An inexpensive laparoscopy system for female sterilization CLIFFORD
Baltimore,
R.
WHEELESS,
JR.,
M.D.
Maryland
Luparoscop? has become an established procedure for female sterilization. The cost qf the equipment remains excessively high, thereby reducing its availability to all physicians and patients who desire and need it. We have described an inexpensive-but highl?; effeetizfe-j&ale skerilization system utilizing equipment that .rhouM cost in the rnxg qf $400.00.
FEMALE sterilization by laparoscopy has become an established procedure throughout the United States. It has been estimated that approximately 50,000 laparoscopy sterilizations have been performed in the United States in the last IO years.2 Several factors have reduced the availability of female sterilization via laparoscopy to the entire population who have desired and needed it. One factor was the technique and skill required IO perform laparoscopy sterilization. It has been shown in se\reral clinics within the United States to be a factor that can be overcome by training courses for those practicing gynecologists who did not have laparoscopy as a part of their basic residency training.3 A second factor was the excessive cost of the equipment required for laparoscopy sterilization. The present cost of this equipment reduced the availability of the equipment to many smaller hospitals and frequently allowd the purchase of only one set of equipment for the average community hospital. This factor in turn reduced the number of tubal sterilizations that could be performed in any given community per unit of time. Therefore, we felt that it would be desirable to review the requirements for laparoscopy sterilization and design equipment for this procedure that would be effective and safe, but would reduce the cost of the equipment to the practicing surgeon. This would be especially true for our colleagues in the developing world where the excessive cost of From
the Johnr
Hopkins
laparoscopy sterilization equipment has reduced the number of tubal sterilizations that could be performed. Currently, companies interested in producing the equipment (ACMI, Wolf. MTI, Stortz. and Eder)* have quoted prices for a complete set of equipment necessary to perform female sterilization that ranged from a minimum of $3,300.00 to a maximum of $5,200.00.
The purpose of this paper was to report 30 cases of laparoscopy female sterilization performed with equipment that would cost $400.00 at the retail level.
Materials and method The patient population for this study was derived from the private practice of the author and nonprivate patients from the gynecologic clinic. All patients had requested voluntary female sterilization. They received the standard history, physical examination, hematocrit, urinalysis, and Pap smear prior to the procedure. The age range of the patients was 23 to 42. Their parity ranged from 0 to 11. Their weight ranged from 98 to 217 pounds, lcith an average of 145 pounds. Previous lower abdominal surgery had been performed in 16 per cent of the patient population. All patients were operated upon on an outpatient basis. The patients were asked to report to the hospital *ACMI, York. Wolf, Illinois.
Hospital.
Rmwd
Nozwmbrr
18, 1974.
Accepted
Decrmbrr
18. 1974.
American Richard
MTI. Medical Pennsylvania. Stortz. California.
Reprint reyursts: Clifford R. Wheeless, Jr.. M.D.. The Johns Hopkixx Hospital, Baltimm, Mary!md 21205.
Eder, 727
Karl Eder
Cystoscope
Wolf
Medical
Technology
Makers. Instrument
Company,
Pelham,
tzorp.,
Internationale.
Stortz-Endoscopy-America, Instrument
Inc..
Rosemont,
Inc.. Inc.,
Chicago,
New
Ivyland.
Los Angeles. Illinois.
728 Wheeless
Fig. 1. Photograph within
Fig. 2.
the handle.
of pediatric sigmoidoscope Gas bag with CO2 cartridge.
Artist’s drawing to 3 cm. from uterine completed operation.
of sagittal view showing cornu. (B) retracting
with
modified
obturator
(A) Silicone rubber tube. CC) applyirlg
and light
source
contained
band applicator grasping tube 2 band, and band applicator. (1))
Inexpensive
on the morning of surgery fasting and were released within 2 to 3 hours following surgery. Local anesthesia was used in 94 per cent of the cases and consisted of sedation with 50 to 75 mg. of meperidine (Demerol) with 10 mg. of diazepam (\‘alium) given intravenously on the operating table. The incision sites were anesthetized with 1 per cent lidocaine (Xylocaine) and required from 10 to 20 C.C. General anesthesia was used on 6 per cent of the patients and was generally reserved for those patients with a history of psychiatric difficulties, mental retardation, or for demonstration to large groups of physicians. Six surgeons participated in the surgery, three attending gynecologists and three residents. The equipment used in the procedure consisted of the standard fiberoptic Welch-Allyn* pediatric sigmoidoscope that measured 1 cm. in outer diameter. It was modified by replacing the smooth standard sigmoidoscope obturator with a sharp pyrimidal trocar obturator. The fiberoptic light source for this scope was contained within the handle of the scope (Fig. 1). This eliminated the need for a fiberoptic light box or fiberoptic cable. The handle of the Welch-Allyn pediatric sigmoidoscope was connected to a 9 volt 7 amp. electrical source, thus making battery operation possible. The 9 volt electrical source used in this series was obtained from the standard stepdown transformer that came with the Welch-Allyn sigmoidoscope and utilized 110 volt current, but a 220 volt transformer was available. A tubal occlusion device was used through a second incision in the patient’s abdomen and utilized the silicone rubber band and its applicator as previously described by Yoon and associates4 from this clinic. This basically utilized the Pomeroy operation except that a small silicone rubber band that measured 2 mm. in outside diameter was placed around the base of a knuckle of Fallopian tube instead of the usual catgut structure (Fig. 2). The patients were brought to the operating room from home fasting with no preoperative preparation such as pubic hair shaves, vaginal douches, or vaginal suppositories. They were placed in the modified lithotomy position. A Jacobs tenaculum and Rubin’s cannula were placed in the cervix as though one were performing the standard laparoscopy procedure. The abdomen was prepared and draped in the usual
*Welch-Allyn. York.
Welch
Allyn.
Inc..
Skaneateles
Falls,
New
laparoscopy
for sterilization
729
Fig. 3. Photograph toneum
tubing
of CO2 bag attached to pneumoperiinsufflating patient’s abdomen with C02.
fashion. Then 1 per cent lidocaine (Xylocaine) was infiltrated subcuticularly in the inferior rim of the umbilicus with several cubic centimeters of lidocaine (Xylocaine) placed in the fascia and peritoneum. A second infiltration of lidocaine (Xylocaine) was placed in the lower midline approximately 5 to 6 cm. from the pubic symphysis. Towel clips were placed at 5 and 7 o’clock on the inferior rim of the umbilicus. A 2 mm. incision was made in the inferior rim of the umbilicus. A 16 gauge Touhey needle was inserted through the inferior rim of the umbilicus into the peritoneal cavity. The accuracy of placement was tested by filling the needle with several drops of sterile saline, slightly elevating the abdominal wall, and observing the disappearance of the saline into the peritoneal cavity under negative pressure. A second test for accurate placement of the pneumoperitoneum needle utilized the syringe test. A 20 C.C. syringe filled with sterile saline was attached to the pneumoperitoneum needle and a small volume of saline was injected. Immediate aspiration was performed. If no aspiration was obtained, placement of the pneumoperitoneum needle
730
Wheeless
Fig. 4. Photograph of second clips providing countertraction.
Fig. 5. Second incision trocar midline for 11 mm. incision.
was presumed anesthesia held
to be in the bag
was filled
with
rarbon
had
carbon
to
the
dioxide
patient’s
abdomen
L.
minute
per
moperitoneum mclslon extended and
that
sleeve
with
gas (Fig. hose
was
at a flow (Fig.
in the inferior to 6 mm. The inserted
3).
rate
inferior
this
At
this
slowly
of
approximately point and
rim of the 6 mm. second through
this
inferior
a bag
rim for
was
and
the
inches
the
were
then
used
to tent
1
the
pneu-
mately
the
2 mm.
point
within
The
countertraction.
the
up the
5 to 6 cm.
was trocar
‘I-he then
pediatric inserted
incision
in
countertracCon
lower from
the
second
the
pubic incision
sigmoidoscope through this the
The lower
midline
11 mm.
from
clips
the
second
were
then
incision
through the abdominal was withdrawn several
sleeve. to
through
towel
and
trocar
advanced
towel
sigmoidoscope
of the umbilicus.
a transverse,
umbilicus incision
the
of pediatric midline.
with
trocar and sleeve were inserted wall (Fig. 4). The sharp trocar
bag enter
I-im of umbilicus
Fig. 6. Insertion incision in lower
elevated
to
was withdrac\.n.
through
connectors
needle
allowed
inserted
‘4 standard
1). Such
from
pneumoperitoneum gas
needle
were
cavity.
modified
‘2 L. The
trocar
used to tent up lower
peritoneal
been dioxide
approximately
attached
and sleeve
incision
trocar
sleeve
and
at a point was made
incision
were
approxi-
symphysis.
with its sharp incision and
second
and
midline
At
this
(Fig.
3).
trocar was by using trocar
and
inexpensive laparoscopy for sterilization
Fig. 7. Pediatric sigmoidoscope and (B) gas hose attached.
in place
with
(A)
light
cord
sleeve that had been previously placed inside the peritoneal cavity (Fig. 6), the pediatric trocar and sleeve were inserted into the peritoneal cavity. The sharp trocar of the pediatric sigmoidoscope was removed, and the trap door on the head of the pediatric sigmoidoscope was closed and screwed tightly shut. The gas hose was placed on the gas port of the head of the pediatric sigmoidoscope (Fig. 7). The sharp trocar was removed from the second incision trocar and sleeve, and the silicone rubber band applicator was inserted into the second incision sleeve (Fig. 8). These maneuvers generally released 1 to 1% L. of carbon dioxide gas from the peritoneal cavity, and this gas had to be replaced. The anesthesia bag was again filled with approximately 2 L of carbon dioxide. Small amounts of this gas was allowed to infuse through the sigmoidoscope, being controlled by the screw valve on the anesthesia bag. The surgeon placed his left hand on the Jacob’s tenaculum and Rubin’s cannula and inspected the entire uterus, round ligaments, tubes, and ovaries (Fig. 7). He then maneuvered the uterus into the most advantageous position to visualize the Fallopian tubes. At that point he asked the scrub nurse to hold the Rubin’s cannula in that position. He then transferred his left hand to the pediatric sigmoidoscope and his right hand to the silicone rubber band applicator (Fig. 9). The tongs in the silicone rubber band applicator were extended, and a knuckle of Fallopian tube was selected approximately 1% to 2 cm. from the cornea of the uterus. This knuckle of Fallopian tube was withdrawn into the chamber of the silicone rubber band applicator, and the spring coil mechanism of the silicone rubber band applicator was
Fig. 8. Insertion of second applicator into its sleeve.
incision
silicone
Fig. 9. (A) Left hand on pediatric sigmoidoscope hand on silicone rubber band applicator.
rubber
731
band
and (B) right
released advancing two silicone rubber bands onto the knuckle of the Fallopian tube (Fig. 2). The tongs of the silicone rubber band applicator were then extended a second time, and the knuckle of Fallopian tube was released with a gentle, shaking motion. At that point the Fallopian tube should have looked precisely like the traditional, classical Pomeroy procedure (Fig. 10). The knuckle of the Fallopian tube was noted to blanch white, indicating tubal eschemia. The same procedure was carried out on the opposite Fallopian tube. The instruments were withdrawn from the peritoneal cavity in a slow, twisting motion, allowing all carbon dioxide to escape. The incisions were closed
732
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Fig.
10. Photograph
of silicone
rubber
band
around
a knuckle
ot
Fallopian
tube.
The
round
ligament is anterior
with interrupted, fine catgut sutures. A bandaid applied to each incision. The patient was taken special recovery room, given tea or juice, and charged to her home. She was given a prescription cod&e and aspirin for analgesia, but did not activity restriction.
was to a disfor have
Results All 30 patients were operated upon successfully with the inexpensive laparoscopy system. Of those patients operated upon under local anesthesia, little difference was noted between those patients who had a silicone rubber band placed with the two-incision technique and those patients who had a silicone rubber band placed with the single-incision technique.4 All patients had silicone rubber bands placed on the Fallopian tubes, and no electrocoagulation was performed. However. it would have been possible to utilize this modified pediatric sigmoidoscope in the two-incision electrocoagulation technique. All patients were discharged within 2 to 3 hours following the elective surgical sterilization procedure. Excessive pain was noted in four of the 30 patients that required additional prescriptions of codiene and aspirin for analgesia. Most patients could return to work within 2 to 3 days; however, five of the 30 patients required 4 to 6 days’ absence from work. No case of hemorrhage or gastrointestinal damage was noted in this small series. No pregnancies have been noted to date, but the series has not been followed for a sufficient length of time.
Comment If laparoscopy female sterilization on an outpatient basis under local anesthesia is to be offered to a broad base of the female population, the instruments must be designed inexpensively in order that all physicians qualified to use them can obtain them. Our experience indicated that such a female steriliLation system can be designed around inexpensive instruments that should keep the cost of‘ these instruments in the range of $400. This may have a significant benefit in the developing world. At the present time, all surgeons must rely on a third-party funding agency to supply their equipment. The availabilitv of low-cost instruments to a broad base of the medical profession within any given societ) would allow these surgeons to purchase their own equipment without dependence on third-party institutions. such as the United States Agent) for International Developmrnt. foundatiotls. local governments. etc. By being able to purchase their own equipment, they could incorporate female sterilization as a part of their every day gynecological practice. There is no question that it takes a period of orientation to become used to the view through the pediatric sigmoidoscope. For most operating gynecologists. this adjustment was overcome with the experience of several cases. The pediatric sigmoidoscope had the additional advantage that no lenses were required, which frequently fog up or become defective. as has been our experience
Inexpensive
utilizing laparoscopes equipped with complicated lens systems. The second incision offers both the silicone rubber band, hemoclip, Hulka spring clip, and the traditional second-incision electrocoagulation instrument as possibilities for occluding the Fallopian tubes. The fiberoptic pediatric sigmoidoscope also offers the possibility of inserting it through the cul-de-sac for those gynecologists interested in culdoscopy utilizing the basic technique described by Gutierrez.’ This latter technique was not tested in our series. The instruments described in this small series of patients were easily and inexpensively obtained. Their modification was simple and inexpensive. While this
laparoscopy
for sterilization
733
may not be the final design the various tnanufacturing concerns wish to produce, it does demonstrate that outpatient female sterilization under local anesthesia can be performed with instruments that significantly reduced the over-all cost of the procedure. If accepted, it could make the procedure available to a broader base of the female population who need and desire it. It is hoped that others interested in the tee-hniques of female sterilization will experiment with these instruments and contribute additional ideas toward the goal of making an inexpensive female sterilization kit available to all gynecological surgeons.
REFERENCES
I. Gutierrez.
A. J.: Culdoscopy as an aid to family planning, in Duncan, G. W., Falb, R. D., and Spiedel, J. J.:Female Sterilization: Prognosis for Simplified Outpatient Procedures, New York, 1972, Academic Press, Inc. 2. Hulka, J. L.: Presentation Complications Committee, International Congress of Gynecological Laparoscopy, New Orleans, 1973.
3. Wheeless, C. R.: Laparoscopy techniques: Simplifying teaching, training, and utilization, International Congress of Gynecological Laparoscopy, New Orleans, 1973. 4. Yoon. I. B., Wheeless. C. R., and King, T. M.: A preliminary report on a new laparoscopic sterilization approach: The silicone rubber band technique, AM. J. OBSTET. GYNECOL. 120: 132, 1974.