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| Effect of puboprostatic ligament preservation during robotic-assisted laparoscopic radical prostatectomy on early continence: Randomized controlled trial |
Wattanachai Ratanapornsomponga,Suthep Pacharatakulb,Premsant Sangkuma,Chareon Leenanupana,Wisoot Kongcharoensombata,*( )
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a Division of Urology, Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
b Division of Urology, Department of Surgery, Police Hospital, Bangkok, Thailand |
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Abstract Objective: To prove the effectiveness of puboprostatic ligament-preserving robotic-assisted laparoscopic radical (RARP) on enhancing early continence.
Methods: Ninety-two patients with localized adenocarcinoma of the prostate scheduled for RARP from April 2018 to January 2019 were prospectively single-blinded and randomized into two groups, standard RARP (Group A) and puboprostatic ligament-sparing RARP (Group B). The outcomes were continent status at Foley catheter removal and 3 months after surgery using the score from the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), pad usage, pathological margin status, blood loss, operative time, and complications.
Results: Ninety-six patients were randomized (46 patients in each group), with a mean±SD age of 67.30±6.07 years. There were no differences in baseline characteristics. At 3 months after surgery, ICIQ-UI SF score (mean±SD) in Group A was significantly higher than Group B (8.74±4.28 vs. 6.93±3.96, p=0.038) but no difference at Foley catheter removal. Group A also had a significant higher score for interference with daily life (median [interquartile range, IQR]: 4 [1, 5] vs. 2 [0, 4]; p=0.041) and higher pad use (median [IQR]: 2 [0, 3] vs. 1 [1, 2]; p=0.041) at 3 months. One case in Group A had complete or severe incontinence (>5 pads/day) at 3 months. Groups A and B did not exhibit significant difference in margin status (p=0.828). There were no differences in operative time, blood loss, drain output or complications.
Conclusions: Use of puboprostatic ligament-sparing RARP could be a method to accelerate early continence without affecting the final oncological outcome.
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Received: 31 January 2020
Available online: 07 November 2020
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Corresponding Authors:
Wisoot Kongcharoensombat
E-mail: wisoot2002@hotmail.com
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Robotic-assisted laparoscopic radical prostatectomy. (A) Port placement; (B) Puboprostatic ligaments; (C) Anterior retropubic suspension; (D) Urethra after using collar technique.
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| Data | Total
(n=92) | Group A
(n=46) | Group B
(n=46) | p-Value | | Age, mean±SD, year | 67.36±6.07 | 67.15±6.62 | 67.58±5.52 | 0.733a | | Preoperative PSA, median (range), ng/mL | 9.77 (0.925, 64) | 11 (0.925, 64) | 8.92 (4, 50) | 0.281b | | Clinical risk, n (%) | | Low | 20 (21.74) | 10 (21.74) | 10 (21.74) | 0.486c | | Intermediate | 43 (46.74) | 19 (41.30) | 24 (52.17) | | | High | 29 (31.52) | 17 (36.96) | 12 (26.09) | | | Biopsy grade group, n (%) | | I | 30 (32.61) | 16 (34.78) | 14 (30.43) | 0.360c | | II | 18 (19.57) | 8 (17.39) | 10 (21.74) | | | III | 22 (23.91) | 8 (17.39) | 14 (30.43) | | | IV | 11 (11.96) | 6 (13.04) | 5 (10.87) | | | V | 11 (11.96) | 8 (17.39) | 3 (6.52) | | | DM, n (%) | 21 (22.83) | 8 (17.39) | 13 (28.26) | 0.214c | | CVA, n (%) | 8 (8.70) | 6 (13.04) | 2 (4.35) | 0.267d | | OSA, n (%) | 2 (2.17) | 1 (2.17) | 1 (2.17) | 1.000d | | BMI, mean±SD, kg/m2 | 24.70±3.22 | 24.40±3.39 | 25.00±3.04 | 0.367a | | Smoking, n (%) | 31 (33.70) | 13 (28.26) | 18 (39.13) | 0.270d | | Pathological stages and grades | | T stage, n (%) | | T2 | 50 (54.35) | 23 (50.00) | 27 (58.70) | 0.592c | | T3a | 22 (23.91) | 13 (28.26) | 9 (19.57) | | | T3b | 20 (21.74) | 10 (21.74) | 10 (21.74) | | | Gleason grade group, n (%) | | I | 18 (19.57) | 10 (21.74) | 8 (17.39) | 0.978c | | II | 30 (32.61) | 14 (30.43) | 16 (34.78) | | | III | 18 (19.57) | 9 (19.57) | 9 (19.57) | | | IV | 7 (7.61) | 4 (8.70) | 3 (6.52) | | | V | 19 (20.65) | 9 (19.57) | 10 (21.74) | | | LVI, n (%) | 36 (39.13) | 18 (39.13) | 18 (39.13) | 1.000c | | PNI, n (%) | 68 (73.91) | 32 (69.57) | 36 (78.26) | 0.342c | | Positive LN, n (%) | 4 (4.35) | 3 (6.52) | 1 (2.17) | 0.617d | | Prostate weight, median (IQR), g | 42.35 (23.3-108) | 41 (23.3-89.6) | 44.1 (26.4-108) | 0.271b | | CV nerve sparing, n (%) | | Non-nerve sparing | 6 (6.52) | 4 (8.70) | 2 (4.35) | 0.164c | | Unilateral sparing | 19 (20.65) | 6 (13.04) | 13 (28.26) | | | Bilateral sparing | 67 (72.83) | 36 (78.26) | 31 (67.39) | |
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Baseline characteristics, operative data, clinical and pathological stages and grades.
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| Data | Total
(n=92) | Cut ligament
(n=46) | Preserve ligament
(n=46) | p-Value | | At the time of Foley catheter removal | | Q3: How often do you leak urine? n (%) | | Never | 0 | 0 | 0 | | | About once a week or less often | 3 (3.26) | 3 (6.52) | 0 | | | Two or three times a week | 5 (5.43) | 1 (2.17) | 4 (8.70) | | | About once a day | 11 (11.96) | 3 (2.17) | 8 (17.39) | | | Several times a day | 36 (39.13) | 18 (39.13) | 18 (39.13) | | | All the time | 37 (40.22) | 21 (45.65) | 16 (34.78) | | | Score [0-5], mean (SD) | 4.07 (1.02) | 4.15 (1.09) | 4 (0.94) | 0.477a | | Q4: How much urine do you usually leak? n (%) | | None | 0 | 0 | 0 | | | A small amount | 36 (39.13) | 13 (28.26) | 23 (50.00) | | | A moderate amount | 44 (47.83) | 25 (54.35) | 19 (41.30) | | | A large amount | 12 (13.04) | 8 (17.39) | 4 (8.70) | | | Score [0-4], mean (SD) | 3.47 (1.35) | 3.78 (1.35) | 3.17 (1.30) | 0.030a | | Q5: Overall, how much does leaking urine | | interfere with the everyday life? mean (SD) | 5.70 (2.66) | 6.17 (2.77) | 5.23 (2.50) | 0.092a | | ICIQ-UI SF score [0-21], median (IQR) | 13.26 (4.52) | 14.11 (4.67) | 12.41 (4.23) | 0.071a | | At 3 months | | Q3: How often do you leak urine? n (%) | | Never | 2 (2.17) | 0 | | | | About once a week or less often | 19 (20.65) | 8 (17.39) | 11 (23.91) | | | Two or three times a week | 19 (20.65) | 10 (21.74) | 9 (19.57) | | | About once a day | 25 (27.17) | 10 (21.74) | 15 (32.61) | | | Several times a day | 24 (26.09) | 16 (34.78) | 8 (17.39) | | | All the time | 3 (3.26) | 2 (4.35) | 1 (2.17) | | | Score [0-5], mean (SD) | 2.64 (1.22) | 2.87 (1.20) | 2.41 (1.22) | 0.074b | | Q4: How much urine do you usually leak? n (%) | | None | 2 (2.17) | 0 | 2 (4.35) | | | A small amount | 75 (81.52) | 37 (80.43) | 38 (82.61) | | | A moderate amount | 14 (15.22) | 8 (17.39) | 6 (13.04) | | | A large amount | 1 (1.09) | 1 (2.17) | 0 (0.00) | | | Score [0-4], median (SD) | 2.30 (0.89) | 2.43 (0.93) | 2.17 (0.82) | 0.159a | | Q5: Overall, how much does leaking urine | | interfere with the everyday life (0-10)? | | mean (SD) | 2.90 (2.59) | 3.46 (2.68) | 2.34 (2.39) | | | median (IQR) | 3 (0,5) | 4 (1,5) | 2 (0, 4) | 0.041c | | ICIQ-UI SF score [0-21], median (IQR) | 7.84 (4.20) | 8.74 (4.28) | 6.93 (3.96) | 0.038a | | Pad usage (piece), n (%) | | 0-1 (continence) | 54 (58.70) | 21 (45.65) | 33 (71.74) | 0.036b | | 2-3 (minimal stress incontinence) | 34 (36.96) | 21 (45.65) | 13 (28.26) | | | 4-5 (moderate stress incontinence) | 3 (3.26) | 3 (6.52) | 0 | | | >5 (incontinence) | 1 (1.09) | 1 (2.17) | 0 | | | Pad usage, median (IQR) | 1 (0.5-2) | 2 (0-3) | 1 (1-2) | 0.041c | | Pad usage | | Not used | 23 (25.00) | 12 (26.09) | 11 (23.91) | 0.810 | | At least once | 69 (75.00) | 34 (73.91) | 35 (76.09) | |
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ICIQ-UI SF between Group A and Group B at the time of Foley catheter removal and at 3 months.
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The number of pad use in each group.
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| Data | Total
(n=92) | Group A
(n=46) | Group B
(n=46) | p-Value | | Operative time, median (IQR), min | 130 (60-300) | 135 (90-212) | 120 (60-300) | 0.132a | | Blood loss, median (range), mL | 300 (50, 1600) | 300 (100, 1000) | 300 (50, 1600) | 0.780a | | Admit, median (range), day | 6 (4, 101) | 6 (4, 12) | 6 (4, 101) | 0.224a | | Drain output, median (range), mL | 182 (0, 3310) | 170 (0, 3310) | 237 (0, 2030) | 0.474a | | Complication, n (%) | 41 (44.57) | 20 (43.48) | 21 (45.65) | 0.834b | | Blood transfusion, n (%) | 6 (6.52) | 3 (6.52) | 3 (6.52) | 1.000b | | Lymph leak, n (%) | 13 (14.13) | 4 (8.70) | 9 (19.57) | 0.135b | | Fever, n (%) | 21 (22.83) | 12 (26.09) | 9 (19.57) | 0.456b | | UTI, n (%) | 2 (2.17) | 1 (2.17) | 1 (2.17) | 1.000b | | Ileus, n (%) | 3 (3.26) | 0 | 3 (6.52) | 0.242b | | Hematuria, n (%) | 2 (2.17) | 2 (2.17) | 2 (2.17) | 1.000b | | Intraabdominal collection, n (%) | 1 (1.09) | 1 (2.17) | 0 | 0.999b | | AUR, n (%) | 1 (1.09) | 0 | 1 (2.17) | 0.999b | | Scrotal hematoma, n (%) | 1 (1.09) | 1 (2.17) | 0 | 0.999b | | Stroke, n (%) | 1 (1.09) | 0 | 1 (2.17) | 0.999b | | Catheterized time, mean±SD, day | 14.52±4.34 | 15.19±4.61 | 13.84±4.00 | 0.138a | | PSA 3 month, median (range), ng/mL | 0.003
(0.003-1.55) | 0.003
(0.003-1.28) | 0.003
(0.003-1.55) | 0.341a |
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Perioperative and post-operative outcomes.
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| Data | Total
(n=92) | Cut ligament
(n=46) | Preserve ligament
(n=46) | p-Value* | | Margin, n (%) | | Negative | 59 (64.13) | 30 (65.22) | 29 (63.04) | 0.828 | | Positive | 33 (35.87) | 16 (34.78) | 17 (36.96) | | | Margin urethra, n (%) | | Negative | 71 (77.17) | 34 (73.91) | 37 (80.43) | 0.456 | | Positive | 21 (22.83) | 12 (26.09) | 9 (19.57) | |
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Pathological outcomes.
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