507145
research-article2013
SRIXXX10.1177/1553350613507145Surgical Innovation XX(X)Holman et al
Innovative Technologies
Development and Clinical Implementation of a Hemostatic Balloon Device for Rectal Cancer Surgery
Surgical Innovation 2014, Vol. 21(3) 297–302 © The Author(s) 2013 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1553350613507145 sri.sagepub.com
Fabian A. Holman, MD1, Noortje van der Pant, MSc2, Ignace H. J. T. de Hingh, MD, PhD3, Ingrid Martijnse, MD3, Jack Jakimowicz, MD, PhD3, Harm J. Rutten, MD, PhD, FRCS3, and Richard H. M. Goossens, MSc, PhD2,4
Abstract Background. Surgery for locally advanced and recurrent rectal carcinoma can be associated with major blood loss. Objective. We developed a promising technique using a hemostatic balloon to stop uncontrollable bleeding. Design. Models were developed using pelvic magnetic resonance imaging scans, and these models were tested in a cadaveric study. Eventually a model was tested in a clinical setting. The Hemostatic Balloon Device was placed in patients in whom during surgery uncontrollable bleeding from the venous presacral plexus occurred. Settings. A tertiary referral hospital for locally advanced and recurrent rectal cancer. Patients. Patients receiving multimodality treatment for primary or recurrent locally advanced rectal carcinomas. Main Outcome Measures. First the developed prototypes were tested in a cadaveric study where the developing pressure on the pelvic wall was measured. Second, the Hemostatic Balloon Device was placed in patients in whom during surgery uncontrollable bleeding from the venous presacral plexus occurred. Results. The balloon was used in 9 patients. Median volume of blood loss was 7500 mL. In 8 patients treatment with the hemostatic balloon was successful. In 1 patient the balloon was dislocated cranially and the pelvis was packed with surgical gauzes. Limitations. These first results are promising but further research is needed to evaluate how effective the balloon is in controlling massive bleeding during rectal cancer surgery. Future perspectives include a possibly thinner silicon rubber that can be stretched more easily with a lower inflated volume. Discussion. The hemostatic balloon is a new and promising technique for accomplishing hemostasis with controllable pressure on the pelvic cavity wall and can be removed without the need for a second laparotomy. Keywords colorectal surgery, surgical oncology, surgical education
Introduction Colorectal cancer has a current worldwide incidence of more than 1 million new cases.1 Of all colorectal tumors, 30% is situated in the rectum. Rectal cancer constitutes a different entity in the colorectal cancer group, because the rectum has a closer relation to the surrounding tissues. Of all rectal cancer patients, 75% have a mobile tumor and 25% present themselves with a tumor extending into or beyond the enveloping mesorectal fascia. Free circumferential resection margins is one of the most important prognostic variables for oncological outcome for rectal cancer.2,3 After resection, 6% to 33% of patients develop a local recurrence,4 which requires a different approach because it is not confined to one anatomical compartment due to distortion of the anatomical fascial borders as
result of the prior resection. Multimodality treatment of locally advanced primary rectal carcinoma and locally recurrent rectal carcinoma combining preoperative radiotherapy, extensive surgery, and intraoperative radiotherapy is the standard.5-7 Neoadjuvant therapy induces fibrosis, which adds to the difficulty of the extended tumor dissections. These procedures are often associated 1
St Elisabeth Hospital, Tilburg, Netherlands Delft University of Technology, Delft, Netherlands 3 Catharina Hospital, Eindhoven, Netherlands 4 Erasmus Medical Center, Rotterdam, Netherlands 2
Corresponding Author: Harm J. Rutten, Department of Surgery, Catharina Hospital, PO Box 1350, Eindhoven 5602 ZA, Netherlands. Email: [email protected]
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Figure 1. MRI images of a patient used for a 3D reconstruction of the pelvic cavity.
with major blood loss, often from bleeding from the presacral and lateral venous plexus. Median volumes of blood loss between 1.4 and 6.5 L have been published.8 Hemostasis can be difficult. This has resulted in the exploration of a large variety of hemostatic methods, such as sutures, cautery, thumbnails,9 hemostatic sponges and cyanoacrylate glue,10 Table Fixation Staples,11 synthetic hemostatic agents,12 or muscle fragments.13,14 One commonly used technique in massive bleeding from the presacral venous plexus is packing the pelvis with surgical gauzes, which achieves hemostasis by applying uncontrolled pressure on the pelvic cavity wall.15-17 An important advantage of packing with gauzes is the ability to fill up different shaped cavities. However, a big disadvantage of the surgical gauze is the adherence to the surrounding tissues. If the gauze is removed too early, rebleeding can occur, and if they are left in place too long, the risk of infection rises. Moreover, a second laparotomy is required to remove the gauzes in patients recovering from major surgery. In previous studies the use of an isolated bowel,16 breast implant,18,19 tissue expander,20 and saline bag21 have been described to provide enough pressure to tamponade the bleeding. However, these devices must be removed through the perineal wound and are therefore only suitable for abdomino-perineal procedures. Furthermore, the lack of pressure control, with the subsequent risk of tissue necrosis, complete venous obstruction, or occlusion of the ureters are serious disadvantages. Ideally, a hemostatic device would be able to achieve hemostasis in the rectal compartment. Another requirement would be that the device could be removed without the necessity to perform a second laparotomy. Secondary requirements are fast and easy positioning when a bleeding complication occurs, and easy removal without adherence to the cavity wall to avoid secondary bleeding. Also, the pressure applied on the surrounding tissue should be moderate to minimize the risk for necrosis or obstruction and finally the device has to adapt to the variable shape of the pelvic cavity.
We developed a promising technique to stop uncontrollable bleeding using a hemostatic balloon. In this article, we present the rationale behind the development of the first clinical usable prototype and the clinical experience in 9 patients.
Methods and Materials This study was undertaken at the Catharina Hospital Eindhoven, which is a national referral center for locally advanced and recurrent rectal cancer patients, in collaboration with the faculty of Industrial Design Engineering of Delft University of Technology.
Development of the Hemostatic Balloon Device To understand the shape of the rectal cavity and its variation, 3-dimensional (3D) models of the rectum, based on magnetic resonance imaging (MRI) scans, were made. The model and volume of the balloon was based on the form, shape, and volume of the rectum, because this shape would be able to provide equally divided pressure after the rectum was removed. The aim was to develop a model that was the same form of the cavity left after removal of the rectum. In case of an excenteration the elastic capacities of the model should provide enough room to create additional volume. By copying the contours of the rectum out of MRI scans (Figure 1), a 3D model was generated with the help of the 3D program SolidWorks 2005 (Figure 2). The device should be able to cover the entire wall of the pelvic cavity. Based on the geometric information found, 7 test balloons were developed using moulds and a 2-component silicon rubber. The models had different shapes and from 1 up to 4 different compartments to be filled separately. To evaluate the resulting pressure of the different geometries on the pelvic wall, a female cadaver model was created where a rectal resection was performed without amputation of the anus and pelvic floor muscles. An Oxford Pressure Monitor with 12 separated sensors was
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Figure 2. Three-dimensional reconstruction of the pelvic cavity in a male.
Figure 3. Pressure sensors on the wall of the pelvic cavity. The positioning of the numbered sensors (colored red) in the cavity is shown at the left side. Sensors 8 to 12 were placed at the presacral plexus.
used to measure the pressure applied to the walls of the cavity. Five sensors were placed at the presacral plexus (Figure 3). The pressure on the sensors was measured while the balloons were stepwise filled with saline adding 60 mL repeatedly. Eventually a balloon with 3 different compartments (Figure 4) had the best ability to apply the locally appropriate pressure, and this model was tested in a clinical setting. A positioning strip was use to place the device in the pelvic cavity, and it contained 3 different catheters for filling the 3 separate compartments.
Clinical Implementation of the Hemostatic Balloon Device The Hemostatic Balloon Device was placed in patients in whom during surgery for primary locally advanced or local recurrent rectal cancer uncontrollable bleeding from the venous presacral plexus occurred. The balloon was used after conventional measures failed to stop the bleeding. The decision to use the balloon was made the moment we previously would have decided to pack the pelvis with
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Figure 4. Pressure path of the internal pressure of the silicon balloon model and the pressure on the 11 sensors. A linear relation between internal pressure and volume also between external pressure and volume is shown.
gauzes. Demographic data as well as data about the volume of blood loss, type of surgery, moment of removal of the device, and efficacy of the device were collected.
Results Development of the Hemostatic Balloon Device The MRI scans of 7 female and 7 male patients were selected to measure the volumes of the pelvic cavity. During the development of the balloon, 2 different types of 3D computer models based on the MRI scans were made of every patient, a representation of the rectum and a representation of the rectal cavity. Data about the volumes of the models of the rectal cavities and the cavities after amputation of the rectum (containing a balloon) were collected. When analyzing the 3D rectum models, the volumes of the rectal cavity had a mean of 268 mL (±62 mL) and the cavities after an amputation had a mean volume of 359 mL (±76 mL). The range between the largest and smallest cavity volume was 306 mL. Because of the high interpatient variability, a material with high flexibility and elasticity was required to align the different shapes and volumes of the cavity. The internal pressure in the silicon model and the pressure on the pelvic wall itself are represented for the 3-compartment model (Figure 5). The 3 compartments can be filled with saline through separate catheters located inside the positioning strip. Separate compartments allow differences in the shape of the model and therefore selective higher pressures in different shaped
Figure 5. Model of the Hemostatic Rectal Cavity balloon.
cavities. Especially the lowest compartment caudal from the os coccygis contributed to fixation of the device. The internal pressure of the compartments reflects the pressure applied on the walls of the rectal cavity. The final design is presented in Figure 6.
Clinical Implementation of the Hemostatic Balloon Device In the period between June 2009 and July 2010, the balloon was used in 9 patients. Eight males and 1 female were included, and the median age of the patients was 65.2 years (range = 48-86). Surgery was performed for primary locally advanced rectal cancer (n = 4), recurrent rectal cancer
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because the bleeding had stopped. We found no complications of obstruction of the ureters, although most patients in our center receive preoperative splinting of the ureters preoperatively.
Discussion
Figure 6. The balloon after placement in the rectal cavity during uncontrollable bleeding from the venous presacral plexus.
(n = 4), and endometrial cancer (n = 1). All but 1 patient received long course neoadjuvant chemo-radiation. Median duration of the surgery was 282.5 minutes (range = 147-444). Median volume of blood loss was 7500 mL (range = 3000-11 000 mL). All patients received transfusion, and in 6 patients the Cell Saver was used. The median returned volume by the cell saver was 1400 mL (range = 500-2500). The 30-day mortality was 0%. The selected patients would otherwise have received packing due to profuse bleeding. The balloon was placed onto the bladder, prostate, or cervix and vagina (Figure 6). After achieving the right amount of pressure, the balloon was left in the pelvic cavity, the positioning strip left suprapubically through the abdominal wall, and the abdomen was closed. If there were no signs of active bleeding on the first postoperative day, some of the saline was removed to decrease the pressure. On the second day all the saline was removed, but the balloon was left in place so in case of repeated bleeding the compartments could be filled up. On the third day the balloon was removed through the laparotomy wound and the fascia was closed with sutures that were placed during the primary surgery. After a median number of 2 days the balloon was removed. In 6 patients the balloon was placed and removed later on the ward without anesthesia. In 1 patient the pelvic cavity was initially conventionally packed because of an uncontrollable bleeding. After 2 days a second laparotomy was performed to remove the gauzes and due to continuous bleeding a balloon was successfully placed. It was removed after 3 days. In 1 patient the balloon was placed and a relaparotomy was performed the same day because of persistent bleeding. It was found that the balloon was dislocated cranially and the pelvis was packed with surgical gauzes instead, which were removed 2 days later. In 1 patient the balloon was placed during surgery and removed during the same operation
We succeeded in developing a Hemostatic Rectal Cavity balloon to control excessive pelvic bleeding after extensive rectal surgery. A prototype successfully achieved hemostasis in 8 out of 9 patients, and it could be removed without the necessity to perform a second laparotomy in 7 patients without general anesthesia within a few days. Gauzes and tissue expanders on the other hand require an extra surgical procedure in a critically ill patient. Moreover, the pressure applied on the surrounding tissue by the balloon induced no necrosis or obstruction due to a linear relation of the volume of the balloon and the internal pressure in the balloon and the external pressure. From previous research we know that the minimum pressure has to exceed the value of 17.3 cm H2O (= 12.7 mm Hg), which is the mean venous pressure in the pelvic veins.22 The data presented in Figure 4 show the influence of the moment of contact between the balloon and the cavity wall. Because of the linear relationship between internal pressure and external pressure on the cavity wall, the internal pressure can be used to estimate when an adequate pressure is achieved. Also, the 3D balloon approached the anatomy of the pelvic cavity, which created a steady distribution of the pressure on the cavity wall. The advantage of a 3-compartment balloon is the possibility of applying different pressure to different areas in the pelvic cavity. This is an advantage that is not possible in all previously described hemostatic options. Furthermore, the most caudal compartment, which is localized below the os coccygis, worked as an anchor. The developed balloon is shown in Figure 5. The balloon and the positioning strip constitute the 2 most important parts of the device. The components are made out of a medical-grade silicone rubber, which has great elasticity properties of about 600%. The inert material will prevent the adherence of the balloon to surrounding tissue, which prevents disruption of previous clotting with the subsequent risk of rebleeding. The first clinical data on the use of the balloon showed promising results. The balloon was used after hemostatic agents failed. After using hemostatic agents the balloon was placed; however, the hemostatic agents where left in situ. The challenge was to develop a device that would not become adherent to surrounding structures because that could induce rebleeding after removal of the device. On the other hand, it was important that the device would not move. The shape of the different compartments should prevent displacement, and the most caudal compartment below the os coccyges functioned as an anchor.
302 However, in 1 patient the balloon displaced cranially, which led to an alteration in the procedure, namely, placement of a transperineal fixation suture. In the future, it may be possible to cover the balloon with a hemostatic agent. The balloon was easy to position, although it unfortunately was displaced in 1 patient. This observation has led to an alteration in the procedure and now a suture through the HRC and the perineum is placed to prevent dislocation. These first results are promising, and further research is needed to evaluate how effective the balloon is in controlling massive bleeding during rectal cancer surgery. Future perspectives include a possibly thinner silicon rubber that can be stretched more easily with a lower inflated volume.
Conclusion The hemostatic balloon is a new and promising technique for accomplishing hemostasis with controllable pressure on the pelvic cavity wall and can be removed without the need for a second laparotomy. Acknowledgement The hemostatic rectal cavity ballon was manufactured by Medanco B.V. (De Run 5213, 5504 DC Veldhoven,The Netherlands).
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References 1. Cunningham D, Atkin W, Lenz HJ, et al. Colorectal cancer. Lancet. 2010;375:1030-1047. 2. Nagtegaal ID, Quirke P. What is the role for the circumferential margin in the modern treatment of rectal cancer? J Clin Oncol. 2008;26:303-312. 3. Dresen RC, Peters EE, Rutten HJ, et al. Local recurrence in rectal cancer can be predicted by histopathological factors. Eur J Surg Oncol. 2009;35:1071-1077. 4. Kusters M, Holman FA, Martijn H, et al. Patterns of local recurrence in locally advanced rectal cancer after intraoperative radiotherapy containing multimodality treatment. Radiother Oncol. 2009;92:221-225. 5. Mannaerts GH, Martijn H, Crommelin MA, Dries W, Repelaer van Driel OJ, Rutten HJ. Feasibility and first results of multimodality treatment, combining EBRT, extensive surgery, and IOERT in locally advanced primary rectal cancer. Int J Radiat Oncol Biol Phys. 2000;47:425-433. 6. Mannaerts GH, Martijn H, Crommelin MA, et al. Intraoperative electron beam radiation therapy for locally
Surgical Innovation 21(3) recurrent rectal carcinoma. Int J Radiat Oncol Biol Phys. 1999;45:297-308. 7. Dresen RC, Gosens MJ, Martijn H, et al. Radical resection after IORT-containing multimodality treatment is the most important determinant for outcome in patients treated for locally recurrent rectal cancer. Ann Surg Oncol. 2008;15:1937-1947. 8. Mannaerts GH, Rutten HJ, Martijn H, Groen GJ, Hanssens PE, Wiggers T. Abdominosacral resection for primary irresectable and locally recurrent rectal cancer. Dis Colon Rectum. 2001;44:806-814. 9. van der Vurst TJ, Bodegom ME, Rakic S. Tamponade of presacral hemorrhage with hemostatic sponges fixed to the sacrum with endoscopic helical tackers: report of two cases. Dis Colon Rectum. 2004;47:1550-1553. 10. Losanoff JE, Richman BW, Jones JW. Cyanoacrylate adhesive in management of severe presacral bleeding. Dis Colon Rectum. 2002;45:1118-1119. 11. Wang LT, Feng CC, Wu CC, Hsiao CW, Weng PW, Jao SW. The use of table fixation staples to control massive presacral hemorrhage: a successful alternative treatment. Report of a case. Dis Colon Rectum. 2009;52:159-161. 12. Germanos S, Bolanis I, Saedon M, Baratsis S. Control of presacral venous bleeding during rectal surgery. Am J Surg. 2010;200:e33-e35. 13. Remzi FH, Oncel M, Fazio VW. Muscle tamponade to control presacral venous bleeding: report of two cases. Dis Colon Rectum. 2002;45:1109-1111. 14. Ayuste E Jr, Roxas MF. Validating the use of rectus muscle fragment welding to control presacral bleeding during rectal mobilization. Asian J Surg. 2004;27:18-21. 15. Finan MA, Fiorica JV, Hoffman MS, et al. Massive pelvic hemorrhage during gynecologic cancer surgery: “pack and go back.” Gynecol Oncol. 1996;62:390-395. 16. Metzger PP. Modified packing technique for control of presacral pelvic bleeding. Dis Colon Rectum. 1988;31:981-982. 17. Wydra D, Emerich J, Ciach K, Dudziak M, Marciniak A. Surgical pelvic packing as a means of controlling massive intraoperative bleeding during pelvic posterior exenteration—a case report and review of the literature. Int J Gynecol Cancer. 2004;14:1050-1054. 18. Braley SC, Schneider PD, Bold RJ, Goodnight JE Jr, Khatri VP. Controlled tamponade of severe presacral venous hemorrhage: use of a breast implant sizer. Dis Colon Rectum. 2002;45:140-142. 19. Chong CL, Tan NG, Chin FK, Ooi BS, Lim D. “Snowman” breast implant—an aid to pelvic haemostasis and adjuvant radiotherapy in pelvic surgery. J Obstet Gynaecol. 2010;30:421-423. 20. Cosman BC, Lackides GA, Fisher DP, Eskenazi LB. Use of tissue expander for tamponade of presacral hemorrhage. Report of a case. Dis Colon Rectum. 1994;37:723-726. 21. Ng X, Chiou W, Chang S. Controlling a presacral hemorrhage by using a saline bag: report of a case. Dis Colon Rectum. 2008;51:972-974. 22. Wang QY, Shi WJ, Zhao YR, Zhou WQ, He ZR. New concepts in severe presacral hemorrhage during proctectomy. Arch Surg. 1985;120:1013-1020.
research-article2013
SRIXXX10.1177/1553350613507145Surgical Innovation XX(X)Holman et al
Innovative Technologies
Development and Clinical Implementation of a Hemostatic Balloon Device for Rectal Cancer Surgery
Surgical Innovation 2014, Vol. 21(3) 297–302 © The Author(s) 2013 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1553350613507145 sri.sagepub.com
Fabian A. Holman, MD1, Noortje van der Pant, MSc2, Ignace H. J. T. de Hingh, MD, PhD3, Ingrid Martijnse, MD3, Jack Jakimowicz, MD, PhD3, Harm J. Rutten, MD, PhD, FRCS3, and Richard H. M. Goossens, MSc, PhD2,4
Abstract Background. Surgery for locally advanced and recurrent rectal carcinoma can be associated with major blood loss. Objective. We developed a promising technique using a hemostatic balloon to stop uncontrollable bleeding. Design. Models were developed using pelvic magnetic resonance imaging scans, and these models were tested in a cadaveric study. Eventually a model was tested in a clinical setting. The Hemostatic Balloon Device was placed in patients in whom during surgery uncontrollable bleeding from the venous presacral plexus occurred. Settings. A tertiary referral hospital for locally advanced and recurrent rectal cancer. Patients. Patients receiving multimodality treatment for primary or recurrent locally advanced rectal carcinomas. Main Outcome Measures. First the developed prototypes were tested in a cadaveric study where the developing pressure on the pelvic wall was measured. Second, the Hemostatic Balloon Device was placed in patients in whom during surgery uncontrollable bleeding from the venous presacral plexus occurred. Results. The balloon was used in 9 patients. Median volume of blood loss was 7500 mL. In 8 patients treatment with the hemostatic balloon was successful. In 1 patient the balloon was dislocated cranially and the pelvis was packed with surgical gauzes. Limitations. These first results are promising but further research is needed to evaluate how effective the balloon is in controlling massive bleeding during rectal cancer surgery. Future perspectives include a possibly thinner silicon rubber that can be stretched more easily with a lower inflated volume. Discussion. The hemostatic balloon is a new and promising technique for accomplishing hemostasis with controllable pressure on the pelvic cavity wall and can be removed without the need for a second laparotomy. Keywords colorectal surgery, surgical oncology, surgical education
Introduction Colorectal cancer has a current worldwide incidence of more than 1 million new cases.1 Of all colorectal tumors, 30% is situated in the rectum. Rectal cancer constitutes a different entity in the colorectal cancer group, because the rectum has a closer relation to the surrounding tissues. Of all rectal cancer patients, 75% have a mobile tumor and 25% present themselves with a tumor extending into or beyond the enveloping mesorectal fascia. Free circumferential resection margins is one of the most important prognostic variables for oncological outcome for rectal cancer.2,3 After resection, 6% to 33% of patients develop a local recurrence,4 which requires a different approach because it is not confined to one anatomical compartment due to distortion of the anatomical fascial borders as
result of the prior resection. Multimodality treatment of locally advanced primary rectal carcinoma and locally recurrent rectal carcinoma combining preoperative radiotherapy, extensive surgery, and intraoperative radiotherapy is the standard.5-7 Neoadjuvant therapy induces fibrosis, which adds to the difficulty of the extended tumor dissections. These procedures are often associated 1
St Elisabeth Hospital, Tilburg, Netherlands Delft University of Technology, Delft, Netherlands 3 Catharina Hospital, Eindhoven, Netherlands 4 Erasmus Medical Center, Rotterdam, Netherlands 2
Corresponding Author: Harm J. Rutten, Department of Surgery, Catharina Hospital, PO Box 1350, Eindhoven 5602 ZA, Netherlands. Email: [email protected]
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Figure 1. MRI images of a patient used for a 3D reconstruction of the pelvic cavity.
with major blood loss, often from bleeding from the presacral and lateral venous plexus. Median volumes of blood loss between 1.4 and 6.5 L have been published.8 Hemostasis can be difficult. This has resulted in the exploration of a large variety of hemostatic methods, such as sutures, cautery, thumbnails,9 hemostatic sponges and cyanoacrylate glue,10 Table Fixation Staples,11 synthetic hemostatic agents,12 or muscle fragments.13,14 One commonly used technique in massive bleeding from the presacral venous plexus is packing the pelvis with surgical gauzes, which achieves hemostasis by applying uncontrolled pressure on the pelvic cavity wall.15-17 An important advantage of packing with gauzes is the ability to fill up different shaped cavities. However, a big disadvantage of the surgical gauze is the adherence to the surrounding tissues. If the gauze is removed too early, rebleeding can occur, and if they are left in place too long, the risk of infection rises. Moreover, a second laparotomy is required to remove the gauzes in patients recovering from major surgery. In previous studies the use of an isolated bowel,16 breast implant,18,19 tissue expander,20 and saline bag21 have been described to provide enough pressure to tamponade the bleeding. However, these devices must be removed through the perineal wound and are therefore only suitable for abdomino-perineal procedures. Furthermore, the lack of pressure control, with the subsequent risk of tissue necrosis, complete venous obstruction, or occlusion of the ureters are serious disadvantages. Ideally, a hemostatic device would be able to achieve hemostasis in the rectal compartment. Another requirement would be that the device could be removed without the necessity to perform a second laparotomy. Secondary requirements are fast and easy positioning when a bleeding complication occurs, and easy removal without adherence to the cavity wall to avoid secondary bleeding. Also, the pressure applied on the surrounding tissue should be moderate to minimize the risk for necrosis or obstruction and finally the device has to adapt to the variable shape of the pelvic cavity.
We developed a promising technique to stop uncontrollable bleeding using a hemostatic balloon. In this article, we present the rationale behind the development of the first clinical usable prototype and the clinical experience in 9 patients.
Methods and Materials This study was undertaken at the Catharina Hospital Eindhoven, which is a national referral center for locally advanced and recurrent rectal cancer patients, in collaboration with the faculty of Industrial Design Engineering of Delft University of Technology.
Development of the Hemostatic Balloon Device To understand the shape of the rectal cavity and its variation, 3-dimensional (3D) models of the rectum, based on magnetic resonance imaging (MRI) scans, were made. The model and volume of the balloon was based on the form, shape, and volume of the rectum, because this shape would be able to provide equally divided pressure after the rectum was removed. The aim was to develop a model that was the same form of the cavity left after removal of the rectum. In case of an excenteration the elastic capacities of the model should provide enough room to create additional volume. By copying the contours of the rectum out of MRI scans (Figure 1), a 3D model was generated with the help of the 3D program SolidWorks 2005 (Figure 2). The device should be able to cover the entire wall of the pelvic cavity. Based on the geometric information found, 7 test balloons were developed using moulds and a 2-component silicon rubber. The models had different shapes and from 1 up to 4 different compartments to be filled separately. To evaluate the resulting pressure of the different geometries on the pelvic wall, a female cadaver model was created where a rectal resection was performed without amputation of the anus and pelvic floor muscles. An Oxford Pressure Monitor with 12 separated sensors was
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Figure 2. Three-dimensional reconstruction of the pelvic cavity in a male.
Figure 3. Pressure sensors on the wall of the pelvic cavity. The positioning of the numbered sensors (colored red) in the cavity is shown at the left side. Sensors 8 to 12 were placed at the presacral plexus.
used to measure the pressure applied to the walls of the cavity. Five sensors were placed at the presacral plexus (Figure 3). The pressure on the sensors was measured while the balloons were stepwise filled with saline adding 60 mL repeatedly. Eventually a balloon with 3 different compartments (Figure 4) had the best ability to apply the locally appropriate pressure, and this model was tested in a clinical setting. A positioning strip was use to place the device in the pelvic cavity, and it contained 3 different catheters for filling the 3 separate compartments.
Clinical Implementation of the Hemostatic Balloon Device The Hemostatic Balloon Device was placed in patients in whom during surgery for primary locally advanced or local recurrent rectal cancer uncontrollable bleeding from the venous presacral plexus occurred. The balloon was used after conventional measures failed to stop the bleeding. The decision to use the balloon was made the moment we previously would have decided to pack the pelvis with
300
Surgical Innovation 21(3)
Figure 4. Pressure path of the internal pressure of the silicon balloon model and the pressure on the 11 sensors. A linear relation between internal pressure and volume also between external pressure and volume is shown.
gauzes. Demographic data as well as data about the volume of blood loss, type of surgery, moment of removal of the device, and efficacy of the device were collected.
Results Development of the Hemostatic Balloon Device The MRI scans of 7 female and 7 male patients were selected to measure the volumes of the pelvic cavity. During the development of the balloon, 2 different types of 3D computer models based on the MRI scans were made of every patient, a representation of the rectum and a representation of the rectal cavity. Data about the volumes of the models of the rectal cavities and the cavities after amputation of the rectum (containing a balloon) were collected. When analyzing the 3D rectum models, the volumes of the rectal cavity had a mean of 268 mL (±62 mL) and the cavities after an amputation had a mean volume of 359 mL (±76 mL). The range between the largest and smallest cavity volume was 306 mL. Because of the high interpatient variability, a material with high flexibility and elasticity was required to align the different shapes and volumes of the cavity. The internal pressure in the silicon model and the pressure on the pelvic wall itself are represented for the 3-compartment model (Figure 5). The 3 compartments can be filled with saline through separate catheters located inside the positioning strip. Separate compartments allow differences in the shape of the model and therefore selective higher pressures in different shaped
Figure 5. Model of the Hemostatic Rectal Cavity balloon.
cavities. Especially the lowest compartment caudal from the os coccygis contributed to fixation of the device. The internal pressure of the compartments reflects the pressure applied on the walls of the rectal cavity. The final design is presented in Figure 6.
Clinical Implementation of the Hemostatic Balloon Device In the period between June 2009 and July 2010, the balloon was used in 9 patients. Eight males and 1 female were included, and the median age of the patients was 65.2 years (range = 48-86). Surgery was performed for primary locally advanced rectal cancer (n = 4), recurrent rectal cancer
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Holman et al
because the bleeding had stopped. We found no complications of obstruction of the ureters, although most patients in our center receive preoperative splinting of the ureters preoperatively.
Discussion
Figure 6. The balloon after placement in the rectal cavity during uncontrollable bleeding from the venous presacral plexus.
(n = 4), and endometrial cancer (n = 1). All but 1 patient received long course neoadjuvant chemo-radiation. Median duration of the surgery was 282.5 minutes (range = 147-444). Median volume of blood loss was 7500 mL (range = 3000-11 000 mL). All patients received transfusion, and in 6 patients the Cell Saver was used. The median returned volume by the cell saver was 1400 mL (range = 500-2500). The 30-day mortality was 0%. The selected patients would otherwise have received packing due to profuse bleeding. The balloon was placed onto the bladder, prostate, or cervix and vagina (Figure 6). After achieving the right amount of pressure, the balloon was left in the pelvic cavity, the positioning strip left suprapubically through the abdominal wall, and the abdomen was closed. If there were no signs of active bleeding on the first postoperative day, some of the saline was removed to decrease the pressure. On the second day all the saline was removed, but the balloon was left in place so in case of repeated bleeding the compartments could be filled up. On the third day the balloon was removed through the laparotomy wound and the fascia was closed with sutures that were placed during the primary surgery. After a median number of 2 days the balloon was removed. In 6 patients the balloon was placed and removed later on the ward without anesthesia. In 1 patient the pelvic cavity was initially conventionally packed because of an uncontrollable bleeding. After 2 days a second laparotomy was performed to remove the gauzes and due to continuous bleeding a balloon was successfully placed. It was removed after 3 days. In 1 patient the balloon was placed and a relaparotomy was performed the same day because of persistent bleeding. It was found that the balloon was dislocated cranially and the pelvis was packed with surgical gauzes instead, which were removed 2 days later. In 1 patient the balloon was placed during surgery and removed during the same operation
We succeeded in developing a Hemostatic Rectal Cavity balloon to control excessive pelvic bleeding after extensive rectal surgery. A prototype successfully achieved hemostasis in 8 out of 9 patients, and it could be removed without the necessity to perform a second laparotomy in 7 patients without general anesthesia within a few days. Gauzes and tissue expanders on the other hand require an extra surgical procedure in a critically ill patient. Moreover, the pressure applied on the surrounding tissue by the balloon induced no necrosis or obstruction due to a linear relation of the volume of the balloon and the internal pressure in the balloon and the external pressure. From previous research we know that the minimum pressure has to exceed the value of 17.3 cm H2O (= 12.7 mm Hg), which is the mean venous pressure in the pelvic veins.22 The data presented in Figure 4 show the influence of the moment of contact between the balloon and the cavity wall. Because of the linear relationship between internal pressure and external pressure on the cavity wall, the internal pressure can be used to estimate when an adequate pressure is achieved. Also, the 3D balloon approached the anatomy of the pelvic cavity, which created a steady distribution of the pressure on the cavity wall. The advantage of a 3-compartment balloon is the possibility of applying different pressure to different areas in the pelvic cavity. This is an advantage that is not possible in all previously described hemostatic options. Furthermore, the most caudal compartment, which is localized below the os coccygis, worked as an anchor. The developed balloon is shown in Figure 5. The balloon and the positioning strip constitute the 2 most important parts of the device. The components are made out of a medical-grade silicone rubber, which has great elasticity properties of about 600%. The inert material will prevent the adherence of the balloon to surrounding tissue, which prevents disruption of previous clotting with the subsequent risk of rebleeding. The first clinical data on the use of the balloon showed promising results. The balloon was used after hemostatic agents failed. After using hemostatic agents the balloon was placed; however, the hemostatic agents where left in situ. The challenge was to develop a device that would not become adherent to surrounding structures because that could induce rebleeding after removal of the device. On the other hand, it was important that the device would not move. The shape of the different compartments should prevent displacement, and the most caudal compartment below the os coccyges functioned as an anchor.
302 However, in 1 patient the balloon displaced cranially, which led to an alteration in the procedure, namely, placement of a transperineal fixation suture. In the future, it may be possible to cover the balloon with a hemostatic agent. The balloon was easy to position, although it unfortunately was displaced in 1 patient. This observation has led to an alteration in the procedure and now a suture through the HRC and the perineum is placed to prevent dislocation. These first results are promising, and further research is needed to evaluate how effective the balloon is in controlling massive bleeding during rectal cancer surgery. Future perspectives include a possibly thinner silicon rubber that can be stretched more easily with a lower inflated volume.
Conclusion The hemostatic balloon is a new and promising technique for accomplishing hemostasis with controllable pressure on the pelvic cavity wall and can be removed without the need for a second laparotomy. Acknowledgement The hemostatic rectal cavity ballon was manufactured by Medanco B.V. (De Run 5213, 5504 DC Veldhoven,The Netherlands).
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
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