|Year : 2021 | Volume
| Issue : 1 | Page : 8-12
Can spiral-shaped abdominal wall lift replace pneumoperitoneum in laparoscopic cholecystectomy? A randomised study
Shashi, Rajdeep Singh, Anurag Mishra, Lovenish Bains, PN Agarwal
Department of Surgery, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India
|Date of Submission||14-Aug-2020|
|Date of Acceptance||06-Jan-2021|
|Date of Web Publication||19-Feb-2021|
Dr. Rajdeep Singh
Department of Surgery, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi
Source of Support: None, Conflict of Interest: None
Background: A new design of abdominal lift system for gasless laparoscopy has been introduced in rural areas.
Aims and Objectives: To assess whether the new spiral design abdominal wall lift system has similar outcomes to standard pneumoperitoneum laparoscopic cholecystectomy.
Materials and Methods: Sixty cases of symptomatic gallstone disease scheduled for laparoscopic cholecystectomy were randomly assigned to gasless spiral abdominal wall lift or to standard pressure pneumoperitoneum, followed by cholecystectomy. Post-operative abdominal and shoulder tip pain, duration and ease of surgery and surgical site complications were compared.
Results: There was a significant difference in post-operative abdominal pain at 24 hours after surgery (P < 0.01). Shoulder tip pain was lower at 6 h (P < 0.01). The duration of surgery was comparable in both groups; the time taken decreased in the abdominal lift procedure with increasing experience. Conversion rate and surgical site complications were similar. There were comparable outcomes in terms of overall post-operative abdominal pain; shoulder tip pain; duration of surgery; conversions and post-operative complications between the two groups. Ease of surgery improved with number of cases over time.
Conclusion: Abdominal lift may be a valid alternative to pneumoperitoneum cholecystectomy with comparable outcomes in resource constrained areas.
Keywords: Abdominal wall lift device, cholecystectomy, gasless laparoscopy, pneumoperitoneum
|How to cite this article:|
Shashi, Singh R, Mishra A, Bains L, Agarwal P N. Can spiral-shaped abdominal wall lift replace pneumoperitoneum in laparoscopic cholecystectomy? A randomised study. Curr Med Res Pract 2021;11:8-12
|How to cite this URL:|
Shashi, Singh R, Mishra A, Bains L, Agarwal P N. Can spiral-shaped abdominal wall lift replace pneumoperitoneum in laparoscopic cholecystectomy? A randomised study. Curr Med Res Pract [serial online] 2021 [cited 2021 Mar 4];11:8-12. Available from: http://www.cmrp.org/text.asp?2021/11/1/8/309910
| Introduction|| |
Practically all laparoscopic procedures are done using carbon dioxide (CO2) pneumoperitoneum. Pneumoperitoneum has its limitations in case of cardiac and respiratory compromised patients, as hypercapnia has adverse effects on cardiac output.,, Post-operative shoulder tip pain is also a consequence of retained CO2. Further, in resource-limited areas, gasless laparoscopy is an attractive alternative to pneumoperitoneum. Gasless laparoscopy fell out of disfavour because previously used instruments caused suboptimal exposure of operative field and more pain due to stretching of abdominal muscles. There is a possibility of more wound infection and incisional hernia due to the bigger incision used. An instrument is now available which uses a spiral configuration to evenly lift the abdominal wall and perhaps overcome the purported disadvantages of abdominal lift devices.
| Materials and Methods|| |
Study design and randomisation
A randomised controlled study was conducted from September 2017 to April 2019 after approval from the Institutional Ethics Committee and included 60 patients (>18 years of age) with symptomatic gallstone disease falling in the American Society of Anesthesiologists Class 1 or 2. Pregnancy, concomitant procedure (e.g., for common bile duct stones or hernia), bleeding disorder and previous abdominal surgery were excluded from the study. Informed consent was obtained from all the study participants. The sample size calculated on the basis of a previous study was calculated as 17. It was decided to have a minimum sample size of 50 cases. The participants were randomly assigned to abdominal wall lift (Group 1) or standard pneumoperitoneum (Group 2) by computer-generated random number and allocated by sealed envelopes.
Group 1 (abdominal wall lift)
Patients were operated using a spiral lift device manufactured by STAAN Bio-Med Engineering Private Limited. A 1–2 cm incision was made in the subumbilical region by open technique and a finger swept to ensure there are no adhesions to the abdominal wall in the supraumbilical area. The end of the spiral device was introduced through this incision and adjusted in the upper half of the abdomen. The device is then attached to the lifting arm and elevated gradually over 2 min as air is allowed to enter. A 10 mm trocar is placed alongside the lift device through the same incision. Additional 5 mm ports were placed in the epigastrium, right anterior axillary line and midclavicular line, as in standard lap cholecystectomy. The rest of the steps are same as for conventional laparoscopic cholecystectomy. At the end of the procedure, the fascial incision at the umbilicus was closed with polyglactin/polyglycolic acid suture number 1 continuous.
Group 2 (standard pneumoperitoneum group)
Pneumoperitoneum was created using the open or closed (Veress’ needle) technique. The standard technique of laparoscopic cholecystectomy was followed. Subumbilical port site was closed with polyglactin/polyglycolic acid suture.
Long-acting local anaesthetic was instilled in gallbladder bed and infiltrated around incisions in both groups.
Post-operative abdominal and shoulder tip pain were assessed using the Visual Analogue Scale at 6, 24 and 48 h and at the time of suture removal (6th–8th day). Additional analgesic dose was provided if VAS was more than 3.
Duration of surgery was calculated from incision to closure in both groups. Fixing of abdominal lift stand to operation table was done beforehand, hence not included in the time calculation. ‘Ease of surgery’ grading was done by operating surgeons using simple grading score (8–10 score for a difficult surgery, 5–7 for mild difficulty and <4 for easy surgery).
Conversion to other modalities was considered – gasless to CO2 pneumoperitoneum and any conversion to open cholecystectomy.
Post-operative surgical site infection (as per CDC criteria) and wound dehiscence (defined as visible skin or fascial separation) were assessed at the time of suture removal. Follow-up was till 10th post-operative day (i.e., time of suture removal).
Statistical analysis was done using SPSS-19 software (IBM SPSS Statistics ver 19, Statistical Package for the Social Sciences, Armonk, New York, US). Qualitative data were calculated using the Chi-square test and quantitative data were expressed by mean and standard deviation, and the difference between means is tested using Student's t-test. P < 0.05 was considered statistically significant.
| Results|| |
Both the groups were comparable in terms of age and gender. There was a significant difference in mean body mass index (BMI) between the two groups: 20.30 ± 2.77 in gasless abdominal lift group and 22.63 ± 3.07 in standard pneumoperitoneum group (P < 0.01) [Table 1].
There was no significant difference in post-operative abdominal pain at 6 h; at 48 h and at 6–8th day; however, there was a statistically significant difference at 24 h.
Conversely, the shoulder tip pain was more at 6 h, but there was no significant difference in later assessments.
There was no difference in the duration of surgery in both groups (68.00 ± 18.59 min in Group 1 and 62.00 ± 22.07 min in Group 2 [P = 0.26]). However, it was noted that the initial cases using abdominal lift took more time than the latter cases, the mean difference between the first five cases and the last five cases being 12 min [Table 2].
Four cases were converted from gasless abdominal lift to standard pneumoperitoneum; two of these were because of small length of the abdomen (i.e., short stature) causing difficulty in safe placement of spiral instrument, one case was converted because of adhesions between the liver, colon and small bowel and one case due to malfunctioning of gasless lift equipment. One case was converted from standard to open cholecystectomy due to pericholecystic adhesions and difficult dissection.
The operating surgeons clearly rated more cases in conventional laparoscopic surgery using CO2 pneumoperitoneum as being easier.
Surgical site infection, wound dehiscence (gaping of the skin) after suture removal had comparable incidence in both groups.
| Discussion|| |
Carbon dioxide pneumoperitoneum has stood the test of time and shown to be a relatively safe and versatile agent. However, in remote areas such as in Northeast India, facility for refilling of CO2 cylinders is not easily available. In such areas, a technique which avoids the use of CO2 would be very useful. The gasless method has several other possible advantages: because there is no gas insufflation, the operator can apply unlimited suction and use conventional instruments to facilitate laparoscopic procedures. The threat of sudden loss of vision following a gas leak is also eliminated. CO2 insufflators and CO2 cylinders are also not required. Recurring expenses of specially designed laparoscopic ports is reduced, since simple valveless 5.5 mm diameter tubes can be used for the ports. This makes it extremely convenient for a surgeon who is providing services in a resource-constrained area. Other less thoroughly researched benefits may include improved safety; reduced rates of port site metastasis and reduced contaminations of the abdomen during contaminated procedures.,,
A gasless abdominal lift was introduced 25 years ago. However, it fell out of use due to the versatility of CO2 pneumoperitoneum, despite its shortcomings (especially its effect on the cardiac and respiratory systems). Further, the abdominal lift systems resulted in post-operative abdominal pain, possibly due to focal lifting pressure and rapid stretching of the abdominal wall. To overcome these drawbacks, a spiral-shaped lift device patented by Dr. Jesuden Ganaraj and STAAN technologies is in use in some rural areas, primarily for diagnostic and lower abdominal procedures. Gasless laparoscopy has also been described for gynaecological procedures, appendicectomy, diagnostic laparoscopy and some colorectal procedures.,,
Abdominal pain may be attributed to the wound itself and degree of stretch of abdominal muscles, especially if it is localised or evenly distributed. Interestingly, there was no difference at 6 h after surgery, which may be an effect of the local anaesthetic and analgesia given at the time of surgery. Abdominal pain was significantly more in the abdominal lift group on the morning after surgery, a reflection of the bigger incision and muscle stretch. Pain was similar thereafter. In a study by Koivusalo et al., a significantly higher incidence of post-operative abdominal pain in the abdominal wall retractor group was found in 8 out of 13 patients (P < 0.05) measured at 24 h postoperatively. Uen et al. measured abdominal pain using 10 cm VAS scale at 24 h and found no difference with a mean score of 4.4 ± 0.9 in the pneumoperitoneum group and 4.5 ± 0.9 in abdominal wall lift (P = 0.475).
Shoulder tip pain is due to entrapped carbon dioxide, which forms carbonic acid and causes pain. Stretch of the diaphragm may also play a role. One would expect similar pain if air gets entrapped, as is possible after abdominal lift procedures. However, this study showed more shoulder pain if carbon dioxide is used, but this difference is evident in the initial post-operative period only. The difference disappears within a day. However, it is to be noted that the VAS was never more than 3 in either group. Shrikhande et al. reported post-operative shoulder tip pain in 72% of gasless abdominal wall lift group, in contrast to the present study. The study by Koivusalo et al. was in line with our results, with one patient in the abdominal wall retractor group and seven patients in the conventional pneumoperitoneum group suffering from right shoulder tip pain at 24 h postoperatively (P < 0.05).
Duration of surgery may be considered as an objective measure of the difficulty encountered in surgery. All procedures were performed by surgeon's proficient in laparoscopic surgery, although with limited experience using the abdominal lift system. As expected, the time for completion of the procedure was higher in the initial few cases, but fell near to baseline by the fifth case. This represents the learning curve. Overall, there was no statistical difference between the two groups in terms of duration of surgery. The study by Talwar et al. favoured conventional pneumoperitoneum with a mean time of 31.55 ± 4.25 min versus 41 ± 7.89 for the abdominal retractor (P < 0.05). This difference may be explained by inclusion of set up time also.
One of the purported drawbacks of abdominal lift is limited visualisation. Conversions can be used as an estimate for the same. It is significant that in four (out of 30) patients, laparoscopic cholecystectomy could be completed after addition of pneumoperitoneum. It is said that pneumoperitoneum not only lifts the abdominal wall but also presses the bowel, giving more working space. This has not been an issue for lower abdominal surgery, where a steep Trendelenburg position moves the bowel away from the pelvic organs. For upper abdominal procedures, an additional port to retract the bowel may be advisable.
High BMI has been found to have indirect effect in terms of associated comorbidities like cardiac disease, but specifically, the abdominal weight has direct effect on the limitation of abdominal wall lift devices. This can be overcome by combining with low pressure (4–5 mmHg) CO2 insufflation. Although the present study had higher BMI in the pneumoperitoneum group (P < 0.01), there were no obese patients in either group. Hence, this artificial difference can be safely ignored for the purpose of this study, as can be inferred from there being no difference in the duration of surgery.
It is possible that the lift may interfere in the movement of instruments or be ergonomically uncomfortable. This was assessed by a subjective ‘Ease of surgery’ score. This score shows a trend towards easier surgery with time, which reflects the decreasing duration of surgery. Although not a validated score, it gives an idea of the subjective difficulty faced by the surgeon. As expected in a new procedure, the surgeons found it easier to perform conventional laparoscopic cholecystectomy, compared to the newer abdominal lift technique.
Short-term complications were assessed in this study. Surgical site infection and wound dehiscence (i.e., skin separation) was equal in both groups. It likely reflects other issues related to patient factors and tissue handling, rather than the technique employed.
The cost was not assessed as part of this study. However, it is possible that the recurrent cost of carbon dioxide will be offset by the one-time cost of the instrument, which is indigenously manufactured. It is even more cost-effective if valveless ports are used. An unquantifiable advantage is the possibility of using conventional surgical instruments instead of laparoscopic instruments. Gasless laparoscopy is not expected to replace conventional CO2 pneumoperitoneum; rather act as an alternative.
| Conclusion|| |
The abdominal lift technique is not inferior to conventional pneumoperitoneum for laparoscopic cholecystectomy. However, pericholecystic adhesions may require additional pneumoperitoneum for safe dissection.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]