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Comparison of the harmonic scissors and endostapler in laparoscopic supracervical hysterectomy
November 1995, Vol. 3, No. 1 The Journal of the American Association of Gynecologic Laparoscopists
Comparison of the Harmonic Scissorsand Endostapler in Laparoscopic Supracervical Hysterectomy Stephen R. Richards, M.D., and Susan Simpkins, R.N. Abstract
We conducted a retrospective analysis of 29 consecutive patients undergoing laparoscopic supracervical hysterectomy to compare outcomes using the endostapler (15 women) versus harmonic scissors (14). Both instruments resulted in similar outcomes with regard to to operating room time, blood loss, and hospital stay. The harmonic scissors have the advantage of decreasing patient cost compared with the stapler.
Techniques and instruments are continually being developed to allow gynecologic surgeons to convert open laparotomy procedures to laparoscopic ones. Frequently, even though the procedures often are performed on an outpatient basis, these innovations increase costs, mainly secondary to the use of disposable instruments 1,2 Concurrent with the performance of laparoscopic hysterectomies has been renewed interest in the possible advantages of supracervical hysterectomy (LSH). 3-6 Although several methods to procure the pedicle (coagulation, suturing, stapling) are possible, for many surgeons, stapling is technically easier and thus preferred.
The harmonic scalpel has been applied to laparoscopic surgery,7 and harmonic scissors recently were released for clinical use. These instruments could replace electrical and laser energy and also reduce cost by decreasing the cost associated with disposable instruments. Materials and Methods
From March 1993 to August 1994, 29 women underwent LSH performed by one surgeon. The method of pedicle development was by either Endo GIA stapler (U.S. Surgical Corp., Norwalk, CT) or LCS harmonic scissors (Ultracision, Smithfield, RI) with 15
From the Advanced Gynecologic Teaching Unit, Grant Medical Center, and Department of Obstetrics and Gynecology, Ohio State University College of Medicine (Dr. Richards); mad private gynecologic practice, Columbus, Ohio (both authors). Address reprint requests to Stephen R. Richards, M.D., 6100 East Main Street, Suite 107, Columbus, OH 43213-3357; fax 614 759 8403.
87
Comparison of Harmonic Scissors and Endostapler Richardsand Simpkins
TABLE 1. Patient
Demographics
Number of patients Mean (range) age (yrs) Mean (range) weight (kg) Mean (range)vaginal deliveries Mean (range) cesarean deliveries and abdominal surgeries
Staples
Harmonic Scissors
15 41 (31-50) 172 (140-242) 1.13 (0-3) 0.27 (0-2)
14 38 (3048) 150 (107-198) 1.6 (04) 0.60 (0-3)
polydioxanone suture was amputated with unipolar scissors or harmonic scalpel, morcellated, and extracted. When the unmorcellated uterine body was small, it was removed through an extended umbilical incision. No cervical enucleation was performed. The mucosa of the cervical stump was fulgurated laparoscopically with unipolar electrode or the harmonic scalpel. In both groups the procedure corresponded to a type ST IB? If necessary, one or more laparoscopic McCall-type sutures (incorporating the uterosacral ligaments, posterior cervical, and]or vaginal tissue) or Moschcowitz stitches were placed to correct an enterocele.
and 14 patients, respectively, in each group. Outcomes were analyzed retrospectively by reviewing hospital and office records. All patients were screened for the absence of cervical dysplasia. Women with uterine size greater than 14 weeks' gestation were excluded. They all received prophylactic antibiotics. Videolaparoscopy was performed with 12-mm ancillary cannulas placed in the right and left lower quadrants lateral to the inferior epigastric arteries. Cephalad-caudad positioning was determined by uterine size. A midline suprapubic 5-mm cannula was sometimes inserted, especially to facilitate enterocele repair. A HUMI (Unimar, Wilton, CT) uterine manipulator was used to move the uterus. The infundibulopelvic ligament pedicle was dissected with either the stapler or harmonic scissors after anatomy was restored and the ureters were visualized. The pedicle, including the round ligament, usually required one or two stapler loads. Dissection with the harmonic scissors proceeded across the pedicle to the uterine body. The laparoscope was moved to a lower quadrant site and the stapler or harmonic scissors placed through the umbilical site to achieve a parallel placement along the uterus. Bladder dissection was performed by injecting the vesicouterine peritoneum with a dilute vasopressin solution (1:30), and using unipolar scissors or harmonic scalpel to incise and dissect the peritoneum between the contralateral round ligaments. The bladder was then advanced caudally. Dissection was stopped at the level of the uterine artery or just through the ascending branch of the uterine artery. The average number of firings for the stapler was three to four per side. A 0 polydioxanone loop was used to lasso the cervicouterinejunction. Two such sutures were placed after the uterine manipulator was removed. A Semm serrated-edge morcellator (Wisap, Tomball, TX) was placed through a dilated lower quadrant site and the bulk of the body of the uterus was morcellated and extracted. The remaining portion of the lower uterine segment above the
Results
Patients in each group were comparable in age and weight (Table 1). Mean outcomes for the staple and scissors groups, respectively, were as follows: operating room time 127 (range 65-210 min) and 135 minutes (range 85-180 rain); specimen weight 131 (range 27-377 g) and 140 g (range 34-335 g); estimated blood loss 173 (range 75-600 ml) and 244 ml (range 75-500 ml); and hospital stay 1.3 and 1.4 days (Figure 1). There were no statistical differences in estimated blood loss, operative time, or uterine weight between the groups using two-tailed Student's t test at the 95% confidence level (p >0.05). Sample size was sufficient to show a 50% difference among all three values at the 5% level of significance with 95% certainty.9 Surgical indications in the groups were also comparable on a percentage basis (Table 2). The overall immediate complication rate was 14%; all of the events were minor. The late complication of cervical stump bleeding was 7%. Discussion
The ability to convert abdominal hysterctomies to vaginal or laparoscopic procedures eliminates an abdominal incision with subsequent less trauma and quicker 88
November 1995, Vol. 3, No, 1
The Journal of the American Association of Gynecologic Laparoscopists
TABLE 2. Surgical Indications and Complications for the Two Groups
Indications, no. (%) Leiomyoma Endometriosis Abnormal uterine bleeding Pelvic pain Complications Perioperative bleeding Epigastric vessel injury Hematoma Crepitus, face Cyclic bleeding postoperatively
Staples
Harmonic Scissors
4 (27) 2 (13)
4 (29) 2 (14)
8 (53) I (7)
7 (50) 1 (7)
1 0 1
1 1 0
2
0
nal or vaginal hysterectomy, due mainly to the use of disposable instruments, including endostaplers. ~,2 Superimposed costs often include a hospital mark-up on disposables of 100% to 300%. 2 Endostaplers are preferred by many laparoscopic surgeons because they are easy to use, fast, and reliably occlude and incise surgical pedicles hemostatically. The ultrasonically activated harmonic scalpel is applied in various laparoscopic surgeries. In essence, electrical energy from a generator is converted to mechanical energy in a handpiece by a piezoelectric crystal that is transmitted to a blade. The blade vibrates at a frequency of 55,500 Hz, with a blade excursion that is undetectable over a distance of 80 p. Depending on the blade configuration, it can coagulate and cut tissues. No plume is generated and thermal injury is m i n i m a l . 7 The instrument has been used to perform total laparoscopic hysterectomy.l~ In 1993 the laparoscopic cutting scissors, or harmonic scissors, became available for clinical use. They coagulate or cut tissue when the surgeon rotates the blade within the handle on a blunt or sharp surface. The tissue is compressed against the blade by an articulated jaw of inert material. Thus the scisssors can
recovery for the patient. This shortens the hospital stay, and many women return to work much more rapidly. Although a cost savings also would be expected with these technologic advances, in fact, laparoscopic hysterectomy is more expensive than either abdomi-
NO~OF PATIENTS
NO OFADDITIONAL PROCEDURES
MEANOPERTIME (MIN)
MEANEBL(CC)
MEANUTERINE WEIGHT(GMS]
MEANHOSPITAl_ STAY(DAYS)
TOTAL COMPLiCATiONS 0 ~
25 STAPLES
50 []
75
100
125
150
175
HARMONIC SCISSORS
FIGURE 1. Comparison of treatment outcomes for the two groups.
89
200
225
250
Comparison of Harmonic Scissorsand Endostapler Richardsand Simpkins
safely and simultaneously coagulate and cut a surgical pedicle laparoscopically. In addition, although the scissors are disposable, their associated cost saving is significant compared with the endostapler. Assuming no changes other than substituting the scissors for staples, and an average number of staples per side to be three or six per procedure, the cost of an Endo GIA device with load is approximately $250 and per reload is approximately $650 ($130 x 5). The total cost for stapling (without hospital mark-up) would then be $900. In comparison, the cost of the harmonic scissors is $295. The handpiece costs $1000; it can be reused approximately 50 times, or $20/procedure. The cost to use the scissors would therefore be $315/procedure, not including the generator. The cost savings of scissors versus staples is therefore approximately $585/case. In the current series this is a total savings of $8775. (The generator, a durable item that can be used with the harmonic scalpel or other probes, costs approximately $13,000). Some caution should be exercised in interpreting our findings. With one exception, the staple group represented the first cases performed, and the scissors group represented later ones. The later cases reflect an evolution of surgical technique and patient awareness of organ conservation. This would explain the small increase in surgical time in the scissors group secondary to the increased number of laparoscopic culdoplasties. Similarly, the absence of cyclic cervical bleeding in the scissors group reflects an increased attempt to destroy endocervical tissue after this complication was recognized. Both bleeding complications in the scissors group were related to cannula placement, not pedicle procurement. Despite these differences, the overall conclusions me unchanged and surgical outcomes were not statistically different.
References
l. Daniell JF, Kurtz BR, McTavish G, et al: Laparoscopically assisted vaginal hysterectomy. J Reprod Med 38:537-542, 1993 2. Boike GM, Elfstrand EP, DelPriore G, et al: Laparoscopically assisted vaginal hysterectomy in a university hospital: Report of 82 cases and comparison with abdominal and vaginal hysterectomy. Am J Obstet Gynecol 168:1690-1701, 1993 3. Hasson HM: Cervical removal at hysterectomy for benign disease: Risks and benefits. J Reprod Med 38:781-790, 1993 4. Semm K: Hysterectomy via laparotomy or pelviscopy. A new CASH method without colpotomy. Geburtshilfe Frauenhielkd 51:996-1003, 1991 5. Pelosi M, Pelosi MIII: Laparoscopic supracervical hysterectomy using a single-umbilical puncture (mini-laparoscopy). J Reprod Med 37:777-784, 1992 6. Hasson HM, Rotman C, Rana N, et al: Experience with laparoscopic hysterectomy. J Am Assoc Gynecol Laparosc 1:1-11, 1993 7. Amaral JF: Laparoscopic application of an ultrasonically activated scalpel. Gastrointest Endosc Clin North Am 3:381-391, 1993 8. Munro MG, Parker H: A classification system for laparoscopic hysterectomy. Obstet Gynecol 82:624-629, 1993 9. Sokol RR, Rohlf FJ: Biometry, The Principles of Practice of Statistics in Biological Research. San Francisco, WH Creman, 1981, pp 262-265 10. Schwartz RO: Total laparoscopic hysterectomy with the harmonic scalpel. J Gynecol Surg 10:33-34, 1994
90
Comparison of the Harmonic Scissorsand Endostapler in Laparoscopic Supracervical Hysterectomy Stephen R. Richards, M.D., and Susan Simpkins, R.N. Abstract
We conducted a retrospective analysis of 29 consecutive patients undergoing laparoscopic supracervical hysterectomy to compare outcomes using the endostapler (15 women) versus harmonic scissors (14). Both instruments resulted in similar outcomes with regard to to operating room time, blood loss, and hospital stay. The harmonic scissors have the advantage of decreasing patient cost compared with the stapler.
Techniques and instruments are continually being developed to allow gynecologic surgeons to convert open laparotomy procedures to laparoscopic ones. Frequently, even though the procedures often are performed on an outpatient basis, these innovations increase costs, mainly secondary to the use of disposable instruments 1,2 Concurrent with the performance of laparoscopic hysterectomies has been renewed interest in the possible advantages of supracervical hysterectomy (LSH). 3-6 Although several methods to procure the pedicle (coagulation, suturing, stapling) are possible, for many surgeons, stapling is technically easier and thus preferred.
The harmonic scalpel has been applied to laparoscopic surgery,7 and harmonic scissors recently were released for clinical use. These instruments could replace electrical and laser energy and also reduce cost by decreasing the cost associated with disposable instruments. Materials and Methods
From March 1993 to August 1994, 29 women underwent LSH performed by one surgeon. The method of pedicle development was by either Endo GIA stapler (U.S. Surgical Corp., Norwalk, CT) or LCS harmonic scissors (Ultracision, Smithfield, RI) with 15
From the Advanced Gynecologic Teaching Unit, Grant Medical Center, and Department of Obstetrics and Gynecology, Ohio State University College of Medicine (Dr. Richards); mad private gynecologic practice, Columbus, Ohio (both authors). Address reprint requests to Stephen R. Richards, M.D., 6100 East Main Street, Suite 107, Columbus, OH 43213-3357; fax 614 759 8403.
87
Comparison of Harmonic Scissors and Endostapler Richardsand Simpkins
TABLE 1. Patient
Demographics
Number of patients Mean (range) age (yrs) Mean (range) weight (kg) Mean (range)vaginal deliveries Mean (range) cesarean deliveries and abdominal surgeries
Staples
Harmonic Scissors
15 41 (31-50) 172 (140-242) 1.13 (0-3) 0.27 (0-2)
14 38 (3048) 150 (107-198) 1.6 (04) 0.60 (0-3)
polydioxanone suture was amputated with unipolar scissors or harmonic scalpel, morcellated, and extracted. When the unmorcellated uterine body was small, it was removed through an extended umbilical incision. No cervical enucleation was performed. The mucosa of the cervical stump was fulgurated laparoscopically with unipolar electrode or the harmonic scalpel. In both groups the procedure corresponded to a type ST IB? If necessary, one or more laparoscopic McCall-type sutures (incorporating the uterosacral ligaments, posterior cervical, and]or vaginal tissue) or Moschcowitz stitches were placed to correct an enterocele.
and 14 patients, respectively, in each group. Outcomes were analyzed retrospectively by reviewing hospital and office records. All patients were screened for the absence of cervical dysplasia. Women with uterine size greater than 14 weeks' gestation were excluded. They all received prophylactic antibiotics. Videolaparoscopy was performed with 12-mm ancillary cannulas placed in the right and left lower quadrants lateral to the inferior epigastric arteries. Cephalad-caudad positioning was determined by uterine size. A midline suprapubic 5-mm cannula was sometimes inserted, especially to facilitate enterocele repair. A HUMI (Unimar, Wilton, CT) uterine manipulator was used to move the uterus. The infundibulopelvic ligament pedicle was dissected with either the stapler or harmonic scissors after anatomy was restored and the ureters were visualized. The pedicle, including the round ligament, usually required one or two stapler loads. Dissection with the harmonic scissors proceeded across the pedicle to the uterine body. The laparoscope was moved to a lower quadrant site and the stapler or harmonic scissors placed through the umbilical site to achieve a parallel placement along the uterus. Bladder dissection was performed by injecting the vesicouterine peritoneum with a dilute vasopressin solution (1:30), and using unipolar scissors or harmonic scalpel to incise and dissect the peritoneum between the contralateral round ligaments. The bladder was then advanced caudally. Dissection was stopped at the level of the uterine artery or just through the ascending branch of the uterine artery. The average number of firings for the stapler was three to four per side. A 0 polydioxanone loop was used to lasso the cervicouterinejunction. Two such sutures were placed after the uterine manipulator was removed. A Semm serrated-edge morcellator (Wisap, Tomball, TX) was placed through a dilated lower quadrant site and the bulk of the body of the uterus was morcellated and extracted. The remaining portion of the lower uterine segment above the
Results
Patients in each group were comparable in age and weight (Table 1). Mean outcomes for the staple and scissors groups, respectively, were as follows: operating room time 127 (range 65-210 min) and 135 minutes (range 85-180 rain); specimen weight 131 (range 27-377 g) and 140 g (range 34-335 g); estimated blood loss 173 (range 75-600 ml) and 244 ml (range 75-500 ml); and hospital stay 1.3 and 1.4 days (Figure 1). There were no statistical differences in estimated blood loss, operative time, or uterine weight between the groups using two-tailed Student's t test at the 95% confidence level (p >0.05). Sample size was sufficient to show a 50% difference among all three values at the 5% level of significance with 95% certainty.9 Surgical indications in the groups were also comparable on a percentage basis (Table 2). The overall immediate complication rate was 14%; all of the events were minor. The late complication of cervical stump bleeding was 7%. Discussion
The ability to convert abdominal hysterctomies to vaginal or laparoscopic procedures eliminates an abdominal incision with subsequent less trauma and quicker 88
November 1995, Vol. 3, No, 1
The Journal of the American Association of Gynecologic Laparoscopists
TABLE 2. Surgical Indications and Complications for the Two Groups
Indications, no. (%) Leiomyoma Endometriosis Abnormal uterine bleeding Pelvic pain Complications Perioperative bleeding Epigastric vessel injury Hematoma Crepitus, face Cyclic bleeding postoperatively
Staples
Harmonic Scissors
4 (27) 2 (13)
4 (29) 2 (14)
8 (53) I (7)
7 (50) 1 (7)
1 0 1
1 1 0
2
0
nal or vaginal hysterectomy, due mainly to the use of disposable instruments, including endostaplers. ~,2 Superimposed costs often include a hospital mark-up on disposables of 100% to 300%. 2 Endostaplers are preferred by many laparoscopic surgeons because they are easy to use, fast, and reliably occlude and incise surgical pedicles hemostatically. The ultrasonically activated harmonic scalpel is applied in various laparoscopic surgeries. In essence, electrical energy from a generator is converted to mechanical energy in a handpiece by a piezoelectric crystal that is transmitted to a blade. The blade vibrates at a frequency of 55,500 Hz, with a blade excursion that is undetectable over a distance of 80 p. Depending on the blade configuration, it can coagulate and cut tissues. No plume is generated and thermal injury is m i n i m a l . 7 The instrument has been used to perform total laparoscopic hysterectomy.l~ In 1993 the laparoscopic cutting scissors, or harmonic scissors, became available for clinical use. They coagulate or cut tissue when the surgeon rotates the blade within the handle on a blunt or sharp surface. The tissue is compressed against the blade by an articulated jaw of inert material. Thus the scisssors can
recovery for the patient. This shortens the hospital stay, and many women return to work much more rapidly. Although a cost savings also would be expected with these technologic advances, in fact, laparoscopic hysterectomy is more expensive than either abdomi-
NO~OF PATIENTS
NO OFADDITIONAL PROCEDURES
MEANOPERTIME (MIN)
MEANEBL(CC)
MEANUTERINE WEIGHT(GMS]
MEANHOSPITAl_ STAY(DAYS)
TOTAL COMPLiCATiONS 0 ~
25 STAPLES
50 []
75
100
125
150
175
HARMONIC SCISSORS
FIGURE 1. Comparison of treatment outcomes for the two groups.
89
200
225
250
Comparison of Harmonic Scissorsand Endostapler Richardsand Simpkins
safely and simultaneously coagulate and cut a surgical pedicle laparoscopically. In addition, although the scissors are disposable, their associated cost saving is significant compared with the endostapler. Assuming no changes other than substituting the scissors for staples, and an average number of staples per side to be three or six per procedure, the cost of an Endo GIA device with load is approximately $250 and per reload is approximately $650 ($130 x 5). The total cost for stapling (without hospital mark-up) would then be $900. In comparison, the cost of the harmonic scissors is $295. The handpiece costs $1000; it can be reused approximately 50 times, or $20/procedure. The cost to use the scissors would therefore be $315/procedure, not including the generator. The cost savings of scissors versus staples is therefore approximately $585/case. In the current series this is a total savings of $8775. (The generator, a durable item that can be used with the harmonic scalpel or other probes, costs approximately $13,000). Some caution should be exercised in interpreting our findings. With one exception, the staple group represented the first cases performed, and the scissors group represented later ones. The later cases reflect an evolution of surgical technique and patient awareness of organ conservation. This would explain the small increase in surgical time in the scissors group secondary to the increased number of laparoscopic culdoplasties. Similarly, the absence of cyclic cervical bleeding in the scissors group reflects an increased attempt to destroy endocervical tissue after this complication was recognized. Both bleeding complications in the scissors group were related to cannula placement, not pedicle procurement. Despite these differences, the overall conclusions me unchanged and surgical outcomes were not statistically different.
References
l. Daniell JF, Kurtz BR, McTavish G, et al: Laparoscopically assisted vaginal hysterectomy. J Reprod Med 38:537-542, 1993 2. Boike GM, Elfstrand EP, DelPriore G, et al: Laparoscopically assisted vaginal hysterectomy in a university hospital: Report of 82 cases and comparison with abdominal and vaginal hysterectomy. Am J Obstet Gynecol 168:1690-1701, 1993 3. Hasson HM: Cervical removal at hysterectomy for benign disease: Risks and benefits. J Reprod Med 38:781-790, 1993 4. Semm K: Hysterectomy via laparotomy or pelviscopy. A new CASH method without colpotomy. Geburtshilfe Frauenhielkd 51:996-1003, 1991 5. Pelosi M, Pelosi MIII: Laparoscopic supracervical hysterectomy using a single-umbilical puncture (mini-laparoscopy). J Reprod Med 37:777-784, 1992 6. Hasson HM, Rotman C, Rana N, et al: Experience with laparoscopic hysterectomy. J Am Assoc Gynecol Laparosc 1:1-11, 1993 7. Amaral JF: Laparoscopic application of an ultrasonically activated scalpel. Gastrointest Endosc Clin North Am 3:381-391, 1993 8. Munro MG, Parker H: A classification system for laparoscopic hysterectomy. Obstet Gynecol 82:624-629, 1993 9. Sokol RR, Rohlf FJ: Biometry, The Principles of Practice of Statistics in Biological Research. San Francisco, WH Creman, 1981, pp 262-265 10. Schwartz RO: Total laparoscopic hysterectomy with the harmonic scalpel. J Gynecol Surg 10:33-34, 1994
90