Journal of Minimally Invasive Gynecology (2007) 14, 339 –344
Major complications arising from 1265 operative laparoscopic cases: A prospective review from a single center Keith Johnston, MRCOG, David Rosen, FRANZCOG, Gregory Cario, FRANZCOG, Danny Chou, FRANZCOG, Mark Carlton, FRANZCOG, Michael Cooper, FRANZCOG, and Geoffery Reid, FRANZCOG From Sydney Women’s Endosurgery Centre (SWEC), St. George Private Hospital, Kogarah, New South Wales, Sydney, Australia (all authors). KEYWORDS: Operative laparoscopy; Complications
Abstract STUDY OBJECTIVE: To identify the volume and type of laparoscopic surgery being performed. To review the incidence, nature of associated complications, and reasons for conversion to laparotomy. DESIGN: A multicenter, prospective case load analysis and chart review, identifying operations performed by 6 advanced laparoscopic surgeons over a 12-month period (1/1/05 to 12/31/05). SETTING: Surgical cases were performed in 5 hospitals in Sydney, New South Wales. PATIENTS: One thousand two hundred sixty-five women underwent a variety of major and advanced operative procedures. MEASUREMENTS AND MAIN RESULTS: A total of 1265 major and advanced laparoscopic procedures were performed. Laparoscopic hysterectomy accounted for 364 cases (28.8%), pelvic floor repair and Burch colposuspension 280 cases (22.2%), excisional endometriosis surgery 354 cases (28%), adnexal surgery 177 cases (13.9%), adhesiolysis 75 cases (5.9%), and miscellaneous cases 15 (1.2%). Overall major complications in terms of bowel, urologic, or major vessel injuries accounted for 8 cases (0.6%). There were 4 injuries of the bowel, 2 injuries to the bladder, and 2 injuries to ureters. There were no major vessel injuries. There were no injuries associated with primary trocar or Veres needle insertion. The most common perioperative morbidity reported was the requirement for blood transfusion (11 cases [0.9%]), and the second most common was venous thromboembolism (4 patients [0.3%]). Six (0.5%) cases were converted to laparotomy, 2 as a result of a complication and 4 for technical reasons. Six of the 8 complications were managed laparoscopically, and a multidisciplinary input was sought only in 4 of the 8 complications. CONCLUSIONS: Despite the advanced nature of laparoscopic procedures performed by our group, the complication rate and conversion to laparotomy remain low. There is an increasing feasibility to perform traditional open operations laparoscopically. An increasing number of these complications are now being managed laparoscopically by the gynecologist. © 2007 AAGL. All rights reserved.
The authors have no commercial, proprietary, or financial interest in the products or companies described in this article. Corresponding author: Keith Johnston, MRCOG, Sydney Women’s Endosurgery Centre, St. George Private Hospital, 1 South Street, Kogarah, New South Wales, Sydney, Australia. E-mail:
[email protected] Submitted July 24, 2006. Accepted for publication December 4, 2006.
1553-4650/$ -see front matter © 2007 AAGL. All rights reserved. doi:10.1016/j.jmig.2006.12.003
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Laparoscopic surgery in general, and gynecologic laparoscopy in particular, has become an accepted and in many cases standard option for the surgical management of many conditions. Cholecystectomy or removal of ectopic pregnancies, for example, is now routinely performed via the minimally invasive route in many parts of the world. As technology has progressed and surgical skills advanced, the nature and complexity of procedures able to be performed laparoscopically has grown. In centers of advanced laparoscopy, management of complex adnexal lesions, hysterectomy, pelvic floor repair, resection of high-grade endometriosis, colposuspension, sacrospinous colpopexy, and many varied other procedures are preferentially managed via this route. Although it is widely acknowledged that laparoscopy conveys significant advantages to the patient in terms of faster recovery and return to normal activity, shorter inpatient stay, and lower levels of postoperative discomfort,1–5 there remains a pall of uncertainty regarding an unacceptably high rate of complications.6,7 It is our belief that in centers of advanced laparoscopy, complicated procedures can be performed with an acceptably low rate of complications. This article reports on 12 months of advanced and major gynecologic laparoscopic cases in 1 center among 6 specialist laparoscopic surgeons.
Methods The definition of major is taken from Harkki-Siren and Kirken.8 Major complications involved damage to viscera (bowel/bladder/ureter) or vasculature (including major hemorrhage). One thousand two hundred sixty-five laparoscopies were performed from January 1 through December 31, 2005, by 6 gynecologic laparoscopic surgeons with experience in major laparoscopic surgery ranging from 8 to 16 years. Data were collected prospectively from all operative gynecologic procedures and classified according to the definition established by the classification of Chapron et al9 (Table 1). Most cases involve level 3 (ectopic pregnancy, ovarian cysts, endometriosis) and level 4 (total laparoscopic hysterectomy, myomectomy, incontinence and prolapse surgery) procedures (Tables 1 and 2).
Table 2
Case load analysis
Operation description
No.
% of total operations
Laparoscopic pelvic floor repair Laparoscopic hysterectomy* Laparoscopic Burch colposuspension Excisional endometriosis surgery Adnexal surgery Adhesiolysis Other
364 161 119 354 117 75 15
28.8 12.7 9.5 28 13.9 5.9 1.2
*Two hundred ninety-five total laparoscopic hysterectomies and 69 laparoscopic-assisted vaginal hysterectomies.
All major surgery was performed with the patient under general anesthesia after preoperative bowel preparation (Pico-prep; Pharmatel Fresenius Kabi Pty Ltd, New South Wales, Australia). Patients had the urinary bladder catheterized and were placed in the Trendelenburg position after primary entry. Four primary entry techniques were used (Table 3), with appropriate and recommended safety measures used.10 The entry techniques used were according to surgeon preference. Palmer’s point entries were used when there was documentation of difficult adhesions present at a previous abdominal or pelvic surgery or in the presence of a large previous midline scar. High entry pressures of between 20 to 25 mm Hg are used to maintain a large distance between anterior abdominal wall and the underlying viscera and vessels. Skin incisions for trocar entry were of adequate size for the proposed trocar to avoid undue downward pressure to overcome skin resistance during insertion. Secondary trocars were all introduced under direct vision. We used reusable trocars guarding entry with an index finger. Entry was perpendicular to the abdominal wall, and when the parietal peritoneum was tented by the tip of the trocar, we changed to a more horizontal axis of entry before breaching the peritoneum to maintain a safer distance from underlying viscera or major vessels. When adhesions were present, adhesiolysis to restore normal anatomy and to allow safe secondary trocar entry was always carried out before commencing the planned surgical procedure. This was often facilitated by use of extra trocar sites in areas of the abdominal wall not involved with adhesions. The deep inferior epigastric vessels were always visualized before insertion of secondary ports. We also attempted to visualize and avoid more superficial abdominal vessels via transillumination
Table 1 Description of laparoscopic procedures according to Chapron et al9 No.
% of total operations
Table 3
Classification of laparoscopic procedure Group Group Group Group
0 115 496 654
0 9 39 52
Entry method
No.
% of total
Complications
Hasson Veres Direct Palmers
407 418 429 11
32.2 33 33.9 0.9
1 0 0 0
1 2 3 4
(diagnostic laparoscopy & TPT) (minor surgical procedures) (major surgical procedures) (advanced surgical procedures)
TPT ⫽ tubal patency test.
Laparoscopic entry techniques
Johnston et al Table 4
Major complications arising from operative laparoscopy
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Patient demographics: age, BMI, and parity are expressed as range and mean (95% CI)
Age BMI Parity Previous midline scar/s Previous transverse abdominal scar/s
Range
Mean
No. of patients
% of total patients
15 to 72 18 to 40 0 to 5 — —
43 (42.34–43.66) 28 (27.7–28.3) 2 (1.93–2.07) — —
1265 1265 1265 51 481
100 100 100 4 38
BMI ⫽ body mass index.
when body habitus allowed. To avoid the problem of incisional hernias at port sites, intraumbilical incisions were inspected carefully after removal of the primary trocar and either closed with 1 to 2 interrupted or a purse-string technique with 0 polyglactin suture material. The integrity of this rectus sheath closure was then checked with index finger palpation. When using 10-mm to 12-mm trocars in any other abdominal location, we used muscle-splitting trocars, which avoid the necessity for primary closure of the wound. Intraabdominal pressure was maintained between 12 to 15 mm Hg throughout the procedures.
Results One thousand two hundred sixty-five operations were performed over a 12-month period (Table 2). The demographics of our patients are summarized in Table 4. Ninetyone percent of the cases in this study were classified as advanced or major. The largest cohort of 654 patients (52%) was advanced operative laparoscopies. Laparoscopic hysterectomy was the most common procedure (364 patients) with 81% total laparoscopic hysterectomy (TLH) and 19% laparoscopic-assisted vaginal hysterectomy (LAVH). Laparoscopic excision of endometriosis (354 patients) accounted for the second most common operation performed. These
Table 5
patients were classified according to the revised-American Fertility Society system; mild to moderate in 110 women (31%) and severe in 254 (69%). Conversion to laparotomy occurred in 6 patients (0.5%). Four of these occurred because the surgeon deemed the operation too difficult laparoscopically. One of these was to achieve hemostasis during a laparoscopic myomectomy. Three laparoscopic hysterectomies were deemed technically too difficult because the patients had concurrent large myomatous uteri, severe endometriosis, and dense adhesions. One third of the laparotomies (2 patients) were performed to manage a complication. Entry techniques accounted for 1 of the 8 (12.5%) major complications. This occurred during a Hasson entry where a section of small bowel was picked up together with the rectus sheath and incised, in a very thin patient. This was recognized immediately and repaired. Overall 8 major complications are summarized in Table 5 accounting for 0.6% of the total operations. There were 4 intestinal injuries, 2 to the small and 2 to the large bowel. Four urologic injuries occurred, 2 to the bladder and 2 involving the ureter. There were no major deep pelvic vascular injuries. All four bowel injuries were recognized immediately during surgery. There were 2 injuries to the small bowel; 1 of these arose (noted above) during a Hasson entry on a very thin patient and 1, a burn injury
Summary of complications
Complications site
Operation
Recognition timing
Multidisciplinary input
Management approach
Possible associated factors
Small intestine Small Intestine
PFR* TLH
Immediate Immediate
General surgeon General surgeon
Laparotomy Laparotomy
Rectum Rectum
TLH & PFR Endometriosis excision
Immediate Immediate
None None
Laparoscopy Laparoscopy
Bladder Bladder Ureter Ureter
LAVH LAVH Endometriosis Endometriosis excision
Immediate Immediate Immediate Delayed
None None Urologist Urologist
Vaginally Laparoscopy Laparoscopy Cystoscopic
Very thin patient Use of 2 concurrent energy sources — Pouch of Douglas obliteration 3 previous caesareans — Severe disease excision Severe disease
LAVH ⫽ laparoscopic-assisted vaginal hysterectomy; PFR ⫽ pelvic floor reconstruction; TLH ⫽ total laparoscopic hysterectomy. *Laparoscopic pelvic floor reconstruction. This definition includes a retropubic laparoscopic paravaginal repair, posterior paravaginal repair (i.e., rectovaginal dissection to the levator plate with insertion of bridging support sutures), sacrocolpopexy, or a combination of these procedures. The above are often combined with uterosacral plication.
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with a harmonic scalpel when the 2 energy sources were used concurrently in the abdominal cavity. General surgeons were called to review the injuries in both of these cases and conversion to laparotomy to inspect the bowel was performed. The injuries were then repaired by the gynecologist with a simple interrupted suture. There were 2 injuries to the rectum; both of these again were recognized immediately. The first arose during dissection of the rectovaginal space during a laparoscopic posterior vaginal compartment reconstruction. The second occurred during resection of endometriosis off the rectum in a case of pouch of Douglas obliteration caused by severe endometriosis. In both cases of rectal injuries, a general surgeon’s opinion was not sought, and the defects were repaired by the gynecologist with an intracorporeal knottying technique. There were no adverse short- or longterm sequelae from either of the bowel injuries. There were 2 bladder injuries, both of which occurred during LAVHs. The first of these occurred during the vaginal part of the procedure and was oversewn by the gynecologist. The second case arose during the laparoscopic component of the LAVH in a woman who had 3 previous caesarean sections with very adherent bladder adhesion. This defect was repaired with a laparoscopic intracorporeal suture. A catheter was left in situ for 72 hours, and neither patient had any adverse sequelae from these injuries. There were 2 ureteric injuries; 1 of these occurred during excision of extensive pelvic side wall endometriosis. This injury was recognized immediately and confirmed after intravenous injection of indigo carmine. A urologist was called and a double-J stent was placed. The defect was then closed with a laparoscopic incorporeal suture. The stent was removed after 6 weeks. The result of an intravenous urethrogram was normal, and the patient made a good recovery. The second ureteric injury was not noted until 5 weeks after surgery. The patient presented with left loin pain, and a contrast study revealed a urinoma. A double-J stent was placed by the urologist and subsequently removed. This patient had no adverse long-term sequelae. The most common perioperative morbidity reported was the requirement for blood transfusion; this accounted for 11 cases (0.9%). The requirement for transfusion appears to be more common in complex procedures. Six of these significant hemorrhages occurred during total laparoscopic hysterectomies, 2 during laparoscopic-assisted vaginal hysterectomies, and 3 during laparoscopic myomectomies. The second most frequent reported significant morbidity was venous thromboembolism in 4 patients (0.3%). Six (0.5%) cases were converted to laparotomy, 2 as a result of a severe hemorrhages at laparoscopic myomectomy and 4 patients undergoing total laparoscopic hysterectomies were converted to an open approach because of severe adhesions, extensive endometriosis, and myomatous uteri. Six of the 8 complications were managed laparoscopically, and a multidisciplinary input was sought only in 4 of the 8 complications.
Discussion For any new surgical technique, especially one involving sophisticated equipment and instrumentation, it is appropriate that high levels of oversight are maintained. The new technique should first be as effective, if not more than, the surgical technique it aims to supersede, and equally it should be at least as safe. Advanced laparoscopic surgery has certainly been shown to be effective; however, it has suffered under criticism of an unacceptably high rate of complications. Large-scale randomized controlled trials, such as the eVALuate hysterectomy study11 demonstrate just this point—an effective technique with a higher rate of complications than the traditional forms of abdominal and vaginal hysterectomy. Is the new technique, in this case laparoscopic hysterectomy, inherently more dangerous, or are there variables at work that can account for these findings? We believe the latter. Significant factors in the rates of surgical complications are surgical experience, dedicated and enthusiastic support staff—the team approach, access to best available equipment, and the patient. At Sydney Women’s Endosurgery Centre, our dedicated surgical team includes 2 to 3 surgeons. The primary surgeon will operate with another consultant or laparoscopically trained fellow. The luxury of a third surgical assistant at the vaginal end is that this provides the appropriate traction and axis changes via a uterine manipulator or vaginal and rectal probe, thus optimizing the surgical field exposure for the primary surgeon. Our unit’s nursing staff are trained in laparoscopic surgical setup and are familiar with the various surgeon’s instrumentation and techniques. Our surgeons operate with the same regular theater sisters at every case. Theater and nursing staff experience and familiarity are not easy to quantify but do, however, create a more favorable, familiar, and relaxed environment in which to operate. In terms of technical advice for both instruments and laparoscopic stack troubleshooting, we have excellent on-site or a relatively rapid response from the various suppliers. Our close association with the allied colorectal and urologic surgical teams (often in adjacent theaters) within our hospital adds further to the safety of our approach. We feel it is vital to have dedicated surgical and theater staff for any major laparoscopic case. Not only does this expedite surgery, but it also minimizes complications, and we recommend this approach to other units embarking on advanced and major operative procedures. We use the Harmonic ACE scalpel (Ethicon; Endo-Surgery, Inc., Cincinnati, OH) for a large number of our hysterectomies and find this instrument fast and safe. Lateral spread of energy from this instrument is minimal, thus providing protection from collateral injury, and it also offers a good coagulation effect on vessels with a caliber of 5 mm and less. All surgeons are trained in the principles of traditional electrosurgery. Bipolar and monopolar energy sources are used precisely, under clear vision, and the spread of energy is observed. It is of course of utmost
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Major complications arising from operative laparoscopy
importance that there is good clearance of bowel, urologic structures, and major pelvic vessels from the surgical field before the scalpel’s activation. Injuries in laparoscopic surgery often occur when the surgeon’s view is obscured or the surgeon is not concentrating on the monitor. We firmly believe in the principle that “everything must be done under vision.” Although it is beyond the scope of this article to address all techniques to avoid visceral, urologic, and vascular injury, our surgeons find some of the following intraoperative principles useful. We clearly identify the major pelvic vessels, rectum, ureters, and bladder at the commencement of each case. Where necessary, restoration of normal anatomy via adhesiolysis is performed before embarking on the planned procedures. If the bladder is difficult to visualize, one can fill it retrogradely with saline solution. Instillation of a methylene blue and saline solution mixture is also useful to help isolate any full-thickness breeches in the bladder muscle when suspected. We perform releasing peritoneal incisions lateral to the ureters before isolating our infundibulopelvic pedicles at hysterectomy or adenectomy. Before uterosacral plication or posterior rectovaginal dissection, we fenestrate medial to the ureters, always to have these as reference points when difficult dissection or suturing is required. Often, complete pelvic retroperitoneal ureteric dissection is also used in case extensive endometriosis exists. All of our pelvic floor reconstructions, hysterectomies, difficult adnexal, or pelvic sidewall surgeries have cystoscopy performed after completion of surgery to check for ureteric patency. All of our operative patients have preoperative bowel preparation, the main rationale being this helps decompress the bowel, aiding clearance from the pelvis. In cases of severe endometriosis involving rectum or pouch of Douglas obliteration, the para-rectal spaces are dissected to mobilize the rectum and to help facilitate excision and resection, when deemed necessary. One can affect the outcome of any particular operation by optimizing patient preparation for surgery and selecting modes of surgery most appropriate to the individual patient. The other factors, however, can be altered on an individual basis. Reports of complications require large numbers of patients to present a meaningful numerator and, hence, routinely involve multicenter retrospective reports. This article highlights a large number of advanced cases from a single center with 8 to 16 years of laparoscopic surgical experience among the surgeons involved, and we believe this accounts for the low rate of complications reported. There is no doubt this low rate illustrates the fact that the learning curve has been surpassed, and there are those who would argue that this is not reflective of the surgical population as a whole. Reports of an increasing rate of complications with more complex surgery abound,12–16 and yet recent evidence suggest otherwise. Chapron et al17 report on a meta-analysis of 27 prospective randomized, controlled trials comparing 1809 women treated by laparoscopy with 1802 by laparotomy for benign gynecologic
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conditions. They found no greater rate of major or minor complications in the laparoscopic group. Results from a single center also highlight the advantages of a dedicated surgical team and operating theater environment. The ability of a hospital to offer the best possible environment for laparoscopic surgery has been shown to minimize complications and offer cost-effectiveness,18 whereas the benefits of skilled surgical assistance and scrub staff minimize complications and reduce operating time. The risks factors associated with laparoscopic surgery are well recognized; these include previous abdominal and pelvic operations, pelvic adhesions caused by endometriosis, previous and undetectable inflammation, both low and high body mass index, age over 35 years, and complexity of the procedure.16 Entry technique, creation of a pneumoperitoneum, and trocar insertion are responsible for a significant number of complications in laparoscopic surgery.12,13,16 In our series, there were 1256 primary trocar entries and only 1 major complication resulting from these. This equates to 0.8% incidence of primary; however, this setup phase of the surgery accounted for 1 of the 8 (12.5%) major complications. There were no injuries attributed to secondary trocar insertion. All of our secondary trocars are inserted under direct vision only after the inferior epigastric vessels have been identified. Appropriate importance and training should be dedicated to this aspect by surgeons. Endometriosis was the causative disease in which 3 cases presented. The infiltrative, often deeply invasive nature of this disease of course makes surgery much more difficult, and it could be argued that, in some cases for complete excision or removal of the disease, it is necessary to breech the wall of involved viscera. In only half of the complications presented here, the opinion of another surgical discipline was sought. In 2 cases involving rectal injury and 2 involving bladder injury, the gynecologist repaired these with intracorporeal laparoscopic sutures, and no adverse sequelae were reported. In today’s medicolegal climate, this management could easily have been called into question. Where an adverse outcome has resulted from an injury, particularly a gastrointestinal, urologic, or vascular injury, failure to seek a multidisciplinary input would probably have significant medicolegal ramifications. This article also highlights the ability to manage complications laparoscopically with fewer conversions to laparotomy, as also found in Chapron’s article; it could be speculated that that the 2 injuries of the small bowel could have also been repaired laparoscopically because both of these did not require resections, just a simple suture placement to the damaged bowel mucosa. The general surgeons who reviewed these were not particularly comfortable with laparoscopic suturing.
Conclusions Pierre et al18 state, “Laparoscopic surgery complication rate should be evaluated in an unselected population of
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operators.” We profoundly disagree. In the 21st century the buzz word is “best practice.” One could certainly make a case for only those surgeons with adequate training, fellowships, and certification and subsequent experience being permitted to operate laparoscopically. These laparoscopic surgeons should audit their case load and complications on a yearly basis. If a laparoscopic surgeon’s practice is substandard, a review by an appropriate laparoscopic committee or body should be undertaken. This, of course, relies on honest reporting of one’s practice and complications and also having peers/preceptors with enough time and expertise to supervise other laparoscopic surgeons in practice. This argument, on the other hand, could just as easily be used for any gynecologist undertaking any form of vaginal or abdominal surgery. If such an aim is relevant to automobile production or rice harvesting, surely in something as important as human surgery we should seek out those examples that provide outstanding results and aspire to those marks. All operators should look to centers of excellence to provide guidance for theater set-up, assembling a dedicated theater team and gaining vital surgical experience. In this way, we believe we have shown, rates of surgical complications can be drastically reduced to the benefit of ourselves and, most importantly, our patients.
4.
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