA surgery to either SPA approach, or CL; in addition to clinical outcomes including length of operating time, post-operative pain scores, complications, quality of life indicators and cosmetic appearance, the investigators aim to compare the physiological response to trauma through biochemical markers (including C-reactive protein, White Blood Cell count) and cytokine expression (i.e. Interleukins IL-6 and IL-8). Patients will be analysed according to intention-to-treat analysis, with 25 patients in the SPA and 25 patients in the CL group. The patients will be operated by surgeons proficient in both CL and SPA surgery, and followed-up for the duration of their hospitalisation as well as at their routine out-patient visits, using questionnaires.

Single-port Versus Conventional Laparoscopic Colorectal Surgery

Randomised-controlled Trial on the Immune Response to Single-port Access Versus Conventional Laparoscopic Colorectal Surgery

Complication / Conversion-to-open-surgery rates

Assessment of overall cost, including theatre time, disposable equipment and length of hospital stay

Immune response to tissue trauma (Interleukin-6)

North Tees and Hartlepool NHS Foundation Trust

Consultant General and Colorectal Surgeon

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Pain

The control arm will receive no intervention and will follow standard of care for post-operative pain management.

The PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing.

Post-operative pain management as indicated by pharmacogenomic testing results.

PGx-guided post-operative pain management

David Liska, MD

The primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major abdominal surgery.

Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

Post-operative opioid use through visual analog scale guided administration of narcotic equivalent

Assessed through Duke Activity Status Index (DASI)

The Cleveland Clinic

Associate Staff, Colorectal Surgery

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients in this limb receive epidural analgesia

epidural

Patients in this limb receive a PCA for their pain control

Patients in limb will receive spinal analgesia

Spinal

Bruce F Levy, MRCS

Tim Rockall, FRCS

The aim is to ascertain which method out of epidural, spinal or patient controlled analgesia (PCA) is the most appropriate in fluid optimised patients after laparoscopic colorectal surgery in terms of pain control, length of hospital stay and time for gut recovery. The second aim is to assess the physiological changes that occur when the patient is placed in steep trendelenberg position together with the creation of the pneumoperitoneum.

Patients will be randomized into one of 3 groups - A, B or C. In order to remove the major confounding factor of hypovolaemia, all patients will have an oesophageal doppler inserted in order to achieve fluid optimisation. Each group will then either have an epidural, spinal or a PCA for post operative analgesia depending on the randomisation. All patients will follow a common postoperative care pathway to standardize the other factors.

Patients will be asked to report parameters including pain visual analogue score (VAS) chart three times a day. Recovery of bowel functions (passage of flatus, bowel movement, and diet intake), additional analgesia consumption, time to first ambulation, analgesia related side-effects and time to discharge will be recorded.

In addition whilst the patients fluid status is optimized during surgery with the oesophageal Doppler, the physiological changes that occur with the steep trendelenberg position and the pneumoperitoneum will be recorded.

Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery

Randomised Controlled Trial Comparing the Effects of Epidural, Spinal and PCA in Patients Undergoing Laparoscopic Colectomy.

Minimal Access Therapy Training Unit

Bruce Levy

Carcinoma

Adenoma

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients receiving routine colonoscopy (for a multitude of indications) at the study centers are eligible for participation

Peter Klare, MD

Peter Born, Prof. Dr.

Stefan von Delius, MD

Benign adenomas of the colon have the potential to degenerate and become malignant. Therefore adenomatous polyps should be detected and resected during colonoscopy. Factors like advanced age and male gender are associated with the detection of adenomas. The same epidemiological pattern can be found with regard to colon diverticula. Furthermore, western world countries report higher incidences of both colorectal carcinoma as well as diverticular disease. It is not known whether a correlation exists between both entities. Some recent data have postulated higher adenoma detection rates in patients with concomitant diverticular disease (Rondagh EJ et al. Eur J Gastroenterol Hepatol. 2011; 23:1050-5. Kieff BJ et al. Am J Gastroenterol 2004; 99: 2007-11). If a positive correlation could be found this would possibly affect recommendations regarding colonoscopy surveillance intervals for patients with and without diverticular disease. The investigators therefore plan to conduct the following trial.

Impact of Diverticular Disease on the Detection of Colon Adenomas

After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined

a maximum of one day is expected for colonoscopy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single-port Versus Conventional Laparoscopic Colorectal Surgery	NCT01626963	Colorectal Canc... Inflammatory Bo... Benign Colorect... Diverticular Di...	Single-port acc... Conventional La...	18 Years -	North Tees and Hartlepool NHS Foundation Trust
Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery	NCT03455751	Colorectal Canc... Diverticular Di... Crohn Disease Ulcerative Coli...	PGx-guided post...	18 Years - 80 Years	The Cleveland Clinic
Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery	NCT00747292	Neoplasm Diverticular Di... Analgesia	epidural PCA Spinal	18 Years -	Minimal Access Therapy Training Unit
Impact of Diverticular Disease on the Detection of Colon Adenomas	NCT02057562	Colon Adenoma Diverticulosis		18 Years - 90 Years	Technical University of Munich

Spots Global Cancer Trial Database for diverticular disease