Peroral endoscopic myotomy vs laparoscopic myotomy and partial fundoplication for esophageal achalasia: A single-center randomized controlled trial

Table 1 Characteristics of the study population

Variable	Total (n = 40)	Group		P value
		LM-PF (n = 20)	POEM (n = 20)
Male, n (%)	26 (65)	14 (70.0)	12 (60.0)	0.507
Age in yr, mean ± SD	44.55 (13.77)	44.20 (13.21)	44.90 (14.64)	0.875
Etiology of achalasia, n (%)				1.000
Chagas disease	9 (22.5)	4 (20.0)	5 (25.0)
Idiopathic	31 (77.5)	16 (80.0)	15 (75.0)
BMI in kg/m2, mean ± SD	22.78 (4.49)	22.79 (4.41)	22.77 (4.70)	0.988
Eckardt score, median (IQR)	8.00 (6.25-9.00)	8.50 (7.25-9.75)	8.00 (6.00-9.00)	0.478

BMI: Body mass index; IQR: Interquartile range; LM-PF: Laparoscopic myotomy and partial fundoplication; POEM: Peroral endoscopic myotomy.

Table 2 Eckardt scores

Time point	Total (n = 40), median (IQR)	Group		P value1
		LM-PF (n = 20), median (IQR)	POEM (n = 20), median (IQR)
Baseline	8.00 (6.25-9.00)	8.50 (7.25-9.75)	8.00 (6.00-9.00)	0.478
1 mo	0.00 (0.00-1.00)	0.00 (0.00-1.00)	1.00 (0.00-1.00)	0.192
6 mo	0.00 (0.00-1.75)	0.00 (0.00-1.00)	0.50 (0.00-2.00)	0.242
12 mo	0.00 (0.00-1.75)	0.00 (0.00-1.00)	0.50 (0.00-2.00)	0.242

¹Nonparametric Mann-Whitney test.

IQR: Interquartile range; LM-PF: Laparoscopic myotomy and partial fundoplication; POEM: Peroral endoscopic myotomy.

Table 3 Treatment success

Time point	Total (n = 40), n (%)	Group		P value1
		LM-PF (n = 20), n (%)	POEM (n = 20), n (%)
1 mo	40 (100.0)	20 (100.0)	20 (100.0)	-
6 mo	38 (95.0)	20 (100.0)	18 (90.0)	0.487
12 mo	39 (97.50)	20 (100.0)	19 (95.0)	1.000

¹Fisher’s exact test.

LM-PF: Laparoscopic myotomy and partial fundoplication; POEM: Peroral endoscopic myotomy.

Table 4 Reflux esophagitis

Time point	n (%) of Total	Group		P value1
		LM-PF, n (%) of Total	POEM, n (%) of Total
Baseline	1 (2.5) of 40	0 (0.0) of 20	1 (5.0) of 20	1.000
1 mo	5 (13.5) of 37	0 (0.0) of 20	5 (29.4) of 17	0.014
6 mo	11 (32.4) of 34	1 (5.6) of 18	10 (62.5) of 16	< 0.001
12 mo	13 (37.1) of 35	2 (11.1) of 18	11 (64.6) of 17	0.002

¹Fisher’s exact test.

LM-PF: Laparoscopic myotomy and partial fundoplication; POEM: Peroral endoscopic myotomy.

Table 5 Height of the barium column in cm

Variable	Total (n = 40)	Group
		LM-PF (n = 20)	POEM (n = 20)
Height at 1 min
Baseline	17.48 (8.11)	16.97 (6.70)	17.99 (9.46)
1 mo	9.90 (5.88)	11.39 (4.18)	8.42 (6.99)
6 mo	8.91 (4.49)	9.61 (3.72)	8.22 (5.15)
12 mo	10.35 (3.38)	10.98 (2.73)	9.73 (3.90)
Height at 5 min
Baseline	15.31 (8.13)	14.92 (7.06)	15.69 (9.24)
1 mo	5.53 (5.41)	6.30 (4.84)	4.75 (5.95)
6 mo	5.69 (5.14)	5.99 (4.56)	5.39 (5.77)
12 mo	8.31 (4.96)	8.66 (4.92)	7.97 (5.10)

Data are presented as mean ± SD. LM-PF: Laparoscopic myotomy and partial fundoplication; POEM: Peroral endoscopic myotomy.

Table 6 Esophageal manometry results of lower esophageal sphincter pressure in mmHg

Variable	Time point	Total (n = 40)	Group
			LM-PF (n = 20)	POEM (n = 20)
Maximal expiratory pressure	Baseline	25.98 (10.42)	24.53 (9.90)	27.43 (10.98)
	6 mo	10.44 (5.86)	9.93 (5.45)	10.94 (6.34)
	12 mo	10.11 (5.09)	9.34 (4.19)	10.87 (5.85)

Data are presented as mean ± SD. LM-PF: Laparoscopic myotomy and partial fundoplication; POEM: Peroral endoscopic myotomy.

Table 7 Adverse events, length of hospital stay, anesthesia time, and procedure time

Variable	Total (n = 40)	Group		P value
		LM-PF (n = 20)	POEM (n = 20)
Adverse events, n (%)	4 (10.0)	1 (5.0)	3 (15.0)	0.605a
Length of hospital stay in d	3.68 (2.42)	3.95 (3.36)	3.40 (0.75)	0.483b
Anesthesia time in min	240.88 (79.46)	296.75 (56.13)	185.00 (56.89)	< 0.001b
Procedure time in min	157.23 (74.81)	218.75 (50.88)	95.70 (30.47)	< 0.001b

^aFisher’s exact test.

^bStudent’s t-test.

Data are presented as mean ± SD, unless noted otherwise. LM-PF: Laparoscopic myotomy and partial fundoplication; POEM: Peroral endoscopic myotomy.

Table 8 Quality of life

SF-36 domain	Baseline score		P value	Score at 12 mo		P value
	LM-PF (n = 20), median (IQR)	POEM (n = 20), median (IQR)		LM-PF (n = 20), median (IQR)	POEM (n = 20), median (IQR)
Physical functioning	95.00 (70.0-100.0)	77.50 (62.25-95.0)	0.165	100.0 (90.0-100.0)	92.50 (66.25-100.0)	0.183
Role-physical	100.0 (56.25-100.0)	25.0 (0.00-68.75)	0.012	100.0 (100.0-100.0)	100.0 (56.25-100.0)	0.445
Role-emotional	100.0 (33.30-100.0)	33.30 (0.00-66.70)	0.021	100.0 (66.70-100.0)	100.0 (41.65-100.0)	0.640
Vitality	67.5 (46.25-88.75)	52.50 (36.25-65.00)	0.052	85.0 (56.25-100.0)	80.0 (56.25-90.0)	0.341
Mental health	74.0 (54.0-95.0)	58.0 (44.0-75.0)	0.030	94.0 (69.0-100.0)	80.0 (57.0-91.0)	0.174
Social functioning	81.25 (62.50-100.0)	56.25 (37.50-71.88)	0.006	100.0 (78.13-100.0)	93.75 (40.63-100.0)	0.174
Bodily pain	73.75 (49.38-97.50)	62.50 (45.0-79.38)	0.201	90.0 (78.13-100.0)	80.0 (55.0-97.50)	0.142
General health	50.0 (31.25-83.75)	55.0 (41.25-65.0)	0.698	82.50 (61.25-100.0)	67.50 (52.50-100.0)	0.445

IQR: Interquartile range; LM-PF: Laparoscopic myotomy and partial fundoplication; POEM: Peroral endoscopic myotomy; SF-36: Medical Outcomes Study 36-item Short-Form Health Survey.