The Use Of Microendoscopy For Diagnostic And Therapeutic Office Laparoscopy Under Local Anesthesia

INTRODUCTION

Since the first laparoscopy was performed in humans by Jacobaeus in 1910, great strides have been made by surgeons in utilizing this valuable tool.¹ Unfortunately, the expense of performing even diagnostic laparoscopy has become prohibitive. With the high cost of medical care, measures must be taken to decrease this monumental problem. For years, laparoscopy has been performed under local anesthesia with minimal reported complications. ^2,3,4,5,6 In most of the reported cases, a 10 mm trocar was used, especially for tubal sterilization. ^7-12 Complications were reported to be minimal. With this vast experience reported in the literature, a method of simple diagnostic laparoscopy has been proposed. The first few procedures containing a bundle of image fibers 6 microns in diameter were performed with a prototype 1.8mm outer diameter micro-laparoscope developed by Medical Dynamics Inc. (Englewood, Colorado). A more advanced catheter called, "Pixie" microendoscope was provided by Origin Medsystems, Inc., (Menlo Park, Calif.) The depth of field with the Origin Pixie microendoscope is 150mm compared to approximately 25mm with the Medical Dynamics microlaparoscope. The greater depth of field is similar to the field of vision of a diagnostic laparoscope 5 to 10mm in outer diameter. The microendoscope was attached to a video camera with a light source and monitor. A third microendoscopic device, the "Microlaparoscope" (Imagyn Medical, New Jersey), has a depth of field of 100mm, an external diameter of 1.98 mm and resolution similar to a 5mm diagnostic laparoscope. The eye piece of this microlaparoscope can be attached to any video camera system. (see in the instrument section) A fourth microendoscope has been manufactured by Olympus. this instrument has an outer diameter of 3 mm and a custom trocar made by Ethicon. In the last 4 years, every major endoscope company has a line of microlaparoscope and accessory instrumentation. The technology is becoming demanded by physicians, patients and managed health care providers.

INDICATIONS

Because of the lesser expense of local anesthesia and in-office procedures, the indications for microlaparoscopy can be expanded to cover many circumstances.

1. Candidates for second-look laparoscopy for adhesion assessment: In those patients who have had Stage IV endometriosis or adhesive disease treated by laparoscopy or laparotomy, the incidence of postoperative adhesions is extremely high, in the range of at least 90%. Yet, 34% with insignificant or so called "friendly" adhesions would have to undergo an unnecessary laparoscopy if one were to laparoscope all these patients. By using the microlaparoscope in the office, only those patients who need a second look laparoscopy would be required to go to surgery for a more expensive procedure. ^14,15

2. Suspected endometriosis with minimal or no physical findings: Frequently, one may suspect endometriosis but have minimal or no physical findings. Rather than proceed with an diagnostic laparoscopy under general anesthesia, the mircolaparoscope can stage the disease adequately and allow a patient to be treated with medical therapy for minimal or mild endometriosis when the complaint is infertility or pelvic pain.

• Chronic pelvic pain without positive physical findings: Often, a patient presents with chronic pelvic pain but no demonstrable physical and ultrasound findings. ¹⁶ In these patients, the mircolaparoscope will prevent a very unnecessary laparoscopy when the incidence of physical evidence is so unlikely. At the time of the procedure, one can use a microforcep to either touch or pull on adhesions or tissue to minic the pain the patient is having. If the pain can be duplicated, the source of the pain can then be identified. In these cases, the least amount of analgesic used the better. Otherwise the pain localization may not be successful.
• Pain localization: Patients with pelvic pain of unknown etiology can have local anesthetic micro-laparoscopy with the intent of mapping out the area of pain. Touching or grasping areas within the location of the patient’s pain will allow documentation by duplication and demonstrate the potential etiology of the pain.

5. Appendicitis versus pelvicinflammatory disease: One of the more controversial diagnosis to differentiate is that of PID vs. appendicitis. A simple out-patient, local anesthetic procedure can very well remove the doubt as to the proper diagnosis.

6. Questionable bleeding ectopic pregnancy in conjunction with or without methotrexate therapy: Fluctuating HCG levels many times are very confusing and may not match the ultra-sound findings. Also, patients receiving methotrexate will commonly have pain in the adnexa secondary to necrosis of villi rather than rupture of the ectopic. The mircolaparoscope prevents intervening with a diagnostic laparoscopy, compelling removal of the ectopic when continued observation is in order.

7.Post-operative evaluation of neosalpingostomy prior to IVF: The only less invasive method we presently have to evaluate our surgical results of neosalpingostomy is by a hysterosalpingogram. Unfortunately, the hysterosalpingogram will not show the size or degree of opening in the newly created tubal ostium. A small pin point opening frequently can allow as much dye through as a normal ostium. Yet, the prognosis for pregnancy is poor and the success of more surgery on the tube would be limited. This patient would probably have better chance of pregnancy with in vitro fertilization.

8. Monitor hysteroscopic resection of submucous fibroids and septate uterus as well as ablation of the endometrium: On occasion, there may not be a need for a more extensive classic laparoscopy when treating these conditions, therefore, simple mircolaparoscope monitoring during the general anesthetic would be adequate. This observation will able the surgeon to find any ancillary pathology as well as monitor the procedure for possible perforation.

9. Monitor medical therapy for various pelvic diseases: Because of the expense of general anesthesia, there has been no reported sequential monitoring of medical therapy for conditions such as endometriosis, pelvic inflammatory disease or postoperative adhesion formation. Feasibly, the mircolaparoscope could be of extreme benefit in following the treatment of these conditions under specific protocols.

10. Outpatient GIFT or Zift procedures: Unless there is a surgical need to perform a laparoscopy at the time of a Gift or Zift procedure, both of these procedures could be done through an mircolaparoscope, using another micro trocar needle to transfer the gametes or embryos.

11.Suspected ruptured corpus luteum cyst: Too often, a patient is taken to surgery for a laparoscopy suspecting a ruptured cyst. The majority of the time, this process is self limiting and would not require even a laparoscopy. The use of the mircolaparoscope could prevent an needless laparoscopy when there is only a small amount of blood in the pelvis or no significant active bleeding.

12. Tubal sterilization: There are thousands of cases reported on tubal sterilization under local anesthesia. A smaller endoscope would obviously decrease the likelihood of complications as well as provide more than adequate vision for tubal coagulation or other methods of sterilization.

13.Lysis of adhesions: In those patients with filmy or moderate adhesion where a simple lysis can be performed using local anesthesia on the adjacent structures, a successful adhesiolysis can eliminate a general anesthetic procedure for five times the cost and recovery time.

14. Distal tubal neosalpingostomy: Using a microneedle and three 5 mm punctures, in selected cases, the distal hydrosalpinx can be opened and sutured back with 4-0 or 5-0 suture utilizing local anesthesia. As stated above, proper patient selection is necessary since many cases of hydrosalpinx are associated with extensive adhesions. Attempting a major salpingolysis in an office setting many be stepping over the boundaries of safety to the patient.

15. Tubal anastomosis: Although the outcomes of laparoscopic tubal anastomosis have been reported to be less than that of anastomosis at laparotomy, the main obstacle has been the instrumentation and video enhancement. With the use of 3-D camera, specialized microlaparoscopy instruments, the feasibility of this procedure being successful has become more of a reality. However, only in the hands of experienced microlaparoscopists should this procedure be performed. The use of the microlaparoscope and micro instruments under general anesthesia would seem more practical and acceptable than performing the procedure under local anesthesia. The endoscopic approach alone would be difficult, timely and costly enough where very few surgeons would have the talents to anastomosis tubes by laparoscopy.

CONTRAINDICATIONS

Most contraindications for the use of the mircolaparoscope would be the same as those for routine laparoscopy with only a few exceptions.

1. Contraindications, whether medical or surgical, as applied to routine laparoscopy.

2. Enlarged uterus over 12-14 weeks size: Because of the placement of the microlaparoscope in the midline between the symphysis and umbilicus is the most desirable, a large uterus would feasibly get in the way of examination of the adnexa and cul-de-sac. Tubal patency could be evaluated by hysterosalpingogram but the assessment of adhesions could be difficult with the enlarged uterus

3. Obesity: Due to the limited length of the mircolaparoscope, it is obvious that the thickness of the abdominal wall would limit its use.

4. Multiple abdominal incisions: In those patients with multiple abdominal incisions where an open laparoscopy would ordinarily be chosen, an mircolaparoscope inserted in a closed fashion could feasibly be unsafe. In these cases, the 3mm trocar is inserted beneath the 11 or 12^th rib in the midclavicular line with the patient tilted to her right. This is a safe area of access since the spleen rarely is enlarged. If the umbilical area is clear, the large trocar can be inserted. Otherwise, the adhesion can be taken down first then the large trocar inserted.

5. Already planned operative laparoscopy: Any patient on whom one already plans to perform a laparoscopy under general anesthesia, an microlaparoscope would not be indicated since you are planning an operative laparoscopy.

EQUIPMENT

In my practice, the procedure is performed in an outpatient setting either in the hospital minor procedure room or office treatment room. The equipment needed to perform the procedure is the following:

1. Mircolaparoscope system to including a video camera, light source and monitor

2. Pulse oximeter & blood pressure cuff

3. Table capable of Trendelenburg

4. Microlaparoscope verres needle with trocar

5. CO2 insufflator (nitrous oxide is preferred except for sterilization)

6. Sterile drapes & Band-Aids

7. Heplock (18-22 gauge) for injection of IV Versed or valium

8. Betadine prep tray

9. Cohen cannula (any uterine manipulator)

10. Graves speculum

11. Local anesthesia (1%-2% nesacaine)

12. 2mm and 5mm trocars for ancillary instruments (Step Trocar)

13. Bipolar forcep for sterilization

14. Microlaparoscopy instruments

The selection of the proper local anesthetic is based on the procedure to be performed. Since microlaparoscopy is generally a short procedure, one needs to use a drug that is fast acting, mild to moderate potency, and a selection that will allow a significant volume safely. In the above chart and next chart, nesacaine appears to be the best choice. However, if the procedure is potentially longer than usual, one might select marcaine which has a much longer lasting effect. Unfortunately, on can only use up to 200 mgm for the entire procedure. Injecting three or four puncture sites plus adding local within the pelvic cavity may quickly use up the allotted amount of drug. In all cases except for evaluation of pelvic pain one can use more ancillary medication to promote pain relief and use less local anesthetic.

These more potent local anesthetics can be useful for pain relief, but one must watch the maximum amount of drug used. In obese patients or in patients where multiple trocar sites will be used or the anticipation of local anesthesia within the pelvic cavity, the total dose must be carefully monitored. The injections of these anesthetics have to be properly monitored with no intravenous injection allowed. Only a small amount of drug given intravenously can be catastrophic.

The prevention of adverse reactions is primarily related to the dose of the local anesthetic used. As shown in the previous slide, the maximum dose of each anesthetic must be monitored carefully. This factor is, however, potentially tainted by a varied tolerance in each individual. For the most part, it would be best to hedge on a maximum dose of 80% of the recommended dose for injection. The other important factor is that of inadvertent vascular injection. For this reason, it is imperative that one pull back on the syringe prior to injecting any local any where in the body. If blood is obtained, redirect the needle in a different direction. Merely pulling back a few mm still might allow for intravenous contamination of the local anesthetic. If central nervous system symptoms develop, the first sign is usually restlessness, followed by dizziness, tinnitus and blurred vision. In more advanced cases of adverse reactions, the patient will begin to tremor and even convulse with respiratory arrest. These adverse reactions are obviously very uncommon. However, one must have a "crash cart" available in the near vicinity of the minor procedure room if such a complication foes occur.

Equally as uncommon, but a severe reaction, is that relating to the cardiovascular system. One of the first symptoms of cardiovascualr side effects would be that of depression of the myocardium. This would be manifested immediately with the development of hypotension, bradycardia and ventricular arrhythmia. In the more severe cases, cardiac arrest would follow. It is both the cardiovascular and central nervous system adverse reaction potential that requires the use of a pulse oximeter and blood pressure cuff on all patients treated with local anesthetics. This constant monitoring will give one a good deal of comfort in preventing either complication from occurring to a point of respiratory or cardiac arrest. This is also a good reason to have in the near vicinity a "crash cart" available for use. We find that this precaution is mandatory for any office procedure including hysteroscopy, leep procedure, laser of the cervix, colposcopy with cervical biopsies, endometrial biopsy or amniocentesis.

TECHNIQUE

The patient is asked to empty her bladder then she is placed on the table in as deep of Trendelenburg as she can tolerate. A blood pressure cuff and pulse oximeter is attached to the patient's arm and finger. An 21 gauge heplock is inserted into her arm for IV medication. Ten mgm of IM valium is given 15 minutes before the procedure and .4mgm of atropine to prevent a vagal reaction. In most cases, I use Versed 2-6 mg IV titrated prior to making the incision for insertion of the verres needle. Additional valium , Demerol or Versed can be administered as needed. A paracervical block is performed and a Cohen canula in inserted to allow manipulation of the uterus. To prevent injury to the left common iliac vein and for ideal evaluation of the pelvis for diagnosis, pain, or infertility, the Mircrolaparoscope verres needle can be placed midway between the umbilicus and symphysis. This approach would be recommended for those performing the procedure for the first time or in an office setting a significant distance from a hospital. However, when one is comfortable with the procedure, the umbilical placement of the verres needle is preferred. The local anesthesia is injected with a 25 gauge needle down through all layers of the abdomen. A small nick is made in the skin and the verres needle within the mircotrocar sheath is introduced into the abdominal cavity at a 45 degree angle with the uterus being held down by the Cohen cannula. The verres needle is removed from the plastic sheath and a gas extension tube is connected to the carbon dioxide insufflator. Approximately 500-600 cc of carbon dioxide or nitrous oxide, is instilled into the peritoneal cavity. Nitrous oxide for diagnostic procedures because it is less irritating to the peritoneal surfaces and is absorbed rapidly. The pelvic cavity is inspected from one infundibulo-pelvic ligament to the other. One may inspect both anterior and posterior cul-de-sac, appendix and upper abdomen. Photographs can be taken.

Another 2 mm trocar or 5mm "Step Trocar"( InnerDyne, Sunnyvale, CA) may be inserted to aspirate fluid, manipulate viscera perform sterilization with a Kleppinger forcep, lyse adhesions or take cultures or biopsies. The ancillary port can be used to insert a 100 micron laser fiber or button bipolar cautery to incise minimal adhesions or vaporize minimal endometrial implants. For those patients with pelvic pain, the area of the pain can be either touched or pulled on with a microforcep to attempt to duplicate the patients pain. If the pain is duplicated by pulling on an adhesion, the adhesion can be lysed. Following the procedure, the gas is removed before taking the patient out of Trendelenburg and steri-strips are placed over the incision. The patient is allowed to sit up and should be watched for a period of 30 to 45 minutes prior to going home.

Those patients who are candidates for second look laparoscopy can uniquely be evaluated without having to insert a trocar and be laparoscoped in the office. This is made possible by the surgeon inserting a Tenckhoff dialysis catheter into the umbilicus after the initial surgery either by laparoscopy or laparotomy. The catheter is taped on the abdomen with water proof tape and the inside portion of the tubing is cut off two inches below the peritoneal surface. The patient is brought back into the minor procedure room one week later, N instilled into the peritoneal cavity and the microlaparoscope inserted. If the patient needs to be brought back for an operative second-look laparoscope the decision is made at this time. The catheter is removed and the patient is sent home. Local anesthesia is used around the catheter before manipulation and for the paracervical block.

Many authors have advocated the use of "second look" laparoscopy as a therapeutic device to prevent adhesions. Obviously, this procedure does not prevent adhesion but treats those adhesions that form after any surgery. It is a known fact that patients who have significant adhesion at the initial surgery whether treated by laparoscopy or laparotomy, will have a 97% chance of reoccurrence after the primary surgery. However, it also has been shown that only 40--50% of these adhesions need to be lysed since the other 50 or 60% of the patients will not cause pain or infertility as a result of the reformation of the adhesions. In these cases, the adhesions do not involve the tubes or ovaries, therefore unlikely to cause symptoms. Unfortunately one does not know which patient will have the adhesions recur. Only a second look laparoscopy will answer that question. As a result, the expense of bringing a patient back to surgery 3-6 weeks after a primary procedure not only is expensive but an additional risk to the patient. For this reason the use of a Tenckhoff catheter can effectively minimize this concern. At the time of the initial procedure, if the patient is required to have a second look laparoscopy, I insert the Tenckhoff catheter through the umbilicus. I cut the end of the tubing in the peritoneal cavity two inches beneath the underlying peritoneum. The vita disc in the catheter is localized within the subcutaneous tissue. This prevents the descent of bacteria into the abdominal cavity. The tubing on the skin is carefully taped to the skin, covered by a water proof dressing. The patient is brought into the office in one week. time or bring the patient back to surgery for the "second look" laparoscopy.

One of our most difficult diagnosis to make is that of the etiology of chronic pelvic pain. In patients with no obvious physical findings yet experience pain for over three months that is not relieved by standard medical therapy, a look with the microlaparoscope would definitely be beneficial. However, at the time of the endoscopy procedure, one may find only mild or no adhesions or mild endometriosis. Whether these findings would be the cause of cause the chronic pelvic pain is uncertain. A method to determine whether the findings can cause the pain is to insert a second 3 mm trocar in the midline. A 2 mm grasper is used to gently tug on the adhesion or peritoneum over the endometriosis implant and ask the patient if the pain has been duplicated. Even in the absence of pathology, touching the adhesions, ovary, uterus, colon, etc. might elicit the pain. Obviously, it is important for the patient not to be overly sedated so she can appreciate these maneuvers. Therefore, in those patients with chronic pelvic pain I would tend to use more local anesthesia and versed rather than any analgesics so that this information can be obtained.

CLINICAL EXPERIENCE

In early 1993, 46 cases using the mircolaparoscope have been performed and reported. The first 20 were done under general anesthesia for the purpose of determining the safety of the procedure. The proper placement of the catheter and the degree of accuracy was confirmed with the 10 mm diagnostic laparoscope. Twenty six cases have been done under local anesthesia, seven patients for the purpose of determining the presence of adhesions to warrant a second-look laparoscopy, ten patients to diagnosis chronic pelvic pain, four tubal sterilizations and one patient who had her tube coagulated in three places and wanted to know if a tubal anastomosis was feasible or to proceed to IVF.

In the 20 cases performed in operating room in conjunction with a diagnostic laparoscope, correlation was virtually 100% as long as systematic examination of the pelvis was performed in a systematic way. It is best to begin the examination looking at one adnexa, moving the catheter over the tubes and ovaries, anterior and posterior cul-de-sac and paracolic gutters. Indeed the size of the image is small, but all structures can be seen with careful examination. During the comparison of the view with the 10 mm laparoscope, an occasional implant would be missed behind the ovary since the ovary could not easily be moved with the mircolaparoscope. However, when the patient is awake, she can be asked to turn on one side, cough or change positions, which in turn, would move the bowel or adnexa into a different position.

The twenty six patients in the local anesthetic group none had complications and nor significant complaints.^17,18 It is extremely important to use an efficient amount of local in the abdominal layers as well as a local anesthetic " hurricane " spray to anesthetize the cervix and vagina, specially in virginal patients. Only one patient required addition of IV valium during the procedure. The time to perform the procedure was only 25 minutes from the beginning of injection of anesthesia until the patient was moved off the table. The average time to watch the patient after the procedure was approximately forty five minutes. Table 1 compares the mircolaparoscope with a diagnostic laparoscopy in the operating room. One can clearly see the benefits of the mircolaparoscope over a standard laparoscopic procedure. Since 1993 an additional 80 microlaparoscopies have been performed n local and /or conscious sedation. The results as far a resolution, available light, success of the procedure has all remained the same. The patient acceptance is excellent with most patients stating that they would have the procedure done again if it were necessary..

SUMMARY

Because of the increasing costs of operative procedures, with the average inpatient laparoscopic procedure costing between $5000 to $7000, the use of the microlaparoscopes can become both economical and practical. Laparoscopy can be an expensive procedure, cause discomfort and require more time off from work. In contrast, the mircolaparoscope can be inserted under local anesthesia, is a less technical procedure, and is significantly less expensive. Patient acceptance will require education as to the benefits of the procedure and the ease which it can be done. In the long run, the mircolaparoscope can become a widely acceptable for the indications

Local Anesthesia Agents

Low potency Potency Onset Duration max dose(mg)

Procaine (novocaine) 1 1 1 1000

Medium Potency

Mepivacaine (carbocaine) 2 2 1.5 500

Prilocaine (Citnest) 3 1 1.5 500

Cholorprocaine (nesacaine) 4 0.8 0.75 1000

Lidocaine (xylocaine) 4 0.8 1.5 500

Table 1

LOCAL ANESTHETIC AGENTS

High Potency Potency Onset Duration Max dose(mg)

Tetracaine (Pontocaine) 16 2 8 200

Bupivacaine (Marcaine) 16 0.6 8 200

Etidocaine (Duranset) 16 0.04 8 200

Table ll

LOCAL ANESTHETICS
Adverse Reactions

• Dose related
• Rapid Absorption
• Diminished tolerance
• Intravascular injection
• Central nervous system
• Restlessness/anxiety/dizziness
• Tinnitus/blurred vision/tremors
• Convulsions/respiratory arrest

Table lll

LOCAL ANESTHESIA
Adverse Reactions

Cardiovascular System

• Depression of Myocardium
• Hypotension
• Bradycardia
• Ventricular arrhythmias
• Cardiac arrest

Table lV

Second-look Laparoscopy with
Microlaparoscope & Tenckhoff Catheter

• Insert Tenckhoff catheter after surgery
• Tape tubing with water proof tape
• Seven days post-op return for microlaparoscopy
• Insuflate abdomen with N₂O₂
• Inspect for adhesions
• Lysis adhesions through another 3 or 5mm trocar

Table V

Pain Localization

• Diagnostic microlaparoscope
• Second puncture: 2-3 mm trocar
• Grasp adhesions or structures with Microforcep
• Duplication of pain noted
• Biopsies may be taken

Table Vl

MIRCOLAPAROSCOPES VS DIAGNOSTIC LAPAROSCOPY

Microlaparoscope Diagnostic laparoscopy

Operating time 25 minutes 30-90 minutes

Blood Loss 0 variable

Hours in facility 2 hours 6-10 hours

Complications 0 variable

Anesthesia local general

Time off work 3 hours 1-7 days

Cost $1,250 -$1950 $5,000- $7,000

Table 7

• Convenient for Surgeon
• Saves time out of office and traveling time
• Saves time waiting in operative suite at hospital
• Less expensive
• Less inconvenient for the patient, i.e.., admissions process, anesthesia standby, laboratory visit, etc...
• All income to the physician
• Economic Credentialing: lower profile!
• Capitation: a MUST!!
• Office setting
• Tubal sterilization
• Diagnostic study
• Pain mapping
• Infertility evaluation
• Hospital minor procedure room
• Second-look laparoscopy
• Gift and Zift procedures
• Suspect minimal endometriosis or adhesions
• Operating Room
• Appendicitis vs PID
• Ectopic pregnancy post MTX therapy
• Suspected ruptured corpus luteum cyst
• Adnexal torsion
• Suspected endometriosis and pelvic adhesions
• Neosalpingostomy or fimbrioplasty
• Lysis of extensive adhesions

Economic Credentialing

1

Economic Credentialing

88

Economic Credentialing

Dysmenorrhea

86

Economic Credentialing

Multiparity

87

References:

REFERENCES

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11. Peterson, H.B., Hulka, J.F., Spielman, F.J., Lee, S., and Marchbanks, P.A. Local versus general anesthesia for laparoscopic sterilization. A randomized study. Obstet. Gynecol. 70:903-908, 1987

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14. Canis, M., Mage, G. Wattiez, A. Chapron, C. Pouly, J. Bassil, S. Second-look laparoscopy after laparoscopic cystectomy of large ovarian endometriomas. Fertil Steril 58:617-619, 1992

15. Jansen, R.S., Early laparoscopy after pelvic operations to prevent adhesions: safety and efficacy. Fertil Steril 49: 26-31, 1988

16. Steege, J.F., Stout, A.L., and Somkuti, S. G. Chronic pelvic pain in women: toward an integrative model. Obstet. Gynecol. Sur. 48:95-110, 1993

17. Feste, J.R.. Diagnostic Laparoscopy: Outpatient Surgery. Contemporary OB/GYN: 40(8):54- 63;1995.

18. Feste, J.R. The use of optical catheters for diagnostic office laparoscopy: J Reprod 41(5):309-312,1996.