Product Review: Technologies for laparoscopic contained tissue extraction

October 1, 2014

Newer surgical techniques to facilitate the extraction of uterine tumors in a containment system have sufficiently advanced to make the small risk of spreading an unanticipated malignancy even smaller.

 

Dr. Greenberg is Chief, Division of Gynecology, Brigham & Women’s Faukner Hospital, Harvard Medical School, Boston, Massachusetts.

He reports receiving intellectual property rights/holding a patent relating to the design of a tissue extraction bag. 

 

 

 

 

Dr. Ajao is a Fellow in Minimally Invasive Gynecologic Surgery, Brigham & Women’s Hospital, Harvard Medical School, Boston, Massachusetts.

He has no conflicts of interest to report with respect to the content of this article.

 

 

 

Morcellation technologies were developed to facilitate the removal of large amounts of tissue through small laparoscopic incisions. These techniques have been notably useful in surgeries involving the uterus with a particular focus on procedures for fibroids (leiomyomas). The advantages of using laparoscopic approaches compared to laparotomy to treat uterine fibroids include a lower risk of infection, less blood loss, less postoperative pain, and more rapid return to full activities.1 However, recent data have demonstrated that intracorporeal morcellation of tumor tissue without the use of a containment system may have a greater potential to spread tumor tissue throughout the peritoneal cavity than previously recognized.2

While the absolute risk of encountering an unanticipated uterine malignancy is small (1:350 to 1:1000),3-5 newer surgical techniques to facilitate the extraction of uterine tumors in a containment system (contained tissue extraction or CTE) have sufficiently advanced to make this small risk even lower.

Here we focus on a few of the newer techniques and technologies in this niche. This is a rapidly evolving space that may be dramatically different in a short period of time.

Insufflated contained tissue extraction

The core of the techniques discussed here was first described by Shibley et al in 2012.6 Common features include the following steps:

--Introduction of a specimen bag into the abdomen
--Placement of the surgical specimen inside the bag
--Exteriorization of the neck of the bag through one of the incisions
--Intracorporeal insufflation of the bag with concomitant desufflation of the surrounding abdomen.
--Introduction of a laparoscopic camera and power tissue morcellator into the insufflated bag
--Power tissue extraction of the specimen entirely within the confines of the bag
--Removal of the bag from the abdomen

In general terms, the most significant variation with insufflated contained tissue extraction (iCTE) methods is single-site incision versus a multiport technique. With the single-site technique, the single-site port is uncapped, the specimen bag is introduced through the single site port, and the port is recapped. Next the specimen is placed into the bag using traditional laparoscopic single-site techniques. The port is then uncapped and the neck of the bag is exteriorized through the port. The port is recapped with the bag’s edges enclosed within its rim and the bag is insufflated intracorporeally while the abdomen outside of the bag is desufflated. A power morcellator and a laparoscope can then be introduced through the single-site port and the specimen can be extracted, with the entire process fully contained. With the specimen extracted, the bag is removed and the procedure is completed as per routine.

With the multi-port technique, the specimen bag is introduced through a 12- or 15-mm port or directly through the largest incision already in the abdomen. The specimen is then placed into the bag and the neck of the bag is exteriorized through the largest incision. The 12- or 15-mm trocar is introduced into the bag through the neck and the bag is insufflated intracorporeally while the abdomen outside of the bag is desufflated. With the bag insufflated inside the abdomen, a 5-mm trocar is used to puncture the bag near the top to provide an access port for visualization and insufflation. Once the secondary port in secured inside the bag, the trocar in the neck is removed and replaced with a power morcellator and the specimen can be extracted. The entire process is contained. With the specimen extracted, the bag is removed and the procedure is completed as per routine.

 

 

Technologies to facilitate iCTE

Containment bags

At the core of all the variations of iCTE is the extraction bag. In his original description of his technique, Shibley reported using a Lahey bag.

Lahey bags

Lahey bags or “isolation bags” are large, sterile, transparent PVC bags initially designed to cover limbs during sterile surgical procedures. These bags are produced by several manufacturers (eg, 3M Steri-Drape Isolation bag 1003, the Iso/Drape Isolation bag). Typically they measure about 50 x 50 cm with a drawstring at the neck. Although the Lahey bag can accommodate virtually any size specimen, it can be unwieldy within the confines of the closed abdomen. Also the material is not overly robust and can easily tear if pulled too hard with laparoscopic instruments-especially during the process of introducing the bag into the abdomen.

Rip-stop nylon

Given the limited strength of the Lahey bags and the ease with which they can tear with manipulation, many surgeons have turned to rip-stop nylon bags. However, not all rip-stop nylon products are the same. Because the manufacturing of these products requires stitching or welding of sheets of material, the seams are further treated (usually with polyurethane) to prevent leakage when they are subjected to the higher pressure of insufflation. Given these parameters, 2 products are often used: the LapSac and the Eco Sac.

LapSac – Cook Medical’s LapSac is the only specimen retrieval product on the market today that carries an FDA-approved indication for tissue morcellation.7 Manufactured from 2 sheets of rip-stop nylon with polyurethane coating over the seams and a drawstring at the neck, the LapSac comes in several sizes, the largest measuring 8 x 10 cm (1500 mL). Although the LapSac performs admirably with smaller specimens and when used to manually morcellate tissue through a mini-laparotomy, its small size makes it of limited use for iCTE.

Eco Sac – Like the LapSac, the Eco Sac (Figure 1) is constructed from stitched rip-stop nylon coated with polyurethane, but it has several features that make it easier to use with iCTE techniques.

The EcoSac 230. Image courtesy Espiner Medical Ltd.First, it comes in much larger sizes, with the largest Eco Sac 230 accommodating 3100 cc. While the larger size increases the amount of material taking up visual space within the limited confines of the pelvis, when insufflated, the 3100-cc bag is perfect for most procedures. Second, the EcoSac has 4 loops secured to the edges that make introducing and manipulating the bag much easier.

 

 

 

 

Trocars

With a multiport iCTE technique, a lateral puncture into the bag is necessary to provide a port for visualization and insufflation. Any standard 5-mm trocar can be used, but the Kii advanced fixation (balloon) shielded bladed trocar in the 5 x 150-mm configuration is ideal for this application (Figure 2).

The 5mm Kii Advanced Fixation Trocar. Image courtesy Applied Medical.The balloon at the end minimizes the risk of spillage and helps pull the walls of the bag closer to the abdominal wall. The shielded bladed tip facilitates penetrating the bag-even a rip-stop nylon bag. The added length of the 150-mm configuration allows for more flexibility in accessing the bag’s interior when using smaller bags or more lateral ports.

Minilaparotomy contained tissue extraction

As compared with the Shibley-style iCTE, the steps involved with minilaparotomy contained tissue extraction (mlCTE) are identical except that there is no insufflation of the bags and manual morcellation is employed rather than power morcellation. (Power morcellators should never be used when the tip of the morcellator blade cannot be fully visualized.)

After the specimen is placed into the bag, the neck of the bag is exteriorized and the tissue within the bag is morcellated into smaller pieces with either a knife or scissors and extracted. This technique may be somewhat easier for some surgeons to quickly adopt, but morcellating the tissue without cutting the walls of the bag can be challenging-especially through small incisions.

Technology to facilitate mlCTE

As with iCTE, the choice of bag is important. With mlCTE, however, smaller bags can be used because insufflation is not involved. Surgeons’ options include a myriad of traditional plunger-style deployable endoscopic tissue removal bags manufactured from either PVC or rip-stop nylon, although these bags do not exceed 1850 cc in capacity.

Many companies make PVC plunger-style deployable endoscopic tissue removal bags. In rip-stop nylon, the most popular plunger-style deployable endoscopic tissue removal bags are produced by Anchor Surgical in their Tissue Removal System. Importantly, the seams on these bags are RF-welded rather than stitched, making them less likely to leak than non-coated, stitched rip-stop nylon bags.

 

 

Other products that can be useful for mlCTE are surgical wound retractors such as the Alexis O wound retractor/protector, Mobius mini, and the SurgiSleeve. For larger specimens which require a large mini-laparotomy incision (4–5 cm), the rings can be deployed inside the neck of the exteriorized bags to minimize the risk of inadvertently cutting the bag.

For smaller specimens just marginally too large for an incision, the Schellpfeffer Forceps are a clever means of extracting a contained specimen without morcellation (Figure 3).

The Schellpfeffer Forceps. Image courtesy Laparoscopic Technologies Inc. In a manner similar to obstetric forceps, the Schellpfeffer blades are placed around a bagged specimen and the whole contained package is delivered through the incision.

Summary

Few innovative techniques have evolved in a purely linear trajectory. Rather, most involve a few steps forward balanced by a few steps back. The most recent controversy involving morcellation should serve as a reminder to surgeons that complacency is the enemy. We must constantly seek to improve our techniques to ensure the best outcomes for our patients. 

 

References

1. Nieboer T, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;3:CD003677.

2. Seidman MA, Oduyebo T, Muto MG, et al. Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms. PLoS One. 2012;7(11):e50058.

3. Food and Drug Administration. Quantitative assessment of the prevalence of unsuspected uterine sarcoma in women undergoing treatment of uterine fibroids: summary and key findings. http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM393589.pdf. Accessed July 29, 2014.

4. Wright J, Tergas A, Burke W, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. 2014;doi: 10.1001/jama.2014.9005. [Epub ahead of print]

5. Society of Gynecologic Oncology. SGO position statement: Morcellation. https://www.sgo.org/newsroom/position-statements-2/morcellation/. Accessed July 29, 2014.

6. Shibley KA. Feasibility of intra-abdominal tissue isolation and extraction, within an artificially created pneumoperitoneum, at laparoscopy for gynecologic procedures. In: Proceedings from the American Association of Laparoscopic Gynecologists; November 5–9, 2012; Las Vegas, Nevada.

7. Cook Medical. LapSac. https://www.cookmedical.com/data/IFU_PDF/T_LPSC_REV1.PDF. Accessed August 6, 2014.