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

Colonic Neoplasms

Herbal and Botanical

All Drugs and Chemicals

Cola

Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum.

Robotic-assisted resection of the colon or rectum in subjects with benign or malignant colon or rectal disease, where SureForm™ Staplers are utilized for transection and/or creation of anastomosis.

Colorectal resection

The primary objective of this study is to evaluate the performance of SureForm™ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.

This is a prospective, single-center observational study to evaluate the performance of SureForm™ Staplers during robotic-assisted resections of either ascending or transverse or descending or sigmoid colon or rectum. Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum will be asked to provide informed consent for their participation in the study.

The study will be conducted at one institution with two surgeons performing the colorectal procedures. The surgeons will be using either the da Vinci Xi or X Surgical System which ever they use as per their standard of care for the colorectal procedure. Stapling will be performed with SureForm™ Staplers and any of the reloads as per the surgeon's standard of care for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.

A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures

The primary endpoint of the study is to assess the number of fires and reload colors of SureForm™ Staplers utilized for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.

The secondary endpoint of the study is to assess the incidence of peri-operative and short term outcomes following transection and/or creation of anastomosis using SureForm™ Staplers during robotic-assisted colorectal procedures.

Intuitive Surgical

Anus Diseases

Patients receive dietary fiber PO QD for 28 days. Patients may undergo standard of care proctoscopy or anoscopy with biopsy on study and at follow up or may undergo standard of care colonoscopy on study. All patients also undergo collection of blood samples on study and at follow up.

Dietary Fiber

Proctoscopy or anoscopy with Biopsy

Colonoscopy

Questionnaire Administration

Shahrose Rahman, M.D.

Amber O'Connor

Vassiliki L. Tsikitis, M.D.

Vassiliki L Tsikitis, M.D.

This clinical trial tests whether daily fiber supplementation will change the mucosal microbiome of the colon. The microbiome are microorganisms that live in the human gut. They serve a vital role in maintaining health. Certain microbial strains are associated with the growth of colon polyps, which eventually could go on to form colon cancer. Giving dietary fiber supplements may help prevent precancerous polyps from ever developing.

PRIMARY OBJECTIVE:

I. To identify how diet, specifically fiber supplementation, alters the microbiome of the colonic mucosa.

OUTLINE:

Patients receive dietary fiber orally (PO) once daily (QD) for 28 days. Patients may undergo standard of care proctoscopy or anoscopy with biopsy on study and at follow-up or may undergo standard of care colonoscopy on study. All patients also undergo collection of blood samples on study and at follow up.

Impact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome

Changes in Colonic Microbiome With Fiber Supplementation

Will use data visualization techniques to understand the data and determine if microbiome count overall (richness) changes occur in patients who are started on fiber supplementation. In order to visualize overall changes after fiber supplementation, will generate plots showing relative abundance of the detected taxa for each subject at baseline and post-supplementation. For each taxa, will generate box plots to visually compare the median and interquartile range (IQR) of abundance between the two time points. Wilcoxon signed rank tests with an alpha level of 0.05 will determine if there is a difference in microbial derived short chain fatty acids after fiber supplementation in the blood and mucosa.

Will use data visualization techniques to understand the data and determine if the types of metabolites (microbiome diversity) cases occur in patients who are started on fiber supplementation. In order to visualize overall changes after fiber supplementation. To assess for changes in microbiome diversity, our primary analysis will compare median Shannon diversity index values at baseline and post-supplementation. The Shannon index estimates diversity using richness and abundance. Will calculate Shannon index values for each participant at each time point and use a Wilcoxon signed rank test with an alpha level of 0.05 to determine if there is a difference in microbiome diversity after fiber supplementation.

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
A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures	NCT04247958	Benign Colon Tu... Malignant Color... Benign Colorect...	Colorectal rese...	18 Years -	Intuitive Surgical
Impact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome	NCT05643859	Benign Colorect... Non-Neoplastic ...	Dietary Fiber Proctoscopy or ... Colonoscopy Questionnaire A...	18 Years -	OHSU Knight Cancer Institute
A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures	NCT04247958	Benign Colon Tu... Malignant Color... Benign Colorect...	Colorectal rese...	18 Years -	Intuitive Surgical

Spots Global Cancer Trial Database for benign colorectal neoplasm