Initial Experience With 50 Laparoendoscopic Single Site Surgeries Using a Homemade, Single Port Device at a Single Center

Initial Experience With 50 Laparoendoscopic Single Site Surgeries Using a Homemade, Single Port Device at a Single Center

Urolithiasis/Endourology Initial Experience With 50 Laparoendoscopic Single Site Surgeries Using a Homemade, Single Port Device at a Single Center Hw...

2MB Sizes 0 Downloads 35 Views

Urolithiasis/Endourology

Initial Experience With 50 Laparoendoscopic Single Site Surgeries Using a Homemade, Single Port Device at a Single Center Hwang Gyun Jeon, Wooju Jeong, Cheol Kyu Oh, Enrique Ian S. Lorenzo, Won Sik Ham, Koon Ho Rha and Woong Kyu Han* From the Departments of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul and CHA Bundang Medical Center, CHA University, Seongnam (HGJ), Korea

Abbreviations and Acronyms C-LESS ⫽ conventional LESS LESS ⫽ laparoendoscopic single site surgery R-LESS ⫽ robotic LESS Submitted for publication September 25, 2009. Study received Yonsei Severance Hospital institutional review board approval. * Correspondence: Department of Urology, Yonsei University College of Medicine, 134 Shinchon-dong, Seodaemun-gu, Seoul, 120-752, Korea (telephone: ⫹82-2228-2325; FAX: ⫹82-3122538; e-mail: [email protected]).

Purpose: We report our technique of and initial experience with 50 patients who underwent laparoendoscopic single site surgery using a homemade single port device at a single institution. Materials and Methods: Between December 2008 and August 2009 we performed 50 laparoendoscopic single site surgeries using the Alexis® wound retractor, which was inserted at the umbilical incision. A homemade single port device was made by fixing a size 7½ surgical glove to the retractor outer ring and securing the glove fingers to the end of 3 or 4 trocars with a tie and a rubber band. A prospective study was performed in 50 patients to evaluate outcomes. Results: Of 50 patients 34 underwent conventional laparoendoscopic single site surgery, including radical and simple nephrectomy, and cyst decortication in 8 each, nephroureterectomy in 3, partial nephrectomy and adrenalectomy in 2 each, and partial cystectomy, ureterectomy and ureterolithotomy in 1 each, while 16 underwent robotic laparoendoscopic single site surgery, including partial nephrectomy in 11, nephroureterectomy in 3, and simple and radical nephrectomy in 1 each. Mean patient age was 52 years, mean body mass index was 23.4 kg/m2, mean operative time was 201 minutes and mean estimated blood loss was 201 ml. Four intraoperative complications occurred, including 2 bowel serosal tears, diaphragm partial tearing and conversion to open radical nephrectomy. One case of postoperative bleeding was managed by transfusion. Surgical margins were negative in the 13 patients who underwent partial nephrectomy. Mean hospital stay was 4.5 days (range 1 to 16). Conclusions: Our homemade single port device is cost-effective, provides adequate range of motion and is more flexible in port placement for laparoendoscopic single site surgery than the current multichannel port. Key Words: laparoscopy; instrumentation; gloves, surgical; kidney; ureter

1866

www.jurology.com

WITH advancements in surgical instruments, consideration of cosmesis and trends toward minimal invasiveness the number of LESS procedures has recently increased. LESS has been done for diverse urological diseases and studies of postoperative outcomes show less pain, a short hospital stay and excellent cosmesis.1– 6 Many groups have used a commercially available multichannel trocar, such as the Uni-X™

Single Port and the R-Port™, to perform LESS. However, these port systems have some limitations, in that the choice of trocar size, number and arrangement is limited to a rigid outer ring and a small range of motion. Also, these port systems have not been approved by the Korean Food and Drug Administration. Thus, we used a modified single port introduced by Ryu made with a surgical glove and a

0022-5347/10/1835-1866/0 THE JOURNAL OF UROLOGY® © 2010 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION

Vol. 183, 1866-1872, May 2010 Printed in U.S.A. DOI:10.1016/j.juro.2010.01.023

AND

RESEARCH, INC.

LAPAROENDOSCOPIC SURGERY USING HOMEMADE DEVICE

wound retractor.7 Our homemade single port device allows various trocar sizes (5 to 12 mm), locations and placements (3 to 4 trocars), and provides a larger working space and wide range of motion with less clashing between trocars. We report our techniques of C-LESS and R-LESS using the homemade single port in our initial series of 50 urological procedures.

MATERIALS AND METHODS Patients Between December 2008 and August 2009, 50 patients underwent LESS. The surgical approach (C-LESS or R-LESS) was based on surgeon and patient preference. This study was approved by the institutional review board at Yonsei Severance Hospital, Korea. Various parameters were analyzed, including preoperative diagnosis, surgical indication, operative time, estimated blood loss, intraoperative and postoperative complications, and length of hospital stay.

Surgical Technique Figure 1 shows a schematic representation of the homemade single port and instruments for laparoendoscopic single site right nephrectomy. Under general anesthesia the patient was placed in the semilateral decubitus position. For transperitoneal LESS a 4 cm periumbilical skin incision (2 cm incision for cyst marsupialization) and a 1 cm extended fascial incision were made. We used a small Alexis wound retractor and a surgical glove as the homemade single port device (fig. 2, A). To make a single port similar to a commercial multichannel trocar the inner ring of the wound retractor was inserted at the umbilicus. A homemade single port device was made by fixing and suturing a size 7½ surgical glove to the outer ring of the wound retractor so that it would not fall off and securing the glove fingers to the end of the 3

1867

trocars with a tie and a rubber band using the first, third and fifth glove fingers (fig. 2, B and C). For cyst marsupialization a 2 cm skin incision was made, and 1, 12 mm and 2, 5 mm trocars were used. For left nephrectomy a 4 cm incision was made and 2, 12 mm and 1, 5 mm trocars were used. Sometimes an additional 5 mm port for liver traction was placed in the fourth glove finger for right nephrectomy. Pneumoperitoneum was induced by CO2 gas insufflation to 14 mm Hg. To minimize instrument collision we used a 30-degree downward 5 to 10 mm rigid Roticulator™ laparoscope with conventional articulating laparoscopic instruments. Articulating laparoscopic graspers and dissectors were flexible up to 80 degrees in the abdominal cavity. Radical or simple nephrectomy was done in the same manner as conventional laparoscopic nephrectomy (fig. 2, D). The dissected kidney or mass was placed in a laparoscopic bag and easily removed intact via the umbilical incision without extending the incision in most cases. For R-LESS the homemade single port placement was the same as for C-LESS. Four fingers of a size 7½ surgical glove were used for 2, 12 mm ports (the third and fourth fingers) and 2, 8 mm robotic trocars (the first and fifth fingers) (fig. 3, A). The laparoscope and 2, 8 mm robotic trocars were docked into the homemade single port device and a 12 mm port for suction and irrigation was placed (fig. 3, B). When using this device with robotics, the trocars were placed through the abdominal wall within the wound retractor at the same depth as for conventional port placement. When the robot was docked, it placed the trocars at a fixed point so that the glove and the would retractor were likewise fixed and no problems were experienced with the device. The glove was well away from the entry and exit points of the trocar for the instruments. To maximize triangulation we located a 30-degree upward robotic scope in the upper corner of the incision and 2 robotic arms in the lateral corner of the incision maximally (fig. 3, C). Since 2006, we have performed 66 robotic partial nephrectomies. We recently reported the conventional robotic partial nephrectomy technique.8 The surgical technique for tumor dissection and tissue repair for R-LESS partial nephrectomy was the same as for conventional robotic partial nephrectomy.

RESULTS

Figure 1. Homemade single port and instruments for laparoendoscopic single site right nephrectomy.

Table 1 shows the final diagnosis after C-LESS and R-LESS. Mean patient age was 52 years (range 1 to 79). Mean body mass index was 23.4 kg/m2 (range 14.6 to 31.2). Mean operative time was 201 minutes (range 60 to 440). Mean estimated blood loss was 201 ml (range 50 to 1,100). We used only conventional laparoscopic instruments in most cases with articulating or flexible instruments used only for kidney upper pole dissection in some cases. LESS can be performed without difficulty. Gas leakage did not occur during surgery. Table 2 lists intraoperative and early postoperative data. In 1 case the umbilical incision was extended to retrieve an 8 cm renal mass and final pathological results revealed Ewing’s sarcoma. In 2 C-LESS partial nephrectomies hilar clamping, tumor dissection and

1868

LAPAROENDOSCOPIC SURGERY USING HOMEMADE DEVICE

Figure 2. A, wound retractor was placed through umbilical incision. B, glove was sutured at 4 points of wound retractor. C, homemade single port device was made by securing fingers of size 7½ surgical glove to ends of 3 trocars with rubber band and fixing it to wound retractor external ring. D, laparoscope and laparoscopic instruments for left radical nephrectomy. E, inner photograph shows wound retractor placed in umbilical incision and instruments.

tissue repair with suturing were done in a 7-year-old child with a 5.6 cm renal tumor. Hilar clamping was done and the 1 cm renal tumor was excised with a harmonic scalpel. We did not place surgical drains after LESS except for R-LESS partial nephrectomy. Four intraoperative complications occurred. Two bowel injuries (serosal tearing) occurred upon surgical manipulation of adhesions in 1 case of C-LESS for partial nephrectomy and in 1 of R-LESS for simple nephrectomy. Bowel serosal tearing was sutured via the single port. One diaphragm injury during C-LESS radical nephrectomy was sutured successfully using the single port. After R-LESS for partial nephrectomy the case was converted to open radical

nephrectomy due to delayed bleeding in the hilar vessels. One case of postoperative bleeding was managed by transfusion. Mean length of stay was 4.5 days (range 1 to 16). At a mean followup of 5 months there were no postoperative hernias or delayed complications and cosmesis was excellent. For partial nephrectomy mean ischemia time was 37 minutes (range 30 to 44) for C-LESS and 30.7 minutes (range 16 to 45) for R-LESS. In all 13 partial nephrectomy cases, including 2 of C-LESS and 11 of R-LESS, surgical margins were negative for malignancy. During followup 4 months after surgery there were no delayed bleeding or partial nephrectomy related complications.

LAPAROENDOSCOPIC SURGERY USING HOMEMADE DEVICE

1869

Figure 3. A, 2, 12-mm ports and 2, 8 mm robotic trocars were placed through homemade single port. B, 1 laparoscope and 2, 8 mm robotic trocars were placed through homemade single port. C, intraoperative image.

DISCUSSION With great technical progress visualization during surgery and instrument handling have improved enormously and several researchers have developed techniques to decrease the number of ports required Table 1. LESS procedures and surgical indications or diagnosis in 50 patients Procedure

No. Pts

C-LESS: Radical nephrectomy Simple nephrectomy Cyst marsupialization Nephroureterectomy

34 8 8 8 3

Partial nephrectomy

2

Adrenalectomy Partial cystectomy Ureterolithotomy Ureterectomy R-LESS: Partial nephrectomy

2 1 1 1 16 11

Nephroureterectomy Radical nephrectomy Simple nephrectomy

3 1 1

Indication or Diagnosis (No. pts) Renal cell Ca (7), Ewing’s sarcoma (1) Nonfunctioning kidney Transperitoneal (5), retroperitoneal (3) Vesicoureteral reflux (1) ⫹ ectopic ureter (1) in childhood, transitional cell Ca (1) Angiomyolipoma (1), metanephric adenoma in childhood (1) Leiomyosarcoma (1), pheochromocytoma (1) Urachal remnant Stone Ureteral duplication/ectopic ureter Renal cell Ca (10), xanthogranulomatous pyelonephritis (1) Transitional cell Ca Renal cell Ca Nonfunctioning kidney

for safe laparoscopic surgery.9,10 Traditionally at least 3 or 4 ports were required to complete laparoscopic renal surgery and an additional incision was needed to remove the specimen. LESS is a single port technique through the umbilicus that has additional benefits, such as a decreased number of trocars, decreased postoperative pain and the cosmetic advantage of hiding the operative scar in the umbilicus.1–3 Particularly the operative scar was clearly closed and could barely be seen at physical examination. Our patients were fully satisfied with the appearance of the scars. In urology Canes et al reported the first laparoendoscopic single site nephrectomy in 2007 as an abstract,11 followed shortly thereafter in 2007 by a study by Raman et al.12 Two novel, multichannel commercial trocars are designed specifically for LESS, including the R-Port and the Uni-X single laparoscopic port system. However, to date none of the commercial trocars for LESS have been available in Korea. Thus, we used a homemade single port device consisting of a wound retractor and a surgical glove, which are readily available. Recently Park et al reported the first use of a homemade single port device for surgery for an ectopic ureter in a child in Korea.13 We have now performed LESS for diverse urological diseases and extended the use of C-LESS

1870

LAPAROENDOSCOPIC SURGERY USING HOMEMADE DEVICE

Table 2. LESS intraoperative and postoperative results Procedure

No. Pts

C-LESS: Radical nephrectomy Simple nephrectomy Cyst marsupialization Nephroureterectomy Partial nephrectomy Adrenalectomy Partial cystectomy Ureterolithotomy Ureterectomy R-LESS: Partial nephrectomy Nephroureterectomy Radical nephrectomy Simple nephrectomy

34 8 8 8 3 2 2 1 1 1 16 11 3 1 1

Mean Size (cm)

Mean Operative Time (mins)

Mean Estimated Blood Loss (ml)

Mean Hospital Stay (days)

4.1 — 6.2 — 3.3 5.7 — 2 —

186 217 137 150 220 260 175 310 80

405 74 35 105 60 125 50 210 150

5.5 4.2 2.1 4.2 4.5 3.0 4.0 6.0 3.0

Diaphragm injury (1)

3.7 — 8 —

227 240 273 190

667 110 150 100

5.8 3.0 3.0 7.0

Margin pos (0), transfusion (1), conversion (1)

into R-LESS. This technique does not have the same rigidity and port stability as conventional port placement. The lower end of the port was not inserted into the skin incision and 3 or 4 trocars freely hung at each finger of the glove for C-LESS. Only the mid portion of the camera and instruments passed through the incision. However, rigidity and port angle stability were fully possible with the tissue from skin to peritoneum at the midline incision. The mid portion of the laparoscopic instruments (dissectors, grasper, scissors, hook etc) was located in the tissue margin, which supports the instruments. For R-LESS sufficient rigidity is achieved by placing half of the trocar length into the abdominal wall within the wound retractor. The abdominal wall then serves as a fulcrum during instrument manipulation. In our study the hospital stay after C-LESS or R-LESS was much longer than that reported in the literature. In Korea most patients do not leave the hospital until they can return to normal activity. Also, we wanted to observe the patients to ensure the safety and efficacy of this new technique. Our homemade single port device has several merits. 1) It consists of common equipment and materials readily available in the operating room. Thus, it is more cost-effective than current commercial ports. Wound retractor and trocar use is covered by the Korean national health insurance system. Thus, the medical cost of the laparoscopic instruments with this technique does not exceed $200. Surgeons who cannot use commercial trocars can perform LESS easily using this device. Also, no gas leakage was noted during surgery even in procedures with a longer operative time. 2) The R-Port consists of 1, 12 mm and 2, 5 mm lumina, and the Uni-X system consists of an inverted, cone-shaped, plastic outer unit converging on 3 separate 5 mm inlets. However, different numbers and sizes of instruments can be accommodated with our

Comments (No. pts)

Margin pos (0), bowel injury (1)

Bowel injury (1)

homemade single port device with no difficulty depending on the operation. Operations with 4 trocars in a single incision were easily done without internal and external instrument collision. We did not insert an additional port for tissue retraction and dissection. For R-LESS it was possible to use 4 trocars with 2, 12 mm ports and 2, 8 mm robotic trocars with the homemade single port device. In contrast, Gill et al reported that a 2 mm needlescopic grasper was inserted selectively to aid in tissue retraction and dissection in all cases when using the R-Port in the umbilical area.14 Raman et al reported that single port radical nephrectomy was done with 3 adjacent 5 mm trocars through a single 2.5 cm periumbilical incision.15 An additional 3 mm subxiphoid trocar was used for liver traction for right nephrectomy and specimens were removed through an extension of the umbilical incision for 4 to 6 cm tumors. Kaouk et al controlled the renal hilum by stapling the renal artery and vein individually using a vascular stapler introduced though a 10 mm port inserted at the site of a low Gibson incision.3 3) Range of motion was wide with our homemade single port device. During our early experience we used articulating instruments that were bent up to 80 degrees. However, we changed to conventional laparoscopic instruments due to imperfect torque delivery or surgeon power to push and pull tissue using articulating instruments. We can also perform surgery without crossing the instruments because there is enough space with our homemade single port device. 4) We used the same incision for kidney retrieval without an additional incision. Gill et al retrieved the kidney using a 6 to 7 cm low Pfannenstiel incision during LESS donor nephrectomy.14 Kaouk et al used a 10 mm port inserted at the site of a low Gibson incision and later extended it to 4 cm for intact specimen extraction using an EndoCatch™ bag.3 Additional developments are needed in our homemade single port device. Our homemade device has

LAPAROENDOSCOPIC SURGERY USING HOMEMADE DEVICE

1871

the possibility of surgical glove ballooning with more than 3 hours of operative time. The heads of the disposable Excel™ trocars bumped into each other extra-abdominally, which limited the range of motion of the laparoscopic instruments.16 Furthermore, the trocars were too long to enter together through a single port and they bumped into each other. Shorter laparoscopic trocars with smaller heads could be used to secure a wider range of motion.

simple, reliable, flexible, cost-effective approach to C-LESS or R-LESS. However, close followup is needed to ensure that these benefits persist when applied to a large number of patients. Also, improvements are needed to develop applicable instruments and adapt the technique. Proof of safety, standardization and outcomes of our C-LESS and R-LESS techniques should be investigated in further studies.

CONCLUSIONS

ACKNOWLEDGMENTS

We report our initial clinical experience with CLESS and R-LESS using a homemade single port device. Our homemade single port device provides a

Dong-Su Jang, Department of Anatomy, Yonsei University College of Medicine, assisted with the photographs.

REFERENCES 1. Rane A and Rao P: Single-port-access nephrectomy and other laparoscopic urologic procedures using a novel laparoscopic port (R-port). Urology 2008; 72: 260. 2. Soble JJ and Gill IS: Needlescopic urology: incorporating 2-mm instruments in laparoscopic surgery. Urology 1998; 52: 187. 3. Kaouk JH, Haber GP, Goel RK et al: Single-port laparoscopic surgery in urology: initial experience. Urology 2008; 71: 3. 4. Desai MM, Rao PP, Aron M et al: Scarless single port transumbilical nephrectomy and pyeloplasty: first clinical report. BJU Int 2008; 101: 83.

7. Ryu S: Single port surgery-gastro intestinal experience. In: Proceedings of the Third Mudeung Surgical Symposium, Kwangju, Jeolanam-do, Korea, March 30, 2008. 8. Jeong W, Park SY, Lorenzo EI et al: Laparoscopic partial nephrectomy versus robot-assisted laparoscopic partial nephrectomy. J Endourol 2009; 23: 1457. 9. Piskun G and Rajpal S: Transumbilical laparoscopic cholecystectomy utilizes no incisions outside the umbilicus. J Laparoendosc Adv Surg Tech A 1999; 9: 361.

12. Raman JD, Bensalah K, Bagrodia A et al: Laboratory and clinical development of single keyhole umbilical nephrectomy. Urology 2007; 70: 1039. 13. Park YH, Kang MY, Jeong MS et al: Laparoendoscopic single-site nephrectomy using a homemade single-port device for single-system ectopic ureter in a child: initial case report. J Endourol 2009; 23: 833. 14. Gill IS, Canes D, Aron M et al: Single port transumbilical (E-NOTES) donor nephrectomy. J Urol 2008; 180: 637.

5. Raman JD, Cadeddu JA, Rao P et al: Single-incision laparoscopic surgery: initial urological experience and comparison with natural-orifice transluminal endoscopic surgery. BJU Int 2008; 101: 1493.

10. Castellucci SA, Curcillo PG, Ginsberg PC et al: Single port access adrenalectomy. J Endourol 2008; 22: 1573.

15. Raman JD, Bagrodia A and Cadeddu JA: Singleincision, umbilical laparoscopic versus conventional laparoscopic nephrectomy: a comparison of perioperative outcomes and short-term measures of convalescence. Eur Urol 2009; 55: 1198.

6. Kaouk JH and Palmer JS: Single-port laparoscopic surgery: initial experience in children for varicocelectomy. BJU Int 2008; 102: 97.

11. Canes D, Desai MM, Aron M et al: Transumbilical single-port surgery: evolution and current status. Eur Urol 2008; 54: 1020.

16. Jeong W, Jeon HG, Yu HS et al: Embryonicnatural orifice transluminal endoscopic surgery nephrectomy. Korean J Urol 2009; 50: 609.

EDITORIAL COMMENT These authors present their experience with a unique, homemade, single port surgical device in 50 patients. This experience adds to their initial report of this device.1 This series adds to the growing body of evidence that single port surgery or LESS is feasible and reproducible for urological surgery. The introduction of any new technology or surgical approach brings the concerns of cost and patient benefit into focus. This device appears to be a cost friendly way to perform LESS, although no cost data are included. The homemade device performed well and while it is more in-

volved than opening a package costing several hundred dollars, it is reasonably straightforward to construct. The greater question that remains to be answered by these authors or others regards the proper place of the LESS approach in urological surgery. It is clear we can do this but far less clear that we should. Stephen E. Strup Division of Urology University of Kentucky Lexington, Kentucky

REFERENCE 1. Tai HC, Lin CD, Wu CC et al: Homemade transumbilical port: an alternative access for laparoendoscopic single-site surgery (LESS). Surg Endosc 2009; Epub ahead of print.

1872

LAPAROENDOSCOPIC SURGERY USING HOMEMADE DEVICE

REPLY BY AUTHORS Our device (reference 13 in article)1 is similar to but a bit different from the device reported by Tai et al (reference 1 in comment). Studies on new ports have been performed and published in Korea and Taiwan, but not a commercial port that was approved by the Food and Drug Administration of either country. Unlike commercial ports, our device was designed to maximize the triangulation in limited space, and minimize external and internal clashing. Moreover, the device is economical and practical. Alexis wound

retractor is $75 and the port made in Korea is $40. A procedure using 3 ports and 1 Alexis costs $195. Lastly, LESS is still in the development phase. Reports in the literature show that LESS could be possible to a limited extent in urology. In addition, although there is a significant technical challenge in performing LESS, with more evidence and instrumental development it may become the gold standard for surgical treatment in the more extended urological field.

REFERENCE 1. Han WK, Park YH, Jeon HG et al: The feasibility of laparoscopic single-site nephrectomy: initial experience using home-made single-port device. Urology 2010; Epub ahead of print.