The Dexterity Pneumo Sleeve system.
Southern Surgeons' Club Study Group. Handoscopic SurgeryA Prospective Multicenter Trial of a Minimally Invasive Technique for Complex Abdominal Surgery. Arch Surg. 1999;134(5):477-485. doi:10.1001/archsurg.134.5.477
We hypothesized that hand-assisted laparoscopic surgery (a new technique that involves a surgeon's hand passing through a pneumoperitoneum-protecting sleeve device and assisting in laparoscopic surgery) is feasable and outcomes are comparable to purely laparoscopic procedures in selected cases.
A prospective, multicenter, nonrandomized, noncontrolled study was conducted with the participation of expert laparoscopic surgeons.
Academic and community medical centers in 16 states.
Any patient 18 years or older requiring abdominal surgery and determined to be suitable for laparoscopic surgery.
Main Outcome Measures
Incision size, duration of the procedure, conversion rate to an open technique, detection of subtle disease, return of bowel function, length of hospital stay, complication rate, and subjective evaluation.
The device was used in 58 patients for 24 different procedures, most commonly during colectomy (n=21) and splenectomy (n=7). Twenty-two percent of cases required conversion to open technique because of failure to maintain pneumoperitoneum or failure to complete the anticipated operation by this method. Average incision size was 7.6 cm. Mean duration of all procedures was 223 minutes (range, 110-415 minutes) and for nonconverted procedures was 178 minutes (range, 65-540 minutes). Preoperatively undetectable, subtle disease was palpated in 14 patients (24%). Mean length of hospital stay for all patients was 7.9 days and for the nonconverted group was 6.7 days. Twenty-four percent of patients developed complications, most commonly either wound complications (n=4) or prolonged ileus (n=3). In 58% of cases, surgeons thought that the technique shortened surgery, and 88% of surgeons found the technique "helpful" in all the completed procedures.
This technique seems to be a useful tool in the management of cases that either are too complex or take too long to be managed with purely minimally invasive techniques. To further define the potential benefits of this technique in selected procedures, prospective randomized trials are needed.
MINIMALLY INVASIVE surgery has revolutionized general surgery during the past 10 years. Laparoscopic cholecystectomy is currently the operation of choice for symptomatic gallstone disease, and the laparoscopic approach has also been used in the management of appendicitis, hernias, gastroesophageal reflux, and numerous other disease processes.1- 5 In fact, laparoscopic surgery is increasingly being used as an alternative to conventional open surgery because of several advantages over conventional open procedures: less trauma and pain, reduced hospitalization, and quicker recovery.
However, for more advanced surgical procedures, the acceptance of the minimally invasive approach has been slower than expected. This slow acceptance reflects a number of factors. First, performing major organ resections requires exceptional technical skills in laparoscopic tissue handling and manipulation. Given the limited number of training programs currently available for advanced laparoscopic surgery, only a select group of surgeons will acquire the necessary expertise in the foreseeable future. Second, current laparoscopic instrumentation is often inadequate for proper visualization and complex manipulation of intra-abdominal organs, and the inappropriate use of these instruments may jeopardize patients' safety. Third, many surgeons, other physicians, and third-party payers argue that increased surgery time and surgical costs associated with complex laparoscopic procedures may negate the benefits of minimal access surgery,6 despite the documentation that operating time can effectively be reduced with training and expertise.7 Finally, the lack of tactile feedback, which is an essential means by which surgeons identify structures and maintain safe dissection, prevents many surgeons from performing advanced minimally invasive procedures. The oncologic safety of laparoscopic procedures has become an additional source of debate.8
The previous observations led to the development of a device that allows insertion of a hand into the abdominal cavity while maintaining pneumoperitoneum, enabling the surgeon to perform the operation according to the principles of open surgery while retaining many of the advantages of a laparoscopic procedure. The Dexterity Pneumo Sleeve and protector retractor (Pilling Weck Corp, Raleigh, NC) functions similar to a trocar cannula. The device provides access to the abdominal cavity while maintaining pneumoperitoneum. Unlike the trocar cannula, the device allows the surgeon's hand to pass through a relatively small abdominal incision. Once in the abdominal cavity, the surgeon's hand provides haptic feedback, which assists in the performance of the procedure. Use of this technique may provide major advantages during laparoscopic surgery.
Initial reports about this technique were favorable,9- 11 and to further evaluate the usefulness of the Dexterity Pneumo Sleeve system and the efficacy of hand-assisted laparoscopic surgery we initiated a prospective, multicenter, noncontrolled clinical trial. In this study we report our experience based on 24 different types of hand-assisted laparoscopic procedures performed in 58 patients.
A national, collaborative, single-arm study was organized through the Southern Surgeons' Club Study Group, with industry supplying the sleeve device and initial training. Surgeons were trained at either Duke University Medical Center, Durham, NC, or the Advanced Laparoscopy Training Center in Marietta, Ga. The study was conducted at academic and community medical centers and was approved by the institutional review boards of the participating institutions. The 27 surgeons involved in the study practiced in the following states: California (n=4), Colorado (n=2), Florida (n=1), Georgia (n=2), Kansas (n=1), Massachusetts (n=2), Mississippi (n=1), Missouri (n=1), Nebraska (n=2), North Carolina (n=2), Ohio (n=2), Pennsylvania (n=1), Texas (n=2), Virginia (n=1), Washington (n=2), and Wisconsin (n=1). All the surgeons had reasonable experience in advanced laparoscopic procedures.
In total, 63 patients requiring abdominal surgery were found to be suitable for laparoscopic surgery in conjunction with the Dexterity Pneumo Sleeve system and were enrolled in the study. General inclusion criteria included (1) being 18 years or older and (2) undergoing any abdominal surgery. General exclusion criteria included (1) being younger than 18 years, (2) participating in another study with any investigational device within the past 30 days, and (3) having a contraindication for treatment with the Dexterity Pneumo Sleeve and protector retractor (eg, a dermatologic condition because of the adhesive component). Patients who fulfilled the above inclusion and exclusion criteria signed an informed consent form. The surgeons tested the device under conditions in which they faced difficulties in completing procedures in a purely laparoscopic approach or, given the complexity of the cases and the need for tactile feedback, decided to start with the hand-assisted technique.
The sterile and disposable trial device had 6 components: the Dexterity Pneumo Sleeve, a protector retractor, absorbent roll, incision template, gown sleeve cover, and sterile lubricant (Figure 1). The incision template is a disk of paper or a similar material that is used to mark the incision site and the location for the sleeve application. The protector retractor has an open-ended cylinder with a flexible ring at each end. One ring is inserted through the incision into the peritoneal cavity and the other remains outside the incision. The retractor lines the wound and holds the incision open and protects it against wound contamination.
The Dexterity Pneumo Sleeve device is approximately 86.36 cm long and 24.13 cm wide and is made of a biocompatible, sealable, polyolifin-type material. The distal (patient) side of the sleeve has a fenestration and an adhesive flange for attaching to the patient's abdomen. A valve located in the sleeve's lumen is constructed to close as carbon dioxide escapes from the peritoneum through the fenestration. The proximal (surgeon) end of the sleeve has a cuff (constructed of a Velcro strap or molded plastic) that is designed to secure the sleeve to the surgeon's arm to prevent leakage of carbon dioxide. The absorbent roll is 10.16 cm long and 0.95 cm in diameter. It is tucked under the top (outside) ring of the protector retractor to prevent fluids from contacting the skin in the area on which the adhesive will be placed.
The gown sleeve cover is a sterile, disposable device that can only be used in conjunction with surgery gowns that are gas permeable. It is placed over the surgeon's arm to prevent leakage of insufflation gas through the gown material. The sterile lubricant is used to facilitate insertion of the surgeon's hand through the protector retractor. It is best applied to the retractor with a standard gauze bandage before the Dexterity Pneumo Sleeve is attached to the patient.
Surgeons chose to use the sleeve device either to improve the efficiency of a currently accepted laparoscopic procedure or to perform a more complex procedure not usually done with minimally invasive techniques. Use of the trial device was discontinued during surgery when any of the following occurred: (1) inability to perform the surgery, (2) intolerable adverse effects, or (3) inadequate functioning of the device. Discontinuation of use of this device did not indicate withdrawal from the trial.
The effectiveness of the treatment was assessed with regard to the evaluation of multiple end points, which included length of incision, number and size of trocars, duration of the operation, tissue removal and size, conversions to an open procedure, product evaluation, surgeon glove size, insufflation pressure, complications, infection, bowel function, and length of hospital stay.1
Statistical analysis was performed using the Student t test assuming unequal variances as appropriate, with P<.05 representing significance.
A total of 62 patients were enrolled in the study, but the device was not used in 4 patients. The most common reason for not using hand-assisted surgery was because the surgeon thought that the procedure could be adequately done with a purely laparoscopic approach. Overall, 24 distinct procedures were performed in 58 patients (Table 1). The average age of patients was 57 years (range, 32-84 years), and their mean weight was 79 kg (range, 45-172 kg).
The most common procedure performed using the Dexterity Pneumo Sleeve device was colectomy (n=24), either as a single procedure (n=19) or in combination with another operation (n=5). Splenectomy was carried out in 7 patients, and Nissen fundoplication and gastric bypass were each performed 3 times. In 3 patients, laparoscopic cholecystectomy was undertaken first, followed by a hand-assisted procedure (1 common bile duct exploration, 1 ileal resection, and 1 partial gastrectomy). In addition, 2 Whipple procedures and various other complex operations were performed using the hand-assisted laparoscopic technique. A summary of cases with general patient data and mean operation times is shown in Table 1.
Average incision size to introduce a hand was 7.6 cm (range, 7.0-9.5 cm), which corresponded well with the average glove size of 7.4 cm. The exact positioning of the hand-assisted device depended on various factors, such as the surgeon's dexterity, comfort, and target area. The incision was placed in the midline in 19 patients, on the right side in 12 patients, on the left side in 17 patients, and in either the horizontal or vertical suprapubic position in 8 patients. In general, 2 to 3 additional laparoscopic trocars were introduced based on the situation and the surgeon's preference. Average insufflation pressure was 13.3 mm Hg (range, 8.3-15.0 mm Hg). The major function of the assisting hand included tissue manipulation (100%) and abdominal exploration (84%). Previously undetected disease was identified in 14 patients (24% of all patients). Of 25 patients diagnosed as having cancer, 5 (20%) were found to have previously undetected disease (Table 2).
Participating surgeons were asked to quantify the relevance of the presence of their hand in the abdomen while performing laparoscopic surgery. On a scale from 1 to 5 (5 being the best), for the purpose of abdominal exploration the overall satisfaction rate was 4.36. The assisting hand's utility in retraction and blunt dissection were equally rated as 4.60. The role of the hand-assisted laparoscopic technique in the control of hemorrhage was rated as 4.05. In 33 cases the operating surgeon had the impression that use of the hand-assisted technique considerably shortened operation time, by an average of 70 minutes.
Overall, 13 operations (22%) had to convert to an open procedure for various reasons, which are listed in Table 3. In 4 of these operations there was an initial plan to convert to an open procedure because certain parts of the procedures were easily performed through the limited incision of the Dexterity Pneumo Sleeve device. Four cases were converted because of leakage of pneumoperitoneum through the device. Other cases that required conversion to an open procedure included 2 liver resections for hemangioma, a paraesophageal hernia repair, a gastric bypass procedure for morbid obesity, and a total abdominal colectomy for pseudocolonic obstruction.
Tissue removal through the protector retractor was carried out in 37 cases (64%) (Table 4). In 8 cases, 11 additional Dexterity Pneumo Sleeve devices were needed to complete the procedure. Reasons for device replacement included gas leakage (n=6), problems with applying the device (n=3), enlargement of the incision (n=1), and the device being accidentally dropped on the floor (n=1).
Inadequate sealing and gas leakage was the most commonly encountered device-related problem during the trial. Adhesive leakage was noted in 14 cases (24%), sleeve leakage in 10 cases (17%), and cuff leakage in 4 cases (7%). Although the mean weight of patients was higher in those in whom leakage problems were recorded (83.3 vs 75.7 kg), the difference was not statistically significant (P=.28). Overall impression of participating surgeons with the device was rated 4.5.
Skin complications (blistering and rash) at the site of the adhesive were recorded in 2 patients. At the site of the Dexterity Pneumo Sleeve, there was 1 wound infection (a vertical banded gastroplasty performed for morbid obesity in a diabetic patient), and a seroma was noted in another patient after a sigmoid resection for diverticulitis. Infection at the skin staple site was noted in a patient who underwent gastric bypass procedure for morbid obesity. The postoperative complications are listed in Table 5.
The average number of postoperative days before return to a regular diet and the average hospital stay for uncomplicated cases of left colectomy, splenectomy, and Nissen fundoplication (which were the most commonly performed procedures in the series) are listed in Table 6.
The evolution of laparoscopic surgery experienced its peak during the early 1990s with the rapid acceptance of laparoscopic cholecystectomy.12 This change in surgical practice was followed shortly by other procedures, such as inguinal and abdominal hernia repair, appendectomy, colon resection, and Nissen fundoplication. The transition to more complex laparoscopic operations has apparently slowed down, which mainly reflects the technical difficulties and the safety concerns associated with these advanced procedures.
The recent introduction of the Dexterity Pneumo Sleeve device allows one to insert a hand (usually the nondominant hand) into the abdominal cavity during a laparoscopic procedure without the subsequent loss of pneumoperitoneum. Although the technique is appealing, immediate concerns were raised regarding the efficacy and the minimal invasiveness of the resulting operation. This national, prospective, multicenter, noncontrolled clinical trial was initiated by the Southern Surgeons' Club Study Group to identify potential applications, advantages, and disadvantages for the hand-assisted laparoscopic technique.
Colorectal cases constituted almost half of the entire series of 58 patients (26 cases). Despite the considerable caseload, laparoscopic colorectal surgery has not gained popularity among most colorectal surgeons. This only partly reflects the lack of technical expertise in advanced laparoscopic procedures. Controversial results regarding oncologic safety, including port site recurrence, and excessive operating time and associated costs have discouraged many to approach colorectal malignancies with the minimal access technique.13 The hand-assisted laparoscopic technique may provide a solution to some of these concerns.14
In our series, the average operating time for hand-assisted laparoscopic sigmoid colectomies (149 minutes) and the average length of hospital stay (6.4 days) were similar to those of most published laparoscopic colectomy series.7,15 Although this is only an initial experience with the technique, these results suggest that the purely laparoscopic and the hand-assisted techniques do not significantly differ in terms of minimal invasiveness for colon resections. These findings give credence to the belief that insertion of a hand will make the surgeon more efficient because initial experience with the hand-assisted technique resulted in operating times that have been achieved only after considerable experience in the laparoscopic series. This reflects a steeper learning curve for hand-assisted laparoscopic surgery for colon resections.16 The fact that almost half of the total series were colorectal cases (and only 2 of them required conversion to open surgery) indicates that colorectal surgery may be the subspecialty that could benefit most from the hand-assisted technique.
Because a limited laparotomy is required to remove the resected specimen, it seems logical to make the small incision at the beginning of the procedure. This may address concerns regarding operating time, related costs, and oncologic safety. Inserting a hand makes tissue manipulation (exploration, blunt dissection, and retraction) considerably easier and, therefore, increases the surgeon's confidence. Should a hemorrhagic complication occur, a bleeding vessel can more easily be controlled and blood loss minimized, providing the surgeon with valuable time to plan a strategy for problem resolution—even conversion, if necessary. After the colon has been fully mobilized, an extracorporal anastomosis can be performed through the small incision.
Port site recurrence has been a major argument against laparoscopic surgery for malignant lesions. Results of a recent prospective randomized trial,17 however, demonstrate that wound recurrence in open surgery and port site recurrence in laparoscopic surgery have an equal probability. Although in vitro evidence is controversial, it is increasingly accepted that it is more likely to be inadequate surgical technique and wound protection that account for tumor recurrence at the port site or in the abdominal incision.18,19 In general, we believe that resected specimens should only be removed in a specimen bag (or through a protected port) and that direct contact between the abdominal wall and the resected tissue should be avoided. Specimen removal through the protector retractor was performed in 36 cases (Table 4). The protector retractor portion of the Dexterity Pneumo Sleeve system provides excellent wound protection throughout the procedure by covering the entire surface of the incision. If a specimen containing neoplastic tumor cells is being removed through the protected wound, the likelihood of tumor seeding in the incision should be minimal. Our study does not contain long-term follow-up information, and, therefore, this issue needs to be addressed by long-term randomized prospective trials in the future.
One of the major arguments against the use of laparoscopy in the management of malignant disease is the lack of tactile sensation, which has been an essential tool of the surgeon in the detection of covert metastases in open operations. The lack of the opportunity to blindly explore abdominal contents and to identify accidental findings not otherwise seen with the laparoscope has discouraged many surgeons from the routine application of the minimally invasive technique in their practice.
A major advantage of the hand-assisted technique over the purely laparoscopic approach is the ability to identify previously undetected disease only recognizable by palpation (Table 2). In our series, previously undetected and unsuspected lesions were identified in 14 cases, half of which had oncologic relevance. Metastatic implants, tumor extension, or even incidental findings can effectively be localized by palpation. These findings confirm the potential utility of the hand-assisted technique in the minimal access management of malignant tumors.
Seven splenectomies were performed during the trial. The average operating time was 171 minutes, although almost all the operations were performed on enlarged spleens, which typically are associated with longer operating times. One surgeon would not have attempted the laparoscopic approach without the Pneumo Sleeve device, and another case would have been converted to open surgery because of technical difficulties related to the enlarged spleen. One of the challenges of laparoscopic splenectomy is the successful retraction of the spleen. Current laparoscopic retractors often do not safely deal with large spleens. Having a hand inside the abdomen is the best potential retractor, and the ability to identify major vessels by palpation is helpful in avoiding serious bleeding complications. The spleen was successfully removed through the protector retractor either whole or morcellated, depending on its size. Only 1 (14%) of 7 cases had to be converted in the series. Average hospital stay after the procedure was 3.8 days, which is slightly longer than what has been reported by most series of laparoscopic splenectomies.20 Recent series21,22 report mean operating times of 190 to 265 minutes, with conversion rates ranging between 25% and 50% for enlarged spleens. Given the fact that the hand-assisted laparoscopic cases in our series consisted almost exclusively of enlarged spleens, which would be difficult, if not impossible to remove purely laparoscopically, the results seem superior to those of laparoscopic splenectomy. Preoperative embolization before laparoscopic splenectomy recommended by some authors is not necessary if the hand-assisted approach is used.21 Overall, the hand-assisted technique proved to be a useful tool in minimal access splenectomy, seemingly making the procedure safer and shorter, especially in cases of splenomegaly.
Three Nissen fundoplications were performed successfully using the technique. The operating times and hospital stays were slightly longer than those of laparoscopic Nissen fundoplication.23 Two surgeons found that the hand-assisted technique was difficult and experienced setup problems (hands were too close to camera). It seems now that the skills necessary to perform laparoscopic Nissen fundoplication can be easily developed, and because recent studies confirm the excellent long-term results with the purely laparoscopic approach, the hand-assisted technique will not be needed in the management of gastroesophageal reflux disease.5,23,24
The technique was successfully used for other advanced procedures such as liver resections, Whipple procedures, gastric bypass, partial gastrectomy, and others (Table 1). Overall impression about the technique was favorable, but based on this limited experience it is still too early to form a definitive statement about the utility of hand-assisted laparoscopy in the management of these cases. Sporadic reports confirm our findings that the assisting hand proved to be useful in the precise localization of tumors, adhesiolysis, organ retraction and manipulation, and hemorrhage control.11,25- 27 Although, our series did not include hand-assisted laparoscopic nephrectomies, some reports have been published with favorable experiences.28 More experience is required to explore the pitfalls and benefits, but the initial results are encouraging.
Thirteen operations were converted to an open technique for various reasons; however, 4 of these were planned conversions, either to perform extracorporal anastomosis or to do a part of the procedure in an open fashion. One of the key elements of successful minimal access surgery is flexibility and quick adaptation of existing possibilities. This may include rearranging instruments using the existing ports, placing new ports, or, in the case of hand-assisted laparoscopic surgery, using the incision for the Dexterity Pneumo Sleeve device to perform open surgery. This flexibility is perceived as a major advantage of hand-assisted laparoscopic surgery.
Five cases required conversion when the surgeons could not safely complete the procedures. In 4 cases conversion was needed because the device did not function properly and pneumoperitoneum could not be maintained. In fact, air leakage was the most commonly encountered problem during the entire trial. Leakage was noted at the adhesive, at the cuff, or at the sleeve in 28 cases, forcing replacement of the device 6 times. In addition, problems with applying the device and eventual replacement were noted in 3 cases. These difficulties may be a result of insufficient experience, but it was the major determinant of surgeon satisfaction and overall success. Device leakage was unrelated to patient weight. It is our belief that difficulties with leakage and application of the device will need to be addressed in subsequent generations of the product, otherwise these annoying and distracting events may eventually discourage surgeons from using the device.
Fourteen postoperative complications were noted in the entire series, and most occurred after complex abdominal surgery. Only 2 minor wound infections occurred at the site of the incision: 1 seroma and 1 wound infection after a sigmoid colectomy and a vertical banded gastroplasty, respectively.
These data support the concept that hand-assisted laparoscopic surgery is a useful adjunct in the armamentarium of the general surgeon. Based on our limited initial experience, we recommend possible use of the hand-assisted technique in the following situations: (1) any major solid or hollow organ resection that will require a limited incision for specimen removal; (2) complex laparoscopic procedures that currently have extensive operating time, higher costs, and higher conversion rates than open procedures; (3) as a replacement to conversion to open surgery in cases in which temporary tactile feedback of manual assistance is required; and (4) major abdominal procedures considered too difficult for laparoscopic surgery. In this study, there was an apparent benefit for selected cases of splenectomy when there is splenomegaly, for colorectal resections, and other isolated complex cases with this approach. To further define the potential benefits of this technique in the management of oncologic problems, prospective randomized trials are needed. The availability of this device may encourage some surgeons who have not developed enough advanced laparoscopic expertise to pursue minimally invasive procedures. However, at this time we recommend use of hand-assisted laparoscopy only for experts in laparoscopic surgery and for procedures that either are too complex or take too long to be managed with purely laparoscopic surgery.
This study was partially sponsored by a grant from the Pilling Weck Corp, Raleigh, NC.
Presented at the 79th Annual Meeting of the New England Surgical Society, Toronto, Ontario, September 25, 1998.
Corresponding author: William C. Meyers, MD, Department of Surgery, University of Massachusetts Medical Center, 55 Lake Ave N, Worcester, MA 01655.
Dougald Macgillivray, MD, South Portland, Me: What we have seen today is the experience of the Southern Surgeons' Club in a multicenter feasibility trial of a device that allows for the surgeon to use his or her hand during complex laparoscopic procedures. These results indicate that this device can be used successfully in a variety of complex laparoscopic operations. The operative times reported for the most part are compatible with what one would expect had the procedures been done using an open approach.
This is remarkable for a new technical device that was being used by many different surgeons on relatively few cases. The device seems to be safe in that the reported complications were mostly minor or ones that you would expect to be related to the procedure itself rather than to the utilization of the device. One could question the judgment of using a new technical device that is still unproven in some of these challenging operations, but, as was pointed out, this was a feasibility trial.
I agree with Dr Foley that if an incision is required to remove a specimen or to perform anastomosis that it is sensible to make the incision early and to use it for the difficult portion of the dissection. This device allows for the utilization of a needed incision while maintaining pneumoperitoneum. It allows for the protection of the wound, which appears to be important in reducing tumor implantation. The ability to use tactile sensation during the larapascopic procedure is a major potential advantage of this device. However, I think they slightly overemphasize their ability to detect lesions in the manuscript.
Twenty-seven surgeons participated in this study, but the device was only used in 58 patients.
What factors limited the acceptance for utilization of this technique? A conversion rate of 22% is high for a motivated group of highly skilled laparascopic surgeons. A technical failure of the device seemed to be a reason for many of these conversions. Has the device recently been modified or improved?
In a group of patients who had a colon resection a regular diet was started on postoperative day 3.5, but the average hospital stay was 6.4 days. What accounted for the delay in discharge of this group of patients?
One could argue that some of these procedures could have been accomplished using a purely laparascopic approach or by extending the incision 2 or 3 cm by an entirely open approach. Do you think that by reducing an abdominal incision by a few centimeters the operative morbidity will be reduced enough to justify the use of this device? And do you plan on conducting a randomized trial to more rigorously test the potential benefits of this device?
Dr Foley and his associates have presented an interesting and innovative technique and they have challenged us to consider expanding the field of minimally invasive surgery to more complex operations.
Dr Foley: To answer your questions in regard to the number of surgeons who participated and why only 58 patients underwent the procedure, the device was supplied by industry and there was a limit on the number of devices supplied. We are currently working with Smith & Nephew Inc at the University of Massachusetts Medical Center to improve the device and minimize gas leakage. The new device has an additional bubble that lies in the abdominal cavity up against the abdominal wall and when insufflated prevents leakage of gas during the procedure.
As far as the delay in discharge, it's unclear exactly why these patients actually started their diet on average postoperative day 3.5 and they went home on postoperative day 6. There were a wide variety of surgeons in the study, and we couldn't really delineate the reason for delay in discharge.
As far as the justification for the use of the device, we don't know if the operative morbidity will be less than that with laparotomy. This is the question we hope to answer in future studies. With full laparotomy it is unclear exactly why patients develop postoperative ileus or complications from a larger incision. Is it due to desiccation, or increased abdominal retraction, etc? By actually reducing the incision size and maintaining adequate exposure via laparoscopy, we are able to perform these procedures, and these data suggest that potentially it would be of benefit. Also, we have an ongoing, randomized trial at the University of Massachusetts Medical Center, randomizing patients either to laparascopic colectomy or to hand-assisted laparascopic colectomy, so we should have some data from that in the near future.
Walter Goldfarb, MD, Portland, Me: This is the first prospective 1-armed study reported!
Charles Shoemaker, MD, Newport, RI: One of the problems with this new explosive technology is how to get it out into the community. Having been there and seen the pressure both from patients and industry, perhaps this concept of handscopic surgery is the way to go. Trying to introduce this pure laparascopic surgery into the community is very difficult. Your hospital has not given you credentials for a new procedure, and it is difficult to bring down an expert from Brown [University] each time a new procedure is introduced. This is a nice intermediate way to get the traditional surgeon, who's comfortable feeling the tissue, to gradually move in the direction of laparascopic surgery. It's a concept that we really must pay attention to.
Blake Cady, MD, Providence, RI: I can't resist. I can foresee the next technical advance in modern surgery, the introduction of both hands into the abdominal cavity! My question is, how soon do you think that new advance will occur?
Dr Foley: We actually have 2 single-arm studies in progress trying to answer that question.