outcomes following laparoscopic or robotic assisted ......robotic ventral hernia surgery is safe and...

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Outcomes Following Laparoscopic or Robotic Assisted Ventral Hernia Surgery Aakash Dheri, Richard Harth, David Marr, Darren Mensch, Pharm D Candidates 1 , Clark Gerhart MD 2 , Marie Roke-Thomas, PhD 1 1 Wilkes University, Nesbitt School of Pharmacy, 2 Surgical Specialists, Pennsylvania, USA Objective Robotic ventral hernia surgery is safe and effective with a significant decrease in recurrence rates and conversion to an open procedure, p<.05. The operative time in the Robotic surgery was significantly longer, p < .05, due to the addition of primary closure which was not used in the laparoscopic technique. Length of stay, complications and pain medication after surgery were lower in the robotic procedure, but not significant p > .05. Potential savings in the Robotic surgery is due to the ability to decrease mesh size with primary closure. Additional benefits are expected as our experience as the number of robotic surgeries increase. Background The introduction of minimally invasive surgical techniques for hernia repair has been shown to be an effective means of preventing post- surgical complications, smaller and fewer incisions when compared to open general surgery techniques for the repair of hernias. 1 Laparoscopic surgery requires trans-abdominal sutures and tackers, which is often the cause of post-operative pain. However, the novel robotic single site incision procedure uses intracorporeal suturing of the mesh directly to the fascial edge, bypassing the sutures and tackers associated with pain in traditional therapy. 2 Robotic instrumentation has been developed to allow the surgery to be performed with greater dexterity due to the wrist action articulation of the robotic arms in comparison to the rigid trocar used in traditional laparoscopic surgery. Reports have suggested that robotic instrumentation allows procedures to be performed with similar advantages while reducing complications associated with traditional laparoscopic procedures. 3 Method IRB approval was obtained. 111 patients who underwent daVinci® robotic surgery and 116 laparoscopic ventral hernia patients were chosen as subjects. All procedures were performed at the same acute care hospital and by the same operative surgeon. Patients were excluded from the study if they had multiple procedures, such as concomitant appendectomy, gynecological procedures or cholecystectomy, so comparisons could be made between hernia procedures alone without factors that may alter surgical time, length of stay, or complication rates. Patient medical records at both the hospital and surgical practice were reviewed by medical record number. Information was collected on age, gender, BMI, anesthesia time, procedure time, complications, discharge time, etc., and pain medication given in the recovery room. All pain medication doses were converted to doses of morphine for a true comparison. Discharge time is time from the end of procedure to discharge. Results Robotic (N=111) Robotic % Lap (116) Lap % P Value GENDER Female 78 70.27 91 78.48 0.078 Male 34 30.63 23 19.82 ASA SCORE Mild 52 46.84 58 50 0.411 (overall) Severe 60 54.05 56 48.27 TYPE OF HERNIA Incisional Initial 68/95 71.57 86/110 78.18 *Incisional 0.03 Ventral Primary 0.02 Recurrent 27/95 28.42 24/110 21.81 Primary ventral Initial 16/16 100 6/6 100 Recurrent 0 0 0 0 CONCOMITANT PROCEDURES Yes 36 32.43 45 38.79 0.294 Patient Baseline Characteristics Cost of Ventral Hernia Repairs C.Gerhart, WB General Hospital * The two groups difference both in the number of incisional hernias, as well as the number of ventral primary hernias Results Continued Cost Analysis Primary Outcomes Variables Robotic (N=111) Lap (N=116) P value OPERATIVE TIME (min) 92.15± 53.19 60.38±47.85 <0.0001* BLOOD LOSS (ml) 25.0 (minimal) 25.0 (minimal) -- HOSPITAL STAY (hours) 17.7± 40.29 22.3± 51.7 0.437 REOPERATIONS 6 (5.4%) 7 (6.03%) 0.256 CONVERSIONS 1 (<1%) 7 (6.03%) 0.035* READMISSIONS 6 (5.4%) 9 (7.76%) 0.297 Variables Robotic (N=111) Robotic % Lap (N=116) Lap % P-value POSTOPERATIVE COMPLICATION (DISCHARGE TO 30 DAYS) 2 1.8 4 3.4 0.695 PAIN MEDICATION USE PRIOR TO DISCHARGE 88 79.2 96 82.7 0.372 Primary Safety Outcomes Surgery Years No. of cases aged 2 years since surgery 0-6 months 6-12 months 13-18 months 19-24 months Total # of cases recurred up to 24months % Recurrence P-value Lap 2010- 2012 61 2 2 2 3 9 14.75 0.038 Robotic 2011- 2012 70 2 1 3 4.28 The following cases were chosen based on availability of recurrence data for up to two years following surgical repair. Recurrences 1. Sauerland S, Walgenbach M, Habermalz B, Seiler CM, Miserez M. Laparoscopic versus open surgical techniques for ventral or incisional hernia repair. Cochrane Database of Systematic Reviews. 2011;(3):1-59. 2. Schluender S, Conrad J, Divino CM, Gurland B. Robot-assisted laparoscopic repair of ventral hernia with intracorporeal suturing. Surg Endosc. 2003 Jun;17:1391-95. 3. Pietrabissa A, Sbrana F, Morelli, Badessi F, Pugliese L, Vinci A, Klersy C, Spinoglio G. Overcoming the challenges of single-incision cholecystectomy with robotic single-site technology. Arch Surg. 2012 Aug; 147(8):709-714. References Avg. Size Cost/ cm 2 Total Cost Laparoscopic 286.4 cm 2 $4.1 $1,174 Robotic 147.5 cm 2 $4.1 $605 Savings $569 da Vinci 8 mm da Vinci 5 mm Lap Mesh (assume equal) n/a n/a n/a Fixation (Suture or tackers ) $60 Suture $60 Suture $565 - 1 $1130 - 2 Drapes $200 $200 $0 Trocars (x3 or 4) $80 $80 $150 Hot Shears $340 $0 $0 Harmonic $0 $0 $480 Monopolar or lap tray $0 $0 $120 5 mm Monopolar $0 $227 $0 Needle Driver (2) $440 $400 $0 Total (w/ out mesh) $1,120 $967 $1,315-$1,880 Conclusion To perform a single-institution, single-investigator, retrospective, comparative study to evaluate the safety and performance of the da Vinci S/Si Surgical System for use in robotic-assisted ventral hernia repair, compared to laparoscopic approach. Comparative variables included operative time, blood loss, length of hospital stay, re-admissions, intra- operative complications, postoperative complications, recurrence rates and pain medication prior to discharge.

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Page 1: Outcomes Following Laparoscopic or Robotic Assisted ......Robotic ventral hernia surgery is safe and effective with a significant decrease in recurrence rates and conversion to an

Outcomes Following Laparoscopic or Robotic Assisted Ventral Hernia Surgery

Aakash Dheri, Richard Harth, David Marr, Darren Mensch, Pharm D Candidates1,

Clark Gerhart MD2, Marie Roke-Thomas, PhD1

1Wilkes University, Nesbitt School of Pharmacy, 2 Surgical Specialists, Pennsylvania, USA

Objective

Robotic ventral hernia surgery is safe and effective with a significant decrease in recurrence rates and conversion to an open procedure, p<.05. The operative time in the Robotic surgery was significantly longer, p < .05, due to the addition of primary closure which was not used in the laparoscopic technique. Length of stay, complications and pain medication after surgery were lower in the robotic procedure, but not significant p > .05. Potential savings in the Robotic surgery is due to the ability to decrease mesh size with primary closure. Additional benefits are expected as our experience as the number of robotic surgeries increase.

Background

The introduction of minimally invasive surgical techniques for hernia

repair has been shown to be an effective means of preventing post-

surgical complications, smaller and fewer incisions when compared to

open general surgery techniques for the repair of hernias.1 Laparoscopic

surgery requires trans-abdominal sutures and tackers, which is often the

cause of post-operative pain. However, the novel robotic single site

incision procedure uses intracorporeal suturing of the mesh directly to the

fascial edge, bypassing the sutures and tackers associated with pain in

traditional therapy.2 Robotic instrumentation has been developed to allow

the surgery to be performed with greater dexterity due to the wrist action

articulation of the robotic arms in comparison to the rigid trocar used in

traditional laparoscopic surgery. Reports have suggested that robotic

instrumentation allows procedures to be performed with similar

advantages while reducing complications associated with traditional

laparoscopic procedures.3

Method

IRB approval was obtained. 111 patients who underwent daVinci® robotic

surgery and 116 laparoscopic ventral hernia patients were chosen as

subjects. All procedures were performed at the same acute care hospital

and by the same operative surgeon. Patients were excluded from the

study if they had multiple procedures, such as concomitant

appendectomy, gynecological procedures or cholecystectomy, so

comparisons could be made between hernia procedures alone without

factors that may alter surgical time, length of stay, or complication rates.

Patient medical records at both the hospital and surgical practice were

reviewed by medical record number. Information was collected on age,

gender, BMI, anesthesia time, procedure time, complications, discharge

time, etc., and pain medication given in the recovery room. All pain

medication doses were converted to doses of morphine for a true

comparison. Discharge time is time from the end of procedure to discharge.

Results

Robotic (N=111)

Robotic % Lap

(116) Lap % P Value

GENDER

Female 78 70.27 91 78.48 0.078

Male 34 30.63 23 19.82

ASA SCORE

Mild 52 46.84 58 50

0.411 (overall)

Severe 60 54.05 56 48.27

TYPE OF HERNIA

Incisional

Initial 68/95 71.57 86/110 78.18

*Incisional 0.03

Ventral Primary 0.02

Recurrent 27/95 28.42 24/110 21.81

Primary ventral

Initial 16/16 100 6/6 100

Recurrent 0 0 0 0

CONCOMITANT PROCEDURES Yes 36 32.43 45 38.79 0.294

Patient Baseline Characteristics

Cost of Ventral Hernia Repairs

C.Gerhart, WB General Hospital

* The two groups difference both in the number of incisional hernias, as well as the number of ventral primary hernias

Results Continued

Cost Analysis

Primary Outcomes

Variables

Robotic (N=111)

Lap (N=116)

P value

OPERATIVE TIME (min) 92.15± 53.19 60.38±47.85 <0.0001*

BLOOD LOSS (ml) 25.0 (minimal) 25.0 (minimal) --

HOSPITAL STAY (hours) 17.7± 40.29 22.3± 51.7 0.437

REOPERATIONS 6 (5.4%) 7 (6.03%) 0.256

CONVERSIONS 1 (<1%) 7 (6.03%) 0.035*

READMISSIONS 6 (5.4%) 9 (7.76%) 0.297

Variables Robotic (N=111)

Robotic %

Lap (N=116)

Lap % P-value

POSTOPERATIVE COMPLICATION (DISCHARGE

TO 30 DAYS) 2 1.8 4 3.4 0.695

PAIN MEDICATION USE PRIOR TO DISCHARGE

88

79.2

96

82.7

0.372

Primary Safety Outcomes

Surgery Years No. of cases aged 2 years since surgery

0-6 months

6-12

months

13-18 months

19-24 months

Total # of cases recurred up to

24months

% Recurrence

P-value

Lap

2010-2012

61 2 2 2 3 9 14.75 0.038

Robotic

2011-2012

70 2 1

3

4.28

The following cases were chosen based on availability of recurrence data for up to two years following surgical repair.

Recurrences

1. Sauerland S, Walgenbach M, Habermalz B, Seiler CM, Miserez M.

Laparoscopic versus open surgical techniques for ventral or incisional hernia repair. Cochrane Database of Systematic Reviews. 2011;(3):1-59.

2. Schluender S, Conrad J, Divino CM, Gurland B. Robot-assisted laparoscopic repair of ventral hernia with intracorporeal suturing. Surg Endosc. 2003 Jun;17:1391-95.

3. Pietrabissa A, Sbrana F, Morelli, Badessi F, Pugliese L, Vinci A, Klersy C, Spinoglio G. Overcoming the challenges of single-incision cholecystectomy with robotic single-site technology. Arch Surg. 2012 Aug; 147(8):709-714.

References

Avg. Size Cost/ cm2 Total Cost

Laparoscopic

286.4 cm2 $4.1 $1,174

Robotic

147.5 cm2 $4.1 $605

Savings

$569

Avg. Size Cost/ cm2 Total Cost

Laparoscopic

286.4 cm2 $4.1 $1,174

Robotic

147.5 cm2 $4.1 $605

Savings

$569

da Vinci 8 mm

da Vinci 5 mm

Lap

Mesh (assume equal) n/a n/a n/a

Fixation (Suture or tackers ) $60

Suture $60

Suture $565 - 1

$1130 - 2

Drapes $200 $200 $0

Trocars (x3 or 4) $80 $80 $150

Hot Shears $340 $0 $0

Harmonic $0 $0 $480

Monopolar or lap tray $0 $0 $120

5 mm Monopolar $0 $227 $0

Needle Driver (2) $440 $400 $0

Total (w/ out mesh) $1,120 $967 $1,315-$1,880

Conclusion

To perform a single-institution, single-investigator, retrospective,

comparative study to evaluate the safety and performance of the da Vinci

S/Si Surgical System for use in robotic-assisted ventral hernia repair,

compared to laparoscopic approach. Comparative variables included

operative time, blood loss, length of hospital stay, re-admissions, intra-

operative complications, postoperative complications, recurrence rates

and pain medication prior to discharge.