Colorectal NeoplasmsPhase 4TESEONCT05148494
TES RCT Fleet Enema vs Oral Mechanical Bowel Prep
A Phase 4 study testing Fleet Enema and Pico-Salax in people with Colorectal Neoplasms and Surgery, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Surgery
- What is being tested?
- Fleet Enema and Pico-Salax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 16 Mar 2022to 1 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons
Who cannot join
- chronic constipation not well controlled with diet or stool softening agents
- previous pelvic radiation
- inflammatory bowel disease
- repeat transanal surgery for the same lesion
- patient unable to self-administer enemas
- patient unable to tolerate either of the 2 bowel preps due to medical reasons
Show all 11Show fewer
- age over 75
- clear diagnosis of congestive heart failure
- daily use of Lasix or similar loop diuretic
- chronic steroid use
- Transanal Endoscopic Surgery combined with another surgical procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Victoria General Hospital
Halifax, Nova Scotia, B3H 2Y9
Katerina Neumann, 9024733937, katerina.neumann@nshealth.ca
About this study
Official title: Transanal Endoscopic Surgery: a Randomized Controlled Trial Comparing Fleet Enema vs Oral Mechanical Bowel Prep (TESEO Trial)
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.
Read the detailed description
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.
- Conditions
- Colorectal Neoplasms, Surgery
- Being tested
- Fleet Enema, Pico-Salax
- Keywords
- transanal endoscopic surgery, TEM, TAMIS, rectal neoplasm, oral mechanical bowel preparation, fleet enema, Ottawa bowel prep score
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fleet EnemaDrug
standard pre-op application, see arm description
Pico-SalaxDrug
standard pre-op application, see arm description
| Study group | Role | What they receive |
|---|---|---|
| Fleet Enema | Active comparator | 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. Receives: Drug: Fleet Enema |
| Pico Salax | Active comparator | 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. Receives: Drug: Pico-Salax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation
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.
Measured: A one-time intra-operative assessment for each patient
Secondary outcomes (5)
Validation of the modified version of the Ottawa Bowel Prep Scale
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
Measured: A one-time intra-operative assessment for each patient by a second blinded surgeon
Time spent cleaning operating field
A measure of the time spent cleansing the operating field by the surgeon as per review of recording of the surgery
Measured: A one-time intra-operative assessment for each patient
Ability to close the surgical defect
An assessment as to whether the surgical wound in the rectum was left open or sutured closed
Measured: A one-time intra-operative assessment for each patient
Patient tolerability of preparation
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.
Measured: A one-time pre-op assessment for each patient the morning of surgery
Post-operative complications
An assessment of in-hospital as well as short term complications assessed at time of discharge and during 6-week post-operative visit
Measured: At discharge and at 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start16 Mar 2022
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single center, 2-arm, single blinded randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katerina Neumann, Nova Scotia Health Authority
- Investigators
- Katerina Neumann, Principal investigator, NSHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148494
- Sponsor's protocol ID
- Protocol v2
- Acronym
- TESEO
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2021
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Parekh PJ, Oldfield EC 4th, Johnson DA. Bowel preparation for colonoscopy: what is best and necessary for quality? Curr Opin Gastroenterol. 2019 Jan;35(1):51-57. doi: 10.1097/MOG.0000000000000494.
PubMed 30489414Parra-Blanco A, Ruiz A, Alvarez-Lobos M, Amoros A, Gana JC, Ibanez P, Ono A, Fujii T. Achieving the best bowel preparation for colonoscopy. World J Gastroenterol. 2014 Dec 21;20(47):17709-26. doi: 10.3748/wjg.v20.i47.17709.
PubMed 25548470Atkin WS, Hart A, Edwards R, Cook CF, Wardle J, McIntyre P, Aubrey R, Baron C, Sutton S, Cuzick J, Senapati A, Northover JM. Single blind, randomised trial of efficacy and acceptability of oral picolax versus self administered phosphate enema in bowel preparation for flexible sigmoidoscopy screening. BMJ. 2000 Jun 3;320(7248):1504-8; discussion 1509. doi: 10.1136/bmj.320.7248.1504.
PubMed 10834891Ruangsin S, Chowchuvech V. A randomized double-blind controlled trial comparing two forms of enema for flexible sigmoidoscopy. J Med Assoc Thai. 2007 Nov;90(11):2296-300.
PubMed 18181310Preston KL, Peluso FE, Goldner F. Optimal bowel preparation for flexible sigmoidoscopy--are two enemas better than one? Gastrointest Endosc. 1994 Jul-Aug;40(4):474-6. doi: 10.1016/s0016-5107(94)70213-6.
PubMed 7926539Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
PubMed 19136102Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.
PubMed 20883845Aronchick C, Lipschultz W, Wright S. Validation of an instrument to assess colon cleansing. Am J Gastroenterol 1993;94:2667.
Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004 Apr;59(4):482-6. doi: 10.1016/s0016-5107(03)02875-x.
PubMed 15044882Kao D, Lalor E, Sandha G, Fedorak RN, van der Knoop B, Doornweerd S, van Kooten H, Schreuders E, Midodzi W, Veldhuyzen van Zanten S. A randomized controlled trial of four precolonoscopy bowel cleansing regimens. Can J Gastroenterol. 2011 Dec;25(12):657-62. doi: 10.1155/2011/486084.
PubMed 22175055Holt EW, Yimam KK, Ma H, Shaw RE, Sundberg RA, Verhille MS. Patient tolerability of bowel preparation is associated with polyp detection rate during colonoscopy. J Gastrointestin Liver Dis. 2014 Jun;23(2):135-40. doi: 10.15403/jgld.2014.1121.232.ewh1.
PubMed 24949604Kim MJ, Hong CW, Kim BC, Park SC, Han KS, Joo J, Oh JH, Sohn DK. Phase II Randomized Controlled Trial of Combined Oral laxatives Medication for BOwel PREParation (COMBO-PREP study). Medicine (Baltimore). 2016 Feb;95(7):e2824. doi: 10.1097/MD.0000000000002824.
PubMed 26886637Sharma VK, Chockalingham S, Clark V, Kapur A, Steinberg EN, Heinzelmann EJ, Vasudeva R, Howden CW. Randomized, controlled comparison of two forms of preparation for screening flexible sigmoidoscopy. Am J Gastroenterol. 1997 May;92(5):809-11.
PubMed 9149190Drew PJ, Hughes M, Hodson R, Farouk R, Lee PW, Wedgwood KR, Monson JR, Duthie GS. The optimum bowel preparation for flexible sigmoidoscopy. Eur J Surg Oncol. 1997 Aug;23(4):315-6. doi: 10.1016/s0748-7983(97)90723-x.
PubMed 9315059Bini EJ, Unger JS, Rieber JM, Rosenberg J, Trujillo K, Weinshel EH. Prospective, randomized, single-blind comparison of two preparations for screening flexible sigmoidoscopy. Gastrointest Endosc. 2000 Aug;52(2):218-22. doi: 10.1067/mge.2000.107907.
PubMed 10922094
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transanal Endoscopic Surgery: a Randomized Controlled Trial Comparing Fleet Enema vs Oral Mechanical Bowel Prep (TESEO Trial)
- ClinicalTrials.gov ID
- NCT05148494
- Acronym / sponsor ID
- TESEO / Protocol v2
- Conditions
- Colorectal Neoplasms, Surgery
- Keywords
- transanal endoscopic surgery, TEM, TAMIS, rectal neoplasm, oral mechanical bowel preparation, fleet enema, Ottawa bowel prep score
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single center, 2-arm, single blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Fleet Enema | Active comparator | Drug: Fleet EnemaPatient 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. |
| Pico Salax | Active comparator | Drug: Pico-SalaxPatient 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons
Key exclusion criteria (11 listed)
- chronic constipation not well controlled with diet or stool softening agents
- previous pelvic radiation
- inflammatory bowel disease
- repeat transanal surgery for the same lesion
- patient unable to self-administer enemas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fleet Enemastandard pre-op application, see arm description | Drug | Fleet Enema |
| Pico-Salaxstandard pre-op application, see arm description | Drug | Pico Salax |
Primary outcome
Quality of bowel preparation
Time frame: A one-time intra-operative assessment for each patient
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.
5 secondary outcomes
Validation of the modified version of the Ottawa Bowel Prep Scale
Time frame: A one-time intra-operative assessment for each patient by a second blinded surgeon
Time spent cleaning operating field
Time frame: A one-time intra-operative assessment for each patient
Ability to close the surgical defect
Time frame: A one-time intra-operative assessment for each patient
Patient tolerability of preparation
Time frame: A one-time pre-op assessment for each patient the morning of surgery
Post-operative complications
Time frame: At discharge and at 6 weeks post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 30489414Parekh PJ, Oldfield EC 4th, Johnson DA. Bowel preparation for colonoscopy: what is best and necessary for quality? Curr Opin Gastroenterol. 2019 Jan;35(1):51-57. doi: 10.1097/MOG.0000000000000494.
- Background: PubMed 25548470Parra-Blanco A, Ruiz A, Alvarez-Lobos M, Amoros A, Gana JC, Ibanez P, Ono A, Fujii T. Achieving the best bowel preparation for colonoscopy. World J Gastroenterol. 2014 Dec 21;20(47):17709-26. doi: 10.3748/wjg.v20.i47.17709.
- Background: PubMed 10834891Atkin WS, Hart A, Edwards R, Cook CF, Wardle J, McIntyre P, Aubrey R, Baron C, Sutton S, Cuzick J, Senapati A, Northover JM. Single blind, randomised trial of efficacy and acceptability of oral picolax versus self administered phosphate enema in bowel preparation for flexible sigmoidoscopy screening. BMJ. 2000 Jun 3;320(7248):1504-8; discussion 1509. doi: 10.1136/bmj.320.7248.1504.
- Background: PubMed 18181310Ruangsin S, Chowchuvech V. A randomized double-blind controlled trial comparing two forms of enema for flexible sigmoidoscopy. J Med Assoc Thai. 2007 Nov;90(11):2296-300.
- Background: PubMed 7926539Preston KL, Peluso FE, Goldner F. Optimal bowel preparation for flexible sigmoidoscopy--are two enemas better than one? Gastrointest Endosc. 1994 Jul-Aug;40(4):474-6. doi: 10.1016/s0016-5107(94)70213-6.
- Background: PubMed 19136102Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
- Background: PubMed 20883845Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.
- BackgroundAronchick C, Lipschultz W, Wright S. Validation of an instrument to assess colon cleansing. Am J Gastroenterol 1993;94:2667.
- Background: PubMed 15044882Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004 Apr;59(4):482-6. doi: 10.1016/s0016-5107(03)02875-x.
- Background: PubMed 22175055Kao D, Lalor E, Sandha G, Fedorak RN, van der Knoop B, Doornweerd S, van Kooten H, Schreuders E, Midodzi W, Veldhuyzen van Zanten S. A randomized controlled trial of four precolonoscopy bowel cleansing regimens. Can J Gastroenterol. 2011 Dec;25(12):657-62. doi: 10.1155/2011/486084.
- Background: PubMed 24949604Holt EW, Yimam KK, Ma H, Shaw RE, Sundberg RA, Verhille MS. Patient tolerability of bowel preparation is associated with polyp detection rate during colonoscopy. J Gastrointestin Liver Dis. 2014 Jun;23(2):135-40. doi: 10.15403/jgld.2014.1121.232.ewh1.
- Background: PubMed 26886637Kim MJ, Hong CW, Kim BC, Park SC, Han KS, Joo J, Oh JH, Sohn DK. Phase II Randomized Controlled Trial of Combined Oral laxatives Medication for BOwel PREParation (COMBO-PREP study). Medicine (Baltimore). 2016 Feb;95(7):e2824. doi: 10.1097/MD.0000000000002824.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katerina Neumann principal investigator
NSHA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fleet Enema and Pico-Salax in people with Colorectal Neoplasms and Surgery, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katerina Neumann (902 473 3937, katerina.neumann@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of bowel preparation (time frame: A one-time intra-operative assessment for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05148494, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.