TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

NCT05148494 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Protocol v2
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Colorectal Neoplasms; Surgery

Keywords

transanal endoscopic surgery; TEM; TAMIS; rectal neoplasm; oral mechanical bowel preparation; fleet enema; Ottawa bowel prep score

Outcome Measures

Primary Outcomes (1)

• 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.

  A one-time intra-operative assessment for each patient

Secondary Outcomes (5)

• Validation of the modified version of the Ottawa Bowel Prep Scale

  A one-time intra-operative assessment for each patient by a second blinded surgeon

• Time spent cleaning operating field

  A one-time intra-operative assessment for each patient

• Ability to close the surgical defect

  A one-time intra-operative assessment for each patient

• Patient tolerability of preparation

  A one-time pre-op assessment for each patient the morning of surgery

• Post-operative complications

  At discharge and at 6 weeks post-operatively

Study Arms (2)

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.

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.

Drug: Pico-Salax

Interventions

Fleet Enema DRUG

standard pre-op application, see arm description

Fleet Enema

Pico-Salax DRUG

standard pre-op application, see arm description

Pico Salax

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Victoria General Hospital

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

Related Publications (16)

• 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.

  PMID: 30489414 BACKGROUND

• Parra-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.

  PMID: 25548470 BACKGROUND

• Atkin 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.

  PMID: 10834891 BACKGROUND

• Ruangsin 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.

  PMID: 18181310 BACKGROUND

• Preston 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.

  PMID: 7926539 BACKGROUND

• Lai 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.

  PMID: 19136102 BACKGROUND

• Calderwood 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.

  PMID: 20883845 BACKGROUND

• Aronchick C, Lipschultz W, Wright S. Validation of an instrument to assess colon cleansing. Am J Gastroenterol 1993;94:2667.

  BACKGROUND

• 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.

  PMID: 15044882 BACKGROUND

• Kao 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.

  PMID: 22175055 BACKGROUND

• Holt 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.

  PMID: 24949604 BACKGROUND

• Kim 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.

  PMID: 26886637 BACKGROUND

• Sharma 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.

  PMID: 9149190 BACKGROUND

• Drew 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.

  PMID: 9315059 BACKGROUND

• Bini 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.

  PMID: 10922094 BACKGROUND

• Fincher RK, Osgard EM, Jackson JL, Strong JS, Wong RK. A comparison of bowel preparations for flexible sigmoidoscopy: oral magnesium citrate combined with oral bisacodyl, one hypertonic phosphate enema, or two hypertonic phosphate enemas. Am J Gastroenterol. 1999 Aug;94(8):2122-7. doi: 10.1111/j.1572-0241.1999.01308.x.

  PMID: 10445538 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

sodium phosphate; Pico-Salax

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Katerina Neumann

  NSHA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katerina Neumann

CONTACT

902 473 3937; katerina.neumann@nshealth.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, colorectal surgeon

Model Details: A single center, 2-arm, single blinded randomized controlled trial

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 8, 2021
• Study Start: March 16, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

CA (1)