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Magnesium Oxide

Citric Acid

Sodium Citrate

Picosulfate sodium

Citrate

Patient is to administer one sodium bisphosphate (Fleet) enema at home 2 hours prior to arrival for surgery and a second enema one hour prior to arrival for surgery. Each 120 mL application of rectally administered enema contains 19g of monobasic sodium phosphate and 9 g of dibasic sodium phosphate. Patient is to follow standard packaging instructions from the manufacturer.

Patient is to take Pico Salax oral bowel preparation which is a combination product consisting of 10 mg picosulfate sodium, 3.5 g magnesium oxide, and 12 g citric acid per sachet the day prior to surgery. Patient is to take 2 doses of this product, as per standard packaging instructions from the manufacturer. Specifically patient is to take the first packet contents dissolved in 150 mL water at 3pm the day before surgery. Patient is to take the second packet dissolved in 150 mL water at 8pm the day before surgery. Patient should drink 2-3L of clear liquids after each dose, for a total of 4-6L.

standard pre-op application, see arm description

Fleet Enema

Pico-Salax

Katerina Neumann

There is no consensus about the best bowel preparation prior to transanal endoscopic surgery TES). Cleanliness and visibility in the rectosigmoid and rectum are of utmost importance, possibly even more so than during colonoscopy, to facilitate safe, precise and efficient resection of the rectal lesion and potentially adequate closure of the defect. Both Fleet enemas and oral mechanical bowel preparation are considered standard of care in preparation for TES. This single center two arm single blinded randomized controlled trial will compare the effectiveness of Fleet enemas in comparison to Pico Salax oral mechanical bowel preparation in cleansing the rectum as measured by a modified version of the Ottawa Bowel Prep Scale.

Oral mechanical bowel preparation with Pico Salax (picosulfate sodium, magnesium oxide, and citric acid) or alternative is considered a standard modality for cleansing the entire colon prior to colonoscopy or surgical procedures. Fleet enemas are sodium phosphate-based laxatives in the form of a liquid inserted rectally, which are also very effective at evacuating the solid stool from the sigmoid and rectum in preparation for procedures such as flexible sigmoidoscopy or anoscopy, which only require visualization of the distal colon and rectum. Commonly, endoscopists use the well validated bowel preparation scores such as the Boston Bowel Prep Score, Aronchick Scale or the Ottawa Bowel Prep Scale when evaluating the effectiveness of such bowel preparation regimens at clearing away all debris and opaque liquid from the colon. Few studies have been performed to evaluate whether an oral mechanical bowel preparation or a rectal application by means of fleet enemas or alternatives gives better visibility or is preferred by the patient. A randomized controlled trial comparing two fleet enemas with an oral preparation that consisted of magnesium citrate and two Dulcolax tablets for flexible sigmoidoscopy, were able to show that patient acceptance, encounter time, technical ease, quality of colon preparation was significantly better with the oral form of colon preparation than with standard fleet enemas. On the other hand, another randomized controlled trial were able to show that fleet enemas were superior to picosulfate based oral bowel preparation for flexible sigmoidoscopy while also showing a decreased incidence of associated adverse symptoms, and better patient tolerance. Conflicting studies exist. Both bowel regimens are considered standard of care in preparation for surgery of the sigmoid and rectum. Fleet enemas seem to be the preparation most commonly used for flexible sigmoidoscopy.

Transanal endoscopic surgery (TES) is a minimally invasive technique used to perform full thickness excisions of rectal lesions (benign and malignant) with precision, allowing access to lesions in the rectum as high as 22 cm from the anus. The technique can be performed using either the rigid transanal endoscopic microsurgery (TEM) platform or the flexible port termed transanal endoscopic minimally invasive surgery (TAMIS). The technique decreases risk of positive margins and local recurrence in comparison to standard local excision techniques in the operating room. It is the preferred method of local excision of rectal lesions. As with polyp detection and removal during flexible sigmoidoscopy, TES for rectal neoplasms requires excellent visibility and minimization of debris in order to be able to perform the precise excision of the lesion and help facilitate closure of the full thickness defect in the rectal wall. TES is performed globally with no consensus about the optimal bowel preparation regimen for achieving visibility and facilitating the easiest, most efficient and safest dissection.

Objectives:

The primary objective of this study is to determine whether oral Pico Salax bowel preparation regimen achieves a higher score on the Ottawa Bowel Prep Scale specifically for the rectosigmoid segment in comparison to 2 fleet enemas during TES.

The secondary objectives include validation of the Ottawa Bowel Prep Scale specifically for use with fleet enemas or Pico Salax for the rectosigmoid segment during TES; determining if there are differences in length of time spent cleaning the operative field by the surgeon; the ability to close the defect; post-operative short-term complications, and patient tolerability of the preparation.

This study will serve as a pilot study for a potentially larger multi-center pan Canadian RCT. The TEMPEST group is a collaboration of TES trained surgeons across Canada at tertiary care teaching hospitals, involved in research collaborations. The results of this study will be used to see if randomization to two different bowel regimens in this very select group of patients undergoing trans-anal surgery is feasible and can yield informative data. The study will be powered for the primary objective, but we will be collecting data on numerous secondary objectives which may show important trends. If the study proves to be feasible, the next step would be to expand the study to several other centers across Canada as part of the TEMPEST collaborative, in order to collect much larger datasets and the power to look much more closely at not only the primary objective but also the secondary objectives.

A single center, 2-arm, single blinded randomized controlled trial

The participant will receive information pertaining to which arm of the trial they have been randomized to by the research coordinator. The surgeons, residents, any other physicians involved in the care of the patient, and nursing staff will all be blinded to the treatment arm.

TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

Transanal Endoscopic Surgery: a Randomized Controlled Trial Comparing Fleet Enema vs Oral Mechanical Bowel Prep (TESEO Trial)

Measurement of the quality of cleanse of the rectum, expressed as a score on a modified version of the Ottawa Bowel Prep Scale (OBPS).

The OBPS will be used to assess the one segment of the bowel visualized during TES surgery (rectosigmoid) using the segmental scale 0-4, where 0 is the best score and 4 is inadequate.

validation of the modified version of the OBPS as it applies to the use of Fleet enema and Pico Salax oral bowel prep in the rectosigmoid segment specifically for use in preparation for TES

A measure of the time spent cleansing the operating field by the surgeon as per review of recording of the surgery

An assessment as to whether the surgical wound in the rectum was left open or sutured closed

An assessment of the patients tolerability of the prep, symptoms associated with the prep, whether they were able to complete the prep, satisfaction and willingness to take the same prep in the future, performed using a questionnaire. In the questionnaire, the severity of the symptoms associated with the prep can be selected from mild, moderate, severe, and intolerable.

An assessment of in-hospital as well as short term complications assessed at time of discharge and during 6-week post-operative visit

Nova Scotia Health Authority

Assistant Professor, colorectal surgeon

Adenocarcinoma

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transanal endoscopic microsurgery (TEM), 3-D vision system using a rectoscope, which allows access to rectal tumors located up to 20 cm from the anal verge

Transanal endoscopic operation (TEO). Through its 2-D vision system using a rectoscope, this procedure allows access to rectal tumors located up to 20 cm from the anal verge

2-D high definition vision systems, transanal endoscopic operation (TEO)

Transanal endoscopic microsurgery (TEM). 3-D vision system using a rectoscope, allowing access to rectal tumors located up to 20 cm from the anal verge

Transanal endoscopic microsurgery (TEM)

Xavier Serra-Aracil, MD

Introduction: The usual surgical technique for large adenomatous tumors and rectal cancer is anterior resection of the rectum or abdominoperineal resection. These techniques are associated with high mortality and morbidity and with genitourinary dysfunctions.

To solve these problems, transanal endoscopic microsurgery (TEM) was designed. Through its 3-D vision system using a rectoscope, this procedure allows access to rectal tumors located up to 20 cm from the anal verge. It is associated with minimal morbidity and has few repercussions for anal continence.

The use of 2-D high definition cameras and screens obtains images of a similar quality to 3-D images. This means that from the surgical point of view the procedure known as TEO (transanal endoscopic operation) seems as practicable as classic TEM.

Main aim: To assess the effectiveness of 2-D high definition vision systems (TEO) versus conventional 3-D (TEM) in endoscopic surgery of rectal tumors, with respect to surgical facility, postoperative morbidity, quality of the surgical specimens, and cost.

Design: Prospective, controlled, randomized study of the efficacy of the use of 2-D high definition endoscopic systems versus 3-D (TEM) in transanal endoscopic surgery.

Disease studied: Rectal adenomas and adenocarcinomas "in situ" suitable for local surgery.

Main variable evaluated: Cost per procedure assuming similar surgical efficacy and equal postoperative morbidity.

Study population and total number of patients: Patients diagnosed with rectal tumor treated with curative intent (rectal adenomas and adenocarcinomas "in situ"). The total sample calculated for the trial was 36 patients, 18 in each group (TEO and TEM).

Timing and expected finish date: After approval by the CEIC, the expected date for the inclusion of the first patient was August 2010. The study is expected to last 18-24 months.

Efficiency of Two Dimensional High Definition vs Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery

Comparing the Efficiency of Two Dimensional High Definition (TEO) Versus Three Dimensional (TEM) Endoscopic Systems in Transanal Endoscopic Surgery; a Prospective Control Trial

Corporacion Parc Tauli

Medical Doctor

Symptoms and General Pathology

Neoplastic Cells, Circulating

Neoplasm Metastasis

Neoplastic Processes

Laparoscopic total mesorectal excision was performed on the enrolled patients.

Transanal total mesorectal excision was performed on the enrolled patients.

Different surgical methods for rectal cancer resection

Surgical approach

Liang Huang

The primary purpose of this study is to compare the changes of circulating tumor cells (CTCs) at different time points in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection. Our secondary purpose is to explore the effects of perioperative circulating tumor cells on tumor recurrence and metastasis.

Mid-low rectal cancer is one of the common malignant tumors and the incidence has increased significantly in recent years. At present, surgery is still the most important and effective method for the treatment of mid-low rectal cancer. Traditional laparoscopic surgery and emerging transanal total mesorectal excision (TaTME) are the main methods. More than one-third of rectal cancer patients will eventually occur local recurrence and distant metastasis, which are the most important factors affecting prognosis. Circulating tumor cells may lead to distant metastasis, so the detection of CTCs in blood has important clinical significance in predicting the recurrence and metastasis of rectal cancer and monitoring treatment response. Due to the different degrees of contact between distinct surgical methods, this may lead to an increase in the quantity of CTCs in the blood, which may affect the prognosis of patients. Therefore, the investigators conducted a randomized controlled study to compare the changes in the quantity of CTCs in the central vein before, during and after operation in rectal cancer patients undergoing transanal endoscopic or laparoscopic radical resection. To explore the effect of two surgical methods on the risk of micrometastasis, and to provide evidence for the selection and improvement of rectal cancer treatment.

Change of Circulating Tumor Cells During Laparoscopic or Transanal Endoscopic Surgery for Rectal Cancer.

Sixth Affiliated Hospital, Sun Yat-sen University

To determine the changes of circulating tumor cells in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection before operation and 5 days after operation.

Determine relationship of CTC numbers and local recurrence and distant metastasis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TES RCT Fleet Enema vs Oral Mechanical Bowel Prep	NCT05148494	Colorectal Neop... Surgery	Fleet Enema Pico-Salax	18 Years - 75 Years	Nova Scotia Health Authority
Efficiency of Two Dimensional High Definition vs Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery	NCT01498354	Rectal Adenoma	2-D high defini... Transanal endos...	18 Years - 90 Years	Corporacion Parc Tauli
Change of Circulating Tumor Cells During Laparoscopic or Transanal Endoscopic Surgery for Rectal Cancer.	NCT05109130	Rectal Neoplasm... Neoplastic Cell... Laparoscopic Su... Transanal Endos...	Surgical approa...	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for transanal endoscopic surgery