Double blinded randomized clinical trial to assess the effectiveness of several preparations for colonoscopy

Cortes, Bruno Giusti Werneck; Cabral, Raquel Martins; Carmo, Guilherme Augusto Alves do; Queiroz, Fábio Lopes de; Leite, Sinara Mônica de Oliveira; Andrade, Amanda Cristina de Souza; Ferreira, Alexandre Silluzio; Alcici, Marta Eugênia; Cortes, Maria da Conceição Juste Werneck

doi:10.1016/j.jcol.2018.07.001

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Original Articles • J. Coloproctol. (Rio J.) 38 (4) • Oct-Dec 2018 • https://doi.org/10.1016/j.jcol.2018.07.001 linkcopy

Double blinded randomized clinical trial to assess the effectiveness of several preparations for colonoscopy

Ensaio clínico randomizado duplo cego para avaliar a eficácia de várias preparações para colonoscopia

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Introduction: Colonoscopy is the screening gold standard to investigate several conditions in the colon. The excellence of preparation is a determining factor for a quality colonoscopy.

Objective: Compare the quality of colon preparations for colonoscopy with different kinds of laxative medications in a public hospital of Belo Horizonte, Brazil.

Method: A prospective double blind randomized clinical trial was conducted from June 2016 to March 2017. A total of 117 Patients were randomised in four groups to receive a type of preparation (Sodium picosulfate, Mannitol, Lactitol, Lactulose). The patients answered a questionnaire and peripheral blood samples were collected before and after the preparation.The quality of the cleansing was accessed according to the Boston Bowel Preparation Scale.

Results: 99.1% of patients have taken the recommended dose and 79.5% reported a good tolerability. Endoscopists performed complete colonoscopy in 89.7%, with an polipectomy rate of 47%. The total effectiveness rate of the solutions were 88%. There were no statistically significant differences between groups (p = 0.271). Regarding the laboratory parameters, differences were seen in the pre- and post-test values of sodium, chlorine and creatinine but without exceeding reference values.

Conclusion: The four preparations were effective for colon cleansing, with good acceptance, differing only as for costs.

Keywords: Colonoscopy; Quality; Bowel preparation; Sodium picosulfate; Mannitol; Lactitol; Lactulose

Variables	Total	Preparation				p
	Total	Lactulose	Lactitol	Mannitol	Sodium picosulfate
	n (%)	n (%)	n (%)	n (%)	n (%)
Gender
Female	83 (70.9)	21 (70.0)	19 (67.9)	20 (71.4)	23 (74.2)	0.959
Male	34 (29.1)	9 (30.0)	9 (32.1)	8 (28.6)	8 (25.8)
Age group (years)
40-50	19 (16.2)	5 (16.7)	6 (21.4)	3 (10.7)	5 (16.1)	0.992
50-59	51 (43.60	14 (46.7)	10 (35.7)	13 (46.4)	14 (45.2)
60-69	36 (30.8)	9 (30.0)	9 (32.1)	9 (32.1)	9 (29.0)
70-79	11 (9.4)	2 (6.7)	3 (10.7)	3 (10.7)	3 (9.7)
Schooling
Complete primary school	20 (17.1)	4 (13.3)	3 (10.7)	8 (28.6)	5 (16.1)	0.242
Incomplete primary school	47 (40.2)	6 (20.0)	17 (60.7)	11 (39.3)	13 (41.9)
Complete secondary school	30 (25.6)	12 (40.0)	5 (17.9)	5 (17.9)	8 (25.8)
Incomplete secondary school	2 (1.7)	1 (3.3)	0 (0.0)	0 (0.0)	1 (3.2)
Complete higher education	10 (8.5)	4 (13.3)	2 (7.1)	3 (10.7)	1 (3.2)
Not able to inform	8 (6.8)	3 (10.0)	1 (3.6)	1 (3.6)	3 (9.7)

Variables	Total	Preparation				p
	Total	Lactulose	Lactitol	Mannitol	Picosulfate
	n (%)	n (%)	n (%)	n (%)	n (%)
Comorbidities
SAH	52 (44.4)	11 (36.7)	16 (57.1)	12 (42.9)	13 (41.9)	0.445
DM	23 (19.7)	4 (13.3)	7 (25.0)	6 (21.4)	6 (19.4)	0.724
Hypothyroidism	16 (13.7)	2 (6.7)	6 (21.4)	4 (14.3)	4 (12.9)	0.440
GERD	12 (10.3)	4 (13.3)	2 (7.1)	4 (14.3)	2 (6.5)	0.663
CHF	1 (0.9)	0 (0.0)	0 (0.0)	1 (3.6)	0 (0.0)	0.361
Dyslipidemia	15 (12.8)	3 (10.0)	7 (25.0)	2 (7.1)	3 (9.7)	0.171
Depression	4 (3.4)	1 (3.3)	1 (3.6)	0 (0.0)	2 (6.5)	0.603
Indication
FOBT+	25 (21.4)	3 (10.0)	8 (28.6)	7 (25.0)	7 (22.6)	0.331
Age > 50 years	21 (17.9)	3 (10.0)	6 (21.4)	6 (21.4)	6 (19.4)	0.617
Haematochezia	19 (16.2)	7 (23.3)	3 (10.7)	5 (17.9)	4 (12.9)	0.563
Post polypectomy follow-up	16 (13.7)	4 (13.3)	3 (10.7)	6 (21.4)	3 (9.7)	0.561
Family history +	14 (12.0)	6 (20.0)	4 (14.3)	2 (7.1)	2 (6.5)	0.321

Variables	Total	Preparation				p
	Total	Lactulose	Lactitol	Mannitol	Picosulfate
	n (%)	n (%)	n (%)	n (%)	n (%)
Colonoscopy
Cecum	48 (41.0)	9 (30.0)	13 (46.4)	11 (39.3)	15 (48.4)
Ileum	57 (48.7)	18 (60.0)	11 (39.3)	15 (53.6)	13 (41.9)	0.862
Incomplete	12 (10.3)	3 (10.0)	4 (14.3)	2 (7.1)	3 (9.7)
Tumor	5 (4.3)	2 (6.7)	1 (3.6)	1 (3.6)	1 (3.2)
Polyps	55 (47)	12 (42)	16 (53)	15 (50)	14 (45)
LST	2 (1.7)	0 (0)	0 (0)	2 (1.7)	0 (0)
Diverticula	32 (27.4)	8 (26.7)	8 (28.6)	8 (28.6)	8 (25.8)

Variables	Total	Preparation				p
	Total	Lactulose	Lactitol	Mannitol	Picosulfate
	n (%)	n (%)	n (%)	n (%)	n (%)
Ascending colon and cecum
Inappropriate/bad	4 (3.4)	0 (0.0)	1 (3.6)	2 (7)	1 (3)	0.754
Good/excellent	104 (88.9)	28 (93.3)	24 (85.70	25 (86)	27 (87)
Not testined	9 (7.7)	2 (6.7)	3 (10.7)	1 (3.6)	3 (9.7)
Transverse colon
Inappropriate/bad	4 (3.4)	0 (0.0)	1 (3.6)	2 (7.1)	1 (3.2)	0.628
Good/excellent	105 (89.7)	29 (96.7)	24 (85.7)	25 (89.3)	27 (87.1)
Not testined	8 (6.8)	1 (3.3)	3 (10.7)	1 (3.6)	3 (9.7)
Descending colon
Inappropriate/bad	6 (5.1)	0 (0.0)	3 (10.7)	1 (3.6)	2 (6.5)	0.574
Good/excellent	108 (92.3)	29 (96.7)	24 (85.7)	26 (92.9)	29 (93.5)
Not testined	3 (2.6)	1 (3.3)	1 (3.6)	1 (3.6)	0 (0.0)
Total
1-5	14 (12.0)	1 (3.3)	4 (14.3)	3 (10.7)	6 (19.4)	0.271
6-9	103 (88.0)	29 (96.7)	24 (85.7)	25 (89.3)	25 (80.6)

Variable	Preparation	Measurement	n	Mean	SD	Minimum	Maximum	p
Na (mmoL/L)	Lactulose	Pre-test	24	139.08	2.19	135.00	143.00	0.922
	Lactulose	Post-test	24	139.00	4.10	131.00	148.00	0.922
	Lactitol	Pre-test	23	139.65	2.55	135.00	145.00	0.329
	Lactitol	Post-test	23	140.48	3.49	135.00	148.00	0.329
	Mannitol	Pre-test	20	139.50	1.88	136.00	143.00	0.211
	Mannitol	Post-test	20	140.45	3.56	133.00	147.00	0.211
	Sodium picosulfate	Pre-test	23	139.43	2.87	132.00	145.00	0.055
	Sodium picosulfate	Post-test	23	137.70	3.66	128.00	143.00	0.055
	Total	Pre-test	90	139.41	2.38	132.00	145.00	0.916
	Total	Post-test	90	139.37	3.83	128.00	148.00	0.916
Chlorine	Lactulose	Pre-test	24	102.71	2.73	98.00	109.00	0.589
	Lactulose	Post-test	24	102.29	3.20	95.00	109.00	0.589
	Lactitol	Pre-test	23	103.52	2.57	100.00	108.00	0.880
	Lactitol	Post-test	23	103.65	3.23	99.00	113.00	0.880
	Mannitol	Pre-test	20	103.55	2.33	100.00	109.00	0.384
	Mannitol	Post-test	20	102.85	3.23	97.00	111.00	0.384
	Sodium picosulfate	Pre-test	24	103.38	3.16	95.00	109.00	<0.001
	Sodium picosulfate	Post-test	24	99.67	3.90	90.00	108.00	<0.001
	Total	Pre-test	91	103.27	2.71	95.00	109.00	0.004
	Total	Post-test	91	102.07	3.68	90.00	113.00	0.004
Creatinine	Lactulose	Pre-test	24	0.88	0.20	0.60	1.30	0.001
	Lactulose	Post-test	24	0.99	0.20	0.60	1.40	0.001
	Lactitol	Pre-test	20	0.88	0.22	0.60	1.50	0.107
	Lactitol	Post-test	20	0.92	0.19	0.60	1.30	0.107
	Mannitol	Pre-test	19	0.84	0.19	0.50	1.10	0.005
	Mannitol	Post-test	19	1.00	0.16	0.80	1.30	0.005
	Sodium picosulfate	Pre-test	19	0.81	0.18	0.60	1.30	0.301
	Sodium picosulfate	Post-test	19	0.85	0.17	0.60	1.30	0.301
	Total	Pre-test	82	0.86	0.20	0.50	1.50	<0.001
	Total	Post-test	82	0.94	0.19	0.60	1.40	<0.001

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