The advantages of endoscopic surgery include an improvement in postoperative recovery, a shorter hospital stay and more rapid recovery. Disadvantages include a longer operative time, particularly if the surgeon is early in the learning curve.
Thermal Capsulorrhaphy A search of MEDLINE was performed for the period of January 2006 through October 2007. A Canadian workgroup reported a multicenter randomized controlled trial that has been recruiting subjects since 1999. Enrollment has been slower than anticipated; 19 patients treated with thermal capsulorrhaphy and 15 subjects treated with surgical repair have completed two-year follow-up. Two to six year follow-up was reported on 85 of 100 consecutive patients treated with thermal capsulorrhaphy for glenohumeral instability. Thirty-seven patients (43.5%) were considered to have had a failed procedure, defined as recurrent instability, revision of surgery, and recalcitrant pain or stiffness requiring manipulation. The authors concluded that this compares unfavorably with the reported 7.5% failure rate when thermal capsulorrhaphy is used to supplement suture plication, and they now generally use it only in combination with other surgical procedures. No studies were identified that assessed whether thermal capsulorrhaphy improves outcomes when combined with other arthroscopic procedures.
Laparoscopic radical hysterectomy is a technically challenging procedure. Published literature consists of primarily small case series. A literature search performed for the period 2003 through 2006 identified one comparative study. Steed and colleagues reported the results of the largest case series of 71 patients with stage 1A/1B cervical cancer who underwent laparoscopically assisted radical vaginal hysterectomy performed by the same surgeon. The outcomes of these patients were compared with 205 patients undergoing an abdominal radical hysterectomy. The laparoscopic procedure consisted of laparoscopic evaluation of the abdomen with lymph node dissection, further laparoscopic dissection of the parametrial tissues, with the procedure performed vaginally. Patients undergoing the laparoscopic approach experienced less operative blood loss, shorter hospital stays, but longer operative times, increased intra-operative complications, and increased time to normal urinary function. It is unclear from the published data whether any advantage to laparoscopic radical hysterectomy will be apparent in larger trials.
Transanal endoscopic microsurgery (TEMS) Despite many years of experience using this device in Europe, comparative data are very limited. Middleton authored a systematic review of this procedure in 2005 based on published results through August 2002. Three comparative studies, including one randomized controlled trial, and 55 case series were included. The authors concluded that the evidence regarding transanal endoscopic microsurgery is very limited, being largely based on a single relatively small randomized, controlled trial. A MEDLINE search through December 2007 did not identify any additional large comparative studies of this technique. Reports involved only small numbers of patients and/or involved case series. For example, a European study reported comparable results between TEMS and laparoscopic resection (both with adjuvant radiochemotherapy) for 40 patients with T2 rectal cancer. However, results from this small series must be interpreted with caution. Additional details are also needed about complications from this procedure. As noted in an article by Cataldo, complications are rare but can be significant. This article notes that major complication rates around 5% are reported in some series; these complications include intraperitoneal sepsis, rectovaginal fistulae, and postoperative hemorrhage requiring reoperation. Overall, given the lack of comparative data, this technique is considered investigational.
Myolysis of Uterine Fibroids In 2002, the American College of Obstetricians and Gynecologists (ACOG) published a review on the management of uterine fibroids, which was performed as an Evidence-based Practice Center report for the Agency for Healthcare Research and Quality (AHRQ). Ultimately the authors sought to use this review to form the basis of guidelines regarding the role of various treatment options, including hysterectomy, myomectomy, and uterine artery embolization. While this review did not directly report on techniques of myolysis, the report did comment on the quality of literature in general regarding the treatment of uterine fibroids. Specifically:
- There is almost no high-quality evidence on which to base treatment strategies.
- There are no randomized trials to support the superiority of one treatment over the other, including established treatments such as myomectomy or newer procedures such as uterine artery embolization.
- Inconsistency in reporting severity of symptoms, uterine anatomy, and response to therapy prevented comparisons between studies and prevented the performance of a meta-analysis.
- Efforts to standardize treatment or determine the most “appropriate” management, such as expert panel recommendations, clinical pathways, or use of review criteria are presumably based on the same literature reviewed. It is unclear how management strategies based on these efforts can be more “evidence-based” than individual patient or clinical opinion when the evidence is not interpretable.
- Rectifying the limitations in the reported literature should be a major research priority.
The published literature regarding techniques of myolysis is limited and of similar poor quality, even though some techniques, such as Nd:YAG laser myolysis have been available since the early 1990s. There are no controlled trials comparing myolysis to either hysterectomy or myomectomy, and the available case series often lack pertinent information such as uterine size, number and size of fibroids, location of fibroids (i.e., either subserosal, intramural, or submucosal), and recurrence rates. These factors relate to the technical feasibility of the procedure and patient selection criteria. Reporting of patient outcomes is inconsistent or absent. Therefore, data are inadequate to permit scientific conclusions regarding various laparoscopic or percutaneous myolysis techniques.
A search of the MEDLINE database through September 2009 found Good et al. conducted a retrospective chart review in 2007 on patients who had been referred for shoulder stiffness and had developed glenohumeral chondrolysis. Of the eight patients who had developed glenohumeral chondrolysis after shoulder arthroscopy, five had undergone thermal capsulorrhaphy for shoulder instability, and three had a thermal procedure with labral repair or synovectomy. The onset was described as early and rapid, with repeat arthroscopy to confirm the diagnosis of chondrolysis and rule out infection at an average of eight months after the initial shoulder arthroscopy. The mean age of the patients was 23 years (range, 15–39). None of the patients had evidence of chondral damage at the index arthroscopy, and none had received postoperative intra-articular pain pumps, a procedure which has also been associated with chondrolysis. The patients required between one and six procedures after the onset of chondrolysis to manage their pain, including glenoid allograft, humeral head arthroplasty, and total shoulder arthroplasty. Good and colleagues identified 10 additional reported cases of glenohumeral chondrolysis following shoulder arthroscopy in the English-language literature. Five of the 10 cases occurred after the use of gentian violet dye injection into the joint to identify a rotator cuff tear; this technique has since been abandoned. Of the remaining five reported cases, four involved the use of a thermal device during the procedure. An accompanying editorial by the journal’s editors concluded that “pending evidence to the contrary, shoulder thermal capsulorrhaphy is a procedure in which these and other reported risks outweigh any potential benefits.”
A search of the MEDLINE database through September 2009 found two comparative studies of transanal endoscopic microsurgery (TEMS). Lezoche and colleagues randomized 70 patients with T(2) N(0), G(1-2) rectal cancer to TEMS or laparoscopic resection via total mesorectal excision. All patients received chemoradiation prior to surgery. Median follow-up was 84 months (range: 72–96 months). Two local recurrences (5.7%) were observed after TEMS and one (2.8%) after laparoscopic resection. Distant metastases occurred in one patient in each group. The probability of survival for rectal cancer was 94% for TEMS and 94% for laparoscopic resection.
Moore et al. reported on a retrospective review of patients who underwent transanal excision for rectal neoplasms and compared results for traditional transanal resection and TEMS. Of 296 patients identified, 76 were excluded because surgery was for abscess, fistulas, inflammatory bowel disease, or multiple lesions. Forty-nine patients were excluded because of incomplete or missing charts. Records of 171 patients were analyzed; 82 patients who underwent TEMS and 89 who had transanal resection were analyzed. For patients who received TEMS, those with T1 lesions without adverse histologic features (poor differentiation or lymphovascular invasion) received local excision alone. Patients with T1 lesions with adverse features or T2 lesions received postoperative chemoradiation. Local excision was performed for T3 lesions only in high-risk patients or those who refused radical resection. In the TEMS group there were 40 polyps, five carcinoma in situ, 21 T1, 7 T2, 8 T3, 0 indeterminate, and one carcinoid, and in the transanal resection group: 38 polyps, four carcinoma in situ, 20 T1, 19 T2, 6 T3, same indeterminate, and one carcinoid. All patients treated before December 2001 received transanal resection (seven surgeons), TEMS was performed by one surgeon. Since the introduction of TEMS, 20 transanal resections were performed. There were 12 (15%) postoperative complications (four major) in the TEMS group and 15 (17%) complications in the transanal resection group (six major). In the TEMS group, 90% had negative tumor margins and none had indeterminate margins versus 71% negative and 15% indeterminate in the transanal resection patients. There were four recurrences in the TEMS group and 24 in the transanal resection group. Local recurrence was less frequent after TEMS versus transanal resection (4% vs. 24%, respectively, p=0.004). The difference between groups in distant recurrence was not significant. Three TEMS patients with malignant lesions underwent radical resection and were excluded from recurrence analyses. The recurrence rate among cancer patients was not statistically different between groups. For patients with adenomas, the overall recurrence rate after TEMS was 3% versus 32% for transanal resection. In patients with polyps, clear margins were achieved more frequently after TEMS (83%) than after transanal resection (61%).
Doornebosch and colleagues, in a systematic review, discuss weaknesses in the available evidence, and still unanswered questions about the role of TEMS. They pose three questions: “First, is there enough evidence to propagate LE [local excision] as a curative option in selected (T1) rectal carcinomas? Second, if LE is justified, which technique should be the method of choice? Third, can we adequately identify, pre-and postoperatively, tumors suitable for LE?” They note that selection bias in studies complicates answering the first question; and a significant portion of tumors recurred in all studies using various techniques for local excision (including TEMS), although it seemed not to influence survival rates. The authors note that the published case series reporting outcomes after TEMS for T1 rectal carcinomas utilized inclusion criteria that were not always clear and use of salvage procedures may introduce bias. TEMS was demonstrated to be a safe procedure in all series; complications rates vary between 5% and 26%, and complications were generally minor. Local recurrence rates for TEMS varied between 4% and 33% in the studies reviewed. Regarding the third question, the authors wonder if high recurrence rates could be improved by better tumor selection. The authors note that TEMS has been incorporated into surgical practice based largely on retrospective case series. They also note that despite the lack of level I evidence, its use seems justified in well-selected T1 rectal cancers. Some might view TEMS as an alternative for those with T1 lesions who are currently undergoing other methods of local excision such as local excision according to the Parks technique, instead of radical surgery, for their T1 lesions.
The National Comprehensive Cancer Network (NCCN) guideline on treatment of rectal cancer states that, when criteria for transanal resection are met, transanal endoscopic microsurgery can be used when the tumor can be adequately identified in the rectum. The guideline is based on level 2A evidence for T1 tumors and level 2B evidence for T2 tumors.
In summary, based on review of the published data, there is sufficient evidence to conclude that transanal endoscopic microsurgery (TEMS) is a safe and effective (low recurrence rates) procedure for excision of rectal adenomas that cannot be removed by traditional local approaches such as endoscopic removal. Similarly, based on review of the literature and clinical input, use of TEMS may be considered medically necessary in selected, low-risk T1 rectal cancers. These clinical-stage T1 cancers are those that are located in the middle or upper part of the rectum, are well or moderately differentiated (G1 or G2) by biopsy, there is no lymphadenopathy, and less than one-third of the circumference of the rectum is involved. Thus, these applications may be considered medically necessary.
The data on use of TEMS in other rectal cancers are much more limited. There are still important questions about selection of other cancers for local excision. Thus, use of TEMS for rectal cancers that do not meet the criteria noted above, including T2 lesions, is considered experimental, investigational and unproven because the impact on net health outcome is uncertain.
Myolysis of Uterine Fibroids
A search of the MEDLINE database through September 2009 identified two feasibility and safety studies using percutaneous sonographically guided radiofrequency ablation for medium-sized and large symptomatic uterine leiomyomas (fibroids) after uterine artery embolization. The authors concluded that percutaneous sonographically guided radiofrequency ablation alone is a feasible and efficient procedure in the management of medium-sized uterine myomas, and as adjunctive therapy to uterine artery embolization under moderate sedation, appears safe without significant morbidity in the treatment of large uterine leiomyomas. However, these results are to be considered preliminary. Further studies are needed to assess the efficacy and potential benefit of percutaneous radiofrequency ablation as a primary or an adjunctive treatment to uterine artery embolization for symptomatic leiomyoma.
In August 2008, the American College of Obstetricians and Gynecologists issued a Practice Bulletin titled “Alternatives to Hysterectomy in the Management of Leiomyomas” which replaces Practice Bulletin Number 16, May 2000, and Committee Opinion Number 293, February 2004. This Bulletin contains no recommendations regarding myolysis utilizing laparoscopic or percutaneous techniques.
In summary, the current data are inadequate to permit scientific conclusions regarding various laparoscopic or percutaneous myolysis techniques. The issues identified with the 2007 update remain; those are a need to have well-designed, long-term, randomized controlled trials with larger patient populations to provide evidence for long-term (durable) clinical outcomes and to establish the appropriate patient selection criteria. The policy statement is unchanged and remains experimental, investigational and unproven due to insufficient evidence to evaluate the impact on health outcomes.
A search of peer-reviewed literature was performed through November 2010. Although controlled trials are lacking regarding occlusion of persistent bronchopleural fistula via bronchoscopy, the evidence thus far in case reports suggest its efficacy in selected patients not eligible for surgery. Various endoscopic options are successful in 35% to 80% of cases and have been responsible for significantly reducing the morbidity and mortality from bronchopleural fistulae.
A search of peer-reviewed literature was performed through April 2013. Following is a summary of the key literature to date.
Robotic Assisted Surgery
Wright and colleagues analyzed complications, transfusion, reoperation, length of stay, death and cost for women who underwent robotic hysterectomy compared with both abdominal and laparoscopic procedures, in a cohort study of 264,758 women who had a hysterectomy performed for benign gynecologic conditions at 441 hospitals in the United States from 2007 to 2010. The results noted included use of robotically assisted hysterectomy increased from 0.5% in 2007 to 9.5% of all hysterectomies in 2010. Three years after the first robotic procedure at hospitals where robotically assisted hysterectomy was performed, robotically assisted hysterectomy accounted for 22.4% of all hysterectomies. The authors also noted the following results: In a propensity score-matched analysis, overall complication rates were similar for robotic-assisted and laparoscopic hysterectomy (5.5% vs 5.3%; relative risk [RR], 1.03; 95% CI, 0.86-1.24). Although patients who underwent a robotic-assisted hysterectomy were less likely to have a length of stay longer than 2 days (19.6% vs 24.9%; RR, 0.78, 95% CI, 0.67-0.92), transfusion requirements (1.4% vs 1.8%; RR, 0.80; 95% CI, 0.55-1.16) and the rate of discharge to a nursing facility (0.2% vs 0.3%; RR, 0.79; 95% CI, 0.35-1.76) were similar. The authors also note in their conclusions that robotically assisted and laparoscopic hysterectomy has similar morbidity profiles, but the use of robotic technology resulted in substantially more costs (63).
Magheli A et al. examined the pathological and biochemical outcomes of patients who underwent robot-assisted radical prostatectomy (RARP), laparoscopic radical prostatectomy (LRP), and radical retropubic prostatectomy (RRP). Between 2003 and 2008, five hundred twenty-two consecutive patients who underwent RARP were matched by propensity scoring on the basis of patient age, race, biopsy Gleason score, preoperative prostate-specific antigen, and clinical stage with an equal number of patients who underwent LRP and RRP at a single institution. The authors reported the following in their results; overall positive surgical margin rates were lower among patients who underwent RRP (14.4%) and LRP (13.0%) compared to patients who underwent RARP (19.5%) (P= 0.010). There were no statistically significant differences in positive margin rates between the three surgical techniques for pT2 disease (P= 0.264). Kaplan-Meier analysis did not show any statistically significant differences with respect to biochemical recurrence for the three surgical groups. Conclusions noted by the authors included the following; RRP, LRP and RARP represent effective surgical approaches for the treatment for clinically localized prostate cancer. A higher overall positive SM rate was observed for the RARP group compared to RRP and LRP; however, there was no difference with respect to biochemical recurrence-free survival between groups. The authors also noted that further prospective studies are warranted to determine whether any particular technique is superior with regard to long-term clinical outcomes (64).
The Society of Gynecologic Oncology has developed a consensus statement document regarding robotic-assisted surgery in gynecologic oncology. The document addresses several considerations regarding robotic surgery, including clinical impact, training impact, and quality of life. The authors noted “The need for randomized controlled trials to compare outcomes of robotic technology to other forms of minimally invasive surgery is a topic of debate. Robotics simply represents a new tool to accomplish a minimally invasive procedure. As with other tools for minimally invasive surgery, their broad-based use has been largely incorporated into standard surgical practice based on retrospective analysis and surgeon preference.” The authors’ concluded that current evidence supports equivalence of robotic surgery and laparoscopy in many perioperative outcome measures (65).
The literature does not support that robotic technology is superior to minimally invasive surgical approaches. It is a tool for minimally invasive surgery, subject to the surgeon’s preference, therefore, robotic assistance as an adjunct to the primary procedure is considered not medically necessary
A 2010 review of shoulder instability in patients with joint hyperlaxity indicates that although initial results with thermal capsulorrhaphy seemed promising, subsequent studies with longer follow-up showed “unacceptably high rates of failure and postoperative complications”, including cases of postoperative axillary nerve palsy and transient deltoid weakness. (66) Abnormal capsular tissue has also been observed in the areas of previous thermal treatment, with either severe thickening or thin, friable deficient capsule. In a 2011 review, Virk and Kocher describe thermal capsulorrhaphy as a failed new technology in sports medicine. (67)
Case Series: D’Alessandro and colleagues published the results of a prospective study of 84 patients who underwent thermal capsulorrhaphy for various indications in 2004. (14) With an average follow-up of 38 months, 37% of patients reported unsatisfactory results, based on reports of pain, instability, return to work, and the American Shoulder and Elbow Surgeons Shoulder Assessment score. The authors reported that the high rate of unsatisfactory results was of great concern. Levine and colleagues reported that the initial wave of enthusiasm for thermal capsulorrhaphy has largely subsided, given the negative results reported by D’Alessandro et al. (16)
The literature does not support use of thermal capsulorrhaphy. The few available comparative studies do not support that this procedure is an efficacious treatment for instability. The case series report a high rate of unsatisfactory results and complications, raising the potential for a net harm. Because of the lack of efficacy and potential for harm, this procedure is experimental, investigational and unproven.
In 2011, Wu and colleagues published a meta-analysis on TEMS and conventional surgery for T1 rectal cancers. (68) Five studies were included in the analysis including 1 prospective random controlled trial and 4 retrospective, nonrandomized studies for a total of 397 (216 TEMS and 181 conventional rectal surgery) patients. Combined analyses were performed for mortality, postoperative complications, recurrence rate, and 5-year survival. No deaths were reported from either procedure, and TEMS resulted in fewer postoperative complications than conventional surgery (16/196 vs. 77/163). On combined analysis the odds ratio (OR) for complications was 0.10 (95% CI: 0.05 to 0.18). There was a higher rate of local recurrence or distant metastasis at 40-month follow-up for the TEMS group versus conventional radical surgery (CRS, 12% [26 of 216] vs. 0.5% [1 of 181]). On the combined analysis the odds ratio for recurrence in the CRS group was 8.64 (95% CI: 2.63 to 28.39). The 5-year survival (not specified as disease-specific or overall), as reported in 4 studies, was not significantly different between groups at 80.1% (157 of 196) in TEMS patients and 81% (132 of 163) in conventional surgery patients. These results support the conclusion that TEMS is associated with less early complications but a higher rate of recurrence compared to standard resection, with no demonstrable differences in overall survival.
Sgourakis et al., in 2011, conducted a meta-analysis of T1 and T2 rectal cancer treatment with TEMS compared to standard resection and transanal excision (TAE). (69) Eleven studies were included in the analysis and included 3 randomized controlled, one prospective, and 7 retrospective studies for a total of 1,191 (514 TEMS, 291 standard resection, and 386 TAE) patients. Numerous combined analyses were performed for measures of mortality, complications, and recurrence rates. For postoperative complication rates, combined analysis showed a significantly lower rate of major complications for TEMS versus standard resection (OR: 0.24, 95% CI: 0.07-0.91). Minor complications were not significantly different between these groups. Overall postoperative complications were not significantly different between TEM versus TAE when T1 and T2 tumor data were pooled. Follow-up for all of the studies was a mean/median of more than 30 months (except for follow-up of more than 20 months in one treatment arm in 2 studies). For T1 tumors, local recurrence was significantly higher for the TEMS versus the standard resection group (OR: 4.92, 95% CI: 1.81-13.41), as was overall recurrence (OR: 2.03, 95% CI: 1.15-3.57). Distant metastasis (OR: 1.05, 95% CI: 0.47-2.39) and overall survival (OR: 1.14, 95% CI: 0.55-2.34) were not significantly different between groups. Results were similar when data were analyzed with T1 and T2 tumors, except that disease-free survival was significantly greater with TEMS versus TAE. There was less evidence available for T2 tumors, and conclusions for that group of patients were less clear. The results of this review also support the conclusions that TEMS is associated with less postoperative complications compared with standard resection, a higher local and distant recurrence rate, and no difference in long-term overall survival.
In 2012, E. Lezoche et al. published an additional report of a similar random controlled trial of 100 patients with T2 rectal cancers without evidence of lymph node or distant metastasis randomized to receive either TEMS or laparoscopic total mesorectal excision. (62) All patients received neoadjuvant chemoradiation prior to surgery. All patients in the TEMS group were able to complete the procedure. However, with laparoscopic resection, 5 patients (10%) required conversion to open surgery (p=0.028), and 23 patients required a stoma. Postoperative complications were not significantly different between groups. Disease-free survival was also not significantly different between groups (p=0.686) after a median follow-up of 9.6 years (range 4.7-12.3 years for the laparoscopic resection group and 5.5-12.4 for the TEMS group). Local recurrence or metastases occurred in 6 TEMS patients and 5 laparoscopic patients. Overlap of patients from the 2008 and 2012 studies cannot be determined.
Practice Guidelines and Position Statements
The American Society of Colon and Rectal Surgeons has published practice parameters for the management of rectal cancer. (70) They state that curative local excision is an appropriate treatment modality for carefully selected T1 rectal cancer. Transanal endoscopic microsurgery uses similar surgical principles as a transanal local excision but is designed to remove lesions up to approximately 20 cm from the anal verge. Both transanal local excision and transanal endoscopic microsurgery may afford reasonable palliation for patients with metastatic disease who are poor candidates for a more extensive surgical procedure.
The American College of Radiology (ACR) has issued appropriateness criteria on local excision of early-stage rectal cancer. (71) The ACR notes TEMS is an appropriate operative procedure for locally complete excision of distal rectal lesions and has been “evaluated for curative treatment of invasive cancer.” TEMS is noted to have “been shown to be as effective, and possibly better than, conventional transanal excision” and is considered safe after treatment with chemoradiation. These ACR guidelines are based on expert consensus and analysis of current literature.
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