1. SAGES Guidelines for Laparoscopic Surgery During Pregnancy
Steven J. Heneghan MD FACS
Director Mithoefer Center for Rural Surgery
Surgeon in Chief Bassett Healthcare

2. The SAGES Guidelines for the Diagnosis, Treatment, and Use of Laparoscopy for Surgical Problems During Pregnancy
Raymond R. Price MD
Vice-Chairman Dept of Surgery
Intermountain Medical Center
Intermountain Healthcare
Adjunct Assistant Clinical Professor of Surgery
University of Utah
Heidi Jackson MD
Steven Granger MD
Michael Rollins MD
Robert Fanelli MD
William Richardson MD
David Earle MD

3. Guidelines
There is a considerable amount of effort toward standardizing guidelines
Rating the evidence
Rating the recommendations
Avoiding using guidelines to reduce professional competition and a move to having them a resource for both patients and clinicians
There is an effort to have agreement between organizations with regard to guidelines.

4. Guidelines for Laparoscopic Surgery During Pregnancy*
SAGES
1996
Guidelines for Laparoscopic Surgery During Pregnancy*
* 8 guidelines
* 23 guidelines
22 References
175 References
2007
Guidelines for Diagnosis, Treatment, and use of Laparoscopy for Surgical Problems During Pregnancy*

5. Levels of Evidence Level 1
Evidence from properly conducted randomized, controlled trials
Level II
Evidence from controlled trials without randomization
Cohort or case-control studies
Multiple time series, dramatic uncontrolled experiments
Level III
Descriptive case series, opinions of expert panels

6. Scale for Evidence Grading
High-level (level I or II), well-performed studies with uniform interpretation and conclusions by the expert panel
Grade A
High-level, well-performed studies with varying interpretation and conclusion by the expert panel
Grade B
Lower level evidence (level II or less) with inconsistent findings and/or varying interpretations or conclusions by the expert panel
Grade C

7. Guidelines Imaging
1 Ultrasonographic imaging during pregnancy is safe and useful in identifying the etiology of acute abdominal pain in the pregnant patient Level II Grade A
2 Expeditious and accurate diagnosis should take precedence over concerns for ionizing radiation. Radiation dosage should be limited to 5 to 10 rads Level III Grade B
3 CT delivers 2-4 rads which falls below the limit and may be considered an appropriate test Level III Grade B

8. Guidelines Imaging
4 MR Imaging can be performed without IV Gadolinium Level III Grade B
5 Nuclear medicine administration of radio nucleotides can generally be done at safe levels Level III Grade C
6 Intraoperative Cholangiography exposes the mother and fetus to minimal radiation and may be uses selectively during surgery Level III Grade B

9. Changes in Recommendations
1996
2007
Pre- and post-operative
Monitoring Fetus
Intra-operative
Second trimester deferment
Trimester
2nd
1st, 2nd, 3rd
8-12 mm Hg
10-15 mm Hg
Pneumoperitoneum
Serial maternal ABG/ ETCO2
Intra-operative Monitoring
ETCO
Open (Hasson) or Closed (Verres)
Abdominal Access
Open (Hasson)

10. Clinical Scenario 24 yo female 12 weeks pregnant
RUQ abdominal pain every 3-4 days
Occurs after fatty meals
US: multiple stones, no wall thickening
Normal LFT’s, amylase, lipase
“I was told by another surgeon that because I was pregnant, I could not have laparoscopic surgery.”

11. Questions? Should I offer her a cholecystectomy? If laparoscopic:
Timing of surgery?
Open or laparoscopic?
Monitoring of fetus intraoperatively?
If laparoscopic:
What entry technique should be used?
Port placement?
Appropriate level of pneumoperitoneum?
Patient positioning?
Need for OB consultation?
ERCP or intraoperative cholangiogram?

12. Tocolytics Guideline 23: Tocolytics should not be used prophylactically, but should be considered peri-operatively when signs of preterm labor are present in coordination with obstetric consultation (Level I, Grade A).
April 8, $94.8 Million Medical Malpractice Verdict Awarded in New York
A New York jury recently awarded $94.8 million to the mother of an eight-year-old boy who was the victim of medical malpractice. In June 1993, Milargros Jordan went into labor after only twenty-seven weeks of pregnancy. Upon her admittance to St. John's Episcopal Hospital in Brooklyn, Jordan was treated with tocolytic drugs, which help stop contractions. Two days later she returned with ruptured membranes. At this time, the doctors decided not to administer tocolytic drugs or corticosteroids, which help reduce the risk of a fetus developing respiratory distress and brain hemorrhage.
Jordan was transferred to Interfaith Medical Center where doctors also chose not to administer either type of drug.She gave birth days later to Jonathan Perez, who developed cerebral palsy due to a brain hemorrhage. Plaintiff experts testified that if the drugs had been administered to Jordan, the infant would likely not have developed the disorder.
$94.8 million awarded to mother of 8 year-old boy. Failure to use tocolytics.

13. Fetal Heart Monitoring Guideline 21: Fetal heart monitoring should occur pre and postoperatively in the setting of urgent abdominal surgery during pregnancy (Level III, Grade B).
Guideline 21: Fetal heart monitoring should occur pre and postoperatively in the setting of urgent abdominal surgery during pregnancy (Level III, Grade B).
While intra-operative fetal heart rate monitoring was once thought to be the most accurate method to detect fetal distress during laparoscopy, no intra-operative fetal heart rate abnormalities have been reported in the literature [48, 101]. This has led some to recommend preoperative and postoperative monitoring of the fetal heart rate with no increased fetal morbidity having been reported [49, 51].
No intra-operative fetal heart rate abnormalities reported.

14. Long term effects on the children?
Laparoscopy and Trimester of Pregnancy Guideline 9: Laparoscopy can be safely performed during any trimester of pregnancy (Level II, Grade B).
Abortion Rate?
Preterm Delivery Rate?
Long term effects on the children?
Guideline 9: Laparoscopy can be safely performed during any trimester of pregnancy (Level II, Grade B).
Operative intervention may be performed in any trimester if warranted by the patient’s condition. Historical recommendations, which were based on experiences with open surgical procedures during pregnancy, were to delay surgery until the second trimester. These recommendations were thought to minimize the spontaneous abortion rate of surgical intervention during the first trimester which has been reported to be as high as 12% and to avoid preterm labor (up to 40%) when surgery occurs during the third trimester [47]. This experience has not been reproduced in more recent literature reporting on laparoscopic cases. Several recent studies have shown that pregnant patients may undergo laparoscopic surgery safely during any trimester without any appreciated increased risk to the mother or fetus [30, 31, 46, 48-51]. It has been suggested that delaying surgical intervention in patients with symptomatic gallstone disease during pregnancy may lead to further complications of gallstone disease such as acute cholecystitis and gallstone pancreatitis [48, 52-54] which can lead to higher spontaneous abortion rates and preterm labor.
It has been suggested that the gestational age limit for successful completion of laparoscopic surgery during pregnancy is 26 to 28 weeks [35]. This has been refuted by several studies in which laparoscopic cholecystectomy and appendectomy have been successfully performed late in the third trimester [49, 51, 55, 56].
Although laparoscopy can be performed safely in pregnancy with good fetal and maternal outcomes, the long-term effects to the children have not been well studied. One recent study evaluated eleven children from one to eight years and found no growth or developmental delay [42].

15. Non-operative Management Spontaneous Abortions
Gallbladder Disease Guideline 15: Laparoscopic cholecystectomy is the treatment of choice in the pregnant patient with gallbladder disease regardless of trimester (Level II, Grade B).
Non-operative Management
Symptom recurrence
1st %
2nd – 64%
3rd – 44%
Guideline 15: Laparoscopic cholecystectomy is the treatment of choice in the pregnant patient with gallbladder disease regardless of trimester (Level II, Grade B).
Management of symptomatic cholelithiasis in pregnancy has been controversial with some recommending initial non-operative management [52, 95-97]. Those in favor of early surgical management are supported by the recurrence of symptomatic gallstones during pregnancy in 92% of patients managed non-operatively who present in the first trimester, 64% presenting in the second, and 44% in the third [98]. More important than recurrence, this delay in surgical management results in significant morbidity including; increased hospitalizations, spontaneous abortions, preterm labor, and preterm delivery compared to those undergoing cholecystectomy [39, 40, 52, In addition, non-operative management boasts a reported 57% symptom recurrence during pregnancy in patients with biliary colic and a 23% complication rate of acute cholecystitis and gallstone pancreatitis [48]. Gallstone pancreatitis results in fetal loss in 10% to 60% of pregnant patients [99, 100]. The significant morbidity and mortality associated with gallbladder disease in the gravid patient argue in favor of surgical management. When compared to open cholecystectomy, the laparoscopic approach has equivalent outcomes and the well established added benefits of laparoscopy [50]. Improved outcomes with decreased risk of spontaneous abortion and preterm labor have been reported in laparoscopic cholecystectomy when compared to laparotomy [101].
Hospitalizations
Spontaneous Abortions
Pre-term Labor

16. Initial Port Placement Guideline 11: Initial access can be safely accomplished with an open or Hassan, Verres needle or optical trocar if the location is adjusted according to fundal height, previous incisions and experience of the surgeon (Level III, Grade B).
Guideline 11: Initial access can be safely accomplished with open (Hassan), Verres needle or optical trocar technique if the location is adjusted according to fundal height, previous incisions and experience of the surgeon (Level III, Grade B).
There has been much debate regarding abdominal access in the pregnant patient with preferences toward either a Hassan technique or Verres needle. The concern for use of the Verres needle technique has largely been based on concerns for higher likelihood of injury to the uterus or other intra-abdominal organs as fundal height increases [67, 68]. Because the intra-abdominal domain is altered by the increasing fundal height adaptation of the initial access site from the umbilicus to subcostal regions as the uterus enlarges in the second and third trimester has been recommended [49, 51, 55, 62]. If the site of initial abdominal access is adjusted according to fundal height and the abdominal wall is elevated during insertion, both the Hassan technique and Verres needle can be safely and effectively utilized [49, 51, 69].
It has also been recommended that placement of trocars is adjusted according to fundal height and that they are inserted under direct visualization [70, 71]. Ultrasound guided trocar placement has been described in the literature as an additional method to visualize trocar placement [72].

17. Fundal Height by Gestational Age in Weeks8 12 16 20 26 32 36 40
Fundal Height by Gestational Age in Weeks
Figure 1. Fundal height by gestational age in weeks.
Rollins MD, Price RR. Laparoscopic surgery during pregnancy. In: Inderbir SG ed. Textbook of laparoscopic urology. New York: Informa Healthcare USA, Inc., 2006:

18. Trocar Placement for Laparoscopic Appendectomy
Changes by size of gravid uterus. 2 1 3
1st Trimester
3rd Trimester
2nd Trimester
Figure 1. Trocar placement for laparoscopic appendectomy changes by size of gravid uterus. Numbers indicate the order of insertion.
Rollins MD, Price RR. Laparoscopic surgery during pregnancy. In: Inderbir SG ed. Textbook of laparoscopic urology. New York: Informa Healthcare USA, Inc., 2006:

19. Insufflation Pressure Guideline 12: CO2 insufflation of mmHg can be safely used for laparoscopy in the pregnant patient. Intra-abdominal pressure should be sufficient to allow for adequate visualization (Level III, Grade C).
Maternal
Pulmonary
Guideline 12: CO2 insufflation of mmHg can be safely used for laparoscopy in the pregnant patient. Intra-abdominal pressure should be sufficient to allow for adequate visualization (Level III, Grade C).
The potential effects of CO2 insufflation on the pregnant patient and her fetus have led to apprehension over its use. The pulmonary effects of pneumoperitoneum in the pregnant patient and the potential risk for acidosis to the fetus have caused concern and have led some investigators to develop alternative approaches of gasless laparoscopy, but these have not been widely adopted [73-80].
The pregnant patient’s diaphragm is upwardly displaced by the growing fetus, which results in decreased residual lung volume and functional residual capacity making her more susceptible to arterial oxygen desaturation [81]. Upward displacement of the diaphragm by pneumoperitoneum is more worrisome in a pregnant patient with existing restrictive pulmonary physiology. Some have recommended intra-abdominal insufflation pressures be maintained at less than 12 mmHg to avoid worsening pulmonary physiology in this population [71, 82]. Others have argued that insufflation less than 12 mmHg may not provide adequate visualization of the intra-abdominal cavity [49, 51]. Pressures of 15 mmHg have been implemented during laparoscopy in pregnant patients without increasing adverse outcomes to the patient or her fetus [49, 51].
Because CO2 exchange occurs with intraperitoneal insufflation, there has been concern for effects to the fetus, specifically the effects of acidosis. Some animal studies have confirmed fetal acidosis with associated tachycardia, hypertension and hypercapnia during CO2 pneumoperitoneum [83-85]. Other animal studies have demonstrated no fetal acidosis [86]. Regardless, no long-term adverse effects have been identified [83-86]. Of more interest, there is no evidence to support long term detrimental effects resulting from CO2 pneumoperitoneum in humans [35].
Visualization
Fetal
Acidosis

20. Functional Residual Capacity
Maternal
Pulmonary
Residual Volume
Growing fetus
Pressure on diaphragm
Functional Residual Capacity
PaO2
Pressures of 15 mmHg – no increased adverse outcomes to the patient or fetus

21. Devon’s Racing Rams (photo Rick Turner)
Fetal
Animal Studies
CO2 Pneumoperitoneum
Acidosis
Tachycardia Hypertension Hypercapnia
Because CO2 exchange occurs with intraperitoneal insufflation, there has been concern for effects to the fetus, specifically the effects of acidosis. Some animal studies have confirmed fetal acidosis with associated tachycardia, hypertension and hypercapnia during CO2 pneumoperitoneum [83-85]. Other animal studies have demonstrated no fetal acidosis [86]. Regardless, no long-term adverse effects have been identified [83-86]. Of more interest, there is no evidence to support long term detrimental effects resulting from CO2 pneumoperitoneum in humans [35].
Devon’s Racing Rams (photo Rick Turner)
No evidence to support long term detrimental effects resulting from CO2 pneumoperitoneum in humans

22. Capnography adequately reflects maternal acid/base status in humans.
Intra-operative CO2 monitoring Guideline 13: Intra-operative CO2 monitoring by capnography should be used during laparoscopy in the pregnant patient (Level III, Grade C).
Maternal arterial blood gas (PaCO2)
vs.
Guideline 13: Intra-operative CO2 monitoring by capnography should be used during laparoscopy in the pregnant patient (Level III, Grade C).
Fetal acidosis and associated fetal instability in CO2 pneumoperitoneum have been documented in animal studies, though no long-term effects from these changes have been identified [83-85, 87]. Fetal acidosis with insufflation has not been documented in the human fetus, but concerns over potential detrimental effects of acidosis have led to the recommendation of maternal CO2 monitoring [88, 89]. Initially, there was debate over maternal blood gas monitoring of arterial carbon dioxide (PaCO2) versus end-tidal carbon dioxide (ETCO2) monitoring, but the less invasive capnography has been demonstrated to adequately reflect maternal acid/base status in humans [90]. Several large studies have documented the safety and efficacy of EtCO2 measurements in pregnant women [35, 49, 51] making routine blood gas monitoring unnecessary.
End-tidal CO2 (EtCO2)
Capnography adequately reflects maternal acid/base status in humans.

23. Clinical Scenario
ER physician calls you to see a 27 year old 8 week pregnant patient with 8 hours of R lower quadrant pain. She has been nauseated for 8 wks.
Abdomen only mildly tender RLQ to deep palpation
WBC 16
US abdomen
CT scan
Exploratory laparoscopy
Possible options:

24. 2. Useful 1st line diagnostic study for many non-gyn causes
Ultrasound Guideline 1: Ultrasonographic imaging during pregnancy is safe and useful in identifying the etiology of acute abdominal pain in the pregnant patient (Level II, Grade A).
Guideline 1: Ultrasonographic imaging during pregnancy is safe and useful in identifying the etiology of acute abdominal pain in the pregnant patient (Level II, Grade A).
Abdominal pain in the pregnant patient can be separated into gynecologic and non-gynecologic causes. When radiographic studies are needed ultrasound is widely considered safe for the mother and fetus with relatively high sensitivity and specificity for many intra-abdominal processes. No maternal or fetal adverse effects have been reported. It is the radiographic test of choice for most gynecologic causes of abdominal pain including adnexal mass, torsion, placental abruption, placenta previa, uterine rupture and fetal demise. Ultrasound is also useful as a first line diagnostic study for many non-gynecologic causes of abdominal pain, allowing the practitioner to potentially avoid the need for ionizing radiation exposure [5-11].
1. Radiographic test of choice for most gynecologic causes of abdominal pain
2. Useful 1st line diagnostic study for many non-gyn causes

25. Risk of Ionizing Radiation Guideline 2: Expeditious and accurate diagnosis should take precedence over concerns for ionizing radiation. Radiation dosage should be limited to 5-10 rads in the first 25 weeks of pregnancy (Level III, Grade B).
* Radiation dosage
< 5 rads minimal fetal risk
Guideline 2: Expeditious and accurate diagnosis should take precedence over concerns for ionizing radiation. Radiation dosage should be limited to 5-10 rads in the first 25 weeks of pregnancy (Level III, Grade B).
Significant radiation exposure may lead to chromosomal mutations, neurologic abnormalities, mental retardation, and increase the risk of childhood leukemia. Radiation dosage is the most important risk factor but fetal age at exposure is also important [7, 8, 12]. Radiological exposure is measured using units of either rad or centiGrey (1 rad = 1 cGy). Fetal mortality is greatest when exposure occurs within the first week of conception prior to oocyte implantation. It has been recommended that the cumulative radiation dose from the first week of conception through week 25 be less than 5-10 rads [13]. The most sensitive time period for CNS teratogenesis is between 10 and 17 weeks gestation and non-urgent x-rays should be avoided during this time. In later pregnancy the concern shifts from teratogenesis to increasing the risk of childhood hematologic cancer. The background incidence of childhood cancer and leukemia is approximately %. Radiation may increase that incidence by 0.06% per 1 rad delivered to the fetus [13]. Exposure of the fetus to 0.5 rad increases the risk of spontaneous abortion, major malformations, mental retardation, and childhood malignancy to one additional case in 6,000 above baseline risk. It has been suggested that fetal risk is negligible at 5 rads or less and that the risk of malformation is significantly increased at doses above 15 rads. The accepted cumulative dose of ionizing radiation during pregnancy is 5-10 rads with no single diagnostic study exceeding 5 rads [8, 12-17].
* Fetal age at exposure
1st week of conception - mortality
10-17 weeks gestation – CNS teratogenesis
Later pregnancy – hematologic cancer

26. Fetal Radiation Exposure from Diagnostic Imaging Studies
Study
Rads
Chest radiograph <0.001
Abdominal series
Pelvic radiograph
Upper gastrointestinal series
Barium enema
HIDA scan
Chest CT scan
Abdominal CT scan
Pelvic CT scan
Rollins MD, Price RR. Laparoscopic surgery during pregnancy. In: Inderbir SG ed. Textbook of laparoscopic urology. New York: Informa Healthcare USA, Inc., 2006:

27. Computed Tomography Guideline 3: Contemporary multi-detector CT protocols deliver a radiation dose to the fetus below detrimental levels and may be considered as an appropriate test during pregnancy depending on the clinical situation (Level III, Grade B).
Early identification
Rate of perforation
Guideline 3: Contemporary multi-detector CT protocols deliver a radiation dose to the fetus below detrimental levels and may be considered as an appropriate test during pregnancy depending on the clinical situation (Level III, Grade B).
Computed tomography (CT) has a well-established role as a diagnostic modality in the non-pregnant patient. Many of the same non-obstetric indications for its use can also be found in a woman during pregnancy [18]. Employment of the CT scan should be weighed against the cumulative radiation exposure to the fetus. As a single test radiation exposure to the fetus is highest when a full scan of the abdomen and pelvis is obtained, reaching exposure levels up to 2-4 rads for a single study [7, 19, 20], which falls below the maximum recommended dose of 5 rads for a single study. Advancements in CT technology and protocols have led to decreased radiation doses. These levels vary by institution and the practitioner should be aware of the potential radiation exposure.
Practitioners should be aware of the radiation doses delivered by the CT scanners in their facilities.
CT abdomen and pelvis
2-4 rads

28. Laparoscopic Appendectomy Guideline 17: Laparoscopic appendectomy may be performed safely in any patients with suspicion of appendicitis (Level II, Grade B).
Laparoscopic appendectomy has become increasingly utilized in the gravid patient since its introduction and is considered by many to be the standard of care [49, 51, ]. Diagnosis of appendicitis is thought to be complicated by the anatomic changes and leukocytosis associated with pregnancy [ ]. A recent article, however, has shown that the majority (> 83%) of gravid patients with acute appendicitis present with classic right lower quadrant pain [120]. Negative appendectomy rates in the gravid patient have been reported as high as 22% to 55% [32, 69]. These high negative appendectomy rates may be due to the surgeon’s propensity to prevent perforation and avoid unnecessary morbidity and mortality.
When the diagnosis of appendicitis by ultrasound is equivocal, promptly proceeding to diagnostic laparoscopy or CT scan may allow for early identification and intervention in appendicitis decreasing the rate of perforation. 25% of all pregnant women who have acute appendicits will develop perforated appendicitis [121, 122]. A 66 % perforation incidence has been reported when surgery is delayed by more than 24 hours compared to 0% incidence when surgical management is initiated prior to 24 hours of presentation [123]. Of note, perforation of the appendix occurs twice as often in the third trimester (69%) compared to the first and second trimesters [124].

29. Conclusions
Guidelines are a moving process and when published they are a point in time rather than a completed process
Guidelines are much more difficult than most people realize
Guidelines should give the references for the conclusions the rating of the references and grading of the recommendations