Prospective Randomized Comparison of Clinical Results of Hand Assisted Laparoscopic Splenectomies and Open Splenectomies
Prospective Randomized Comparison of Clinical Results of Hand Assisted Laparoscopic Splenectomies and Open Splenectomies
ABSTRACT

 Background: Although there are some comparative studies between laparoscopy and hand-assisted
 laparoscopic splenectomy (HALS) in splenomegaly cases, there is no study of the differences
 between HALS and open splenectomy (OS). Our aim was to compare the HALS and OS techniques in
 splenomegaly cases.

 Methods: This prospective study included 27 patients undergoing splenectomy for splenic
 disorders at the Department of General Surgery, Istanbul Medical Faculty between February
 2007 and October 2007. OS was performed on 14 patients, and HALS was performed in the other
 13 patients.

 Key words: HALS, open splenectomy, splenomegaly
The advent of laparoscopic surgery, increasing experience in its performance and advances in
 techniques and surgical devices have all greatly influenced general surgery. The usefulness
 of laparoscopic surgery has already been well proven in cholecystectomy, esophageal
 antireflux surgery, and splenectomy for benign diseases (1). Laparoscopy is also now gaining
 recognition for procedures accompanied by lymph node dissection, such as gastric and
 colorectal surgery (2, 3). The development of hand-assisted laparoscopic surgery (HALS) has
 also brought about improvements in regard to various disadvantages that have previously been
 associated with laparoscopic surgery, including lack of tactile sensation feedback, poor
 depth perception, lack of quick access in the event of unexpected hemorrhage, and
 difficulties with intracorporal suturing. Such improvements have enabled the performance of
 advanced laparoscopic surgery (4).

 To solve the problems associated with a long learning curve and long operating times, hand
 ports have been introduced. Through the hand port, the surgeon's hand can be introduced into
 the abdomen while the pneumoperitoneum is preserved. The use of a hand port reduces operating
 time and shortens the learning curve (5). It has already been suggested that procedures
 requiring an incision to remove a specimen or organ are most suitable for HALS (6).

 Laparoscopic splenectomy (LS) for the normal-sized spleen has been shown to be a safe
 procedure, resulting in short hospital stays, low postoperative pain scores, technical
 hurdles and, as a result, can be more difficult. LS has advantages over open splenectomy (7),
 and it is now considered by many surgeons to be the procedure of choice for normal-sized
 spleens. Splenectomy for giant spleens using solely laparoscopic approaches is feasible, but
 it can be time consuming and challenging to any surgeon despite his or her high level of
 experience with laparoscopy.

 With increased splenic sizes, LS becomes more technically challenging, although the procedure
 is still feasible (8,5). Hand-assisted laparoscopic technique allows the surgeon to place one
 hand into the abdominal cavity while maintaining the pneumoperitoneum, recovering tactile
 sense and improving the accuracy of manipulation. This has been verified in various
 complicated laparoscopic procedures, including colectomies, nephrectomies, and hepatectomies.
 Based on these experiences, HALS may be well suited for the removal of splenomegaly when the
 final spleen weight is greater than 500 g (9).

 It would be of interest to assess whether outcomes of the HALS hybrid technique approximate
 those obtained with laparoscopy or with the open approach. Since comparative studies between
 laparoscopy and HALS have been already carried out, we compared open splenectomy with HALS
 for splenomegaly cases. To our knowledge, this is the first prospective study to compare the
 results of HALS and OS.

 MATERIALS AND METHODS

 This prospective study included 27 patients undergoing splenectomy for splenic disorders at
 the Department of General Surgery, Istanbul Medical Faculty between February 2007 and October
 2007. Patients were selected randomly according to numbers on a random table and assigned to
 one of the two different surgical procedures. Twenty-seven patients with splenomegaly and
 primary splenic tumors were included in the study. The patients were divided into two groups
 according to the surgical procedure performed: open splenectomy (Group 1 :OS, n=14) and
 hand-assisted laparoscopic splenectomy (Group 2:HALS, n=13). The study plan was reviewed and
 approved by our institutional ethical committee, and informed consent was obtained for all
 patients.

 Non-Hodgkin lymphomas (n=11) were the main indication for splenectomy in this study. There
 were also rarely encountered primary splenic hemangiomas (n=2) (Table 1). Splenomegaly was
 identified clinically by palpation of the spleen below the coastal margin and/or by
 radiological examination of computerized tomography (CT) scans (15 cm or longer in
 craniocaudal diameter), with final intact splenic weight ≥ 500 g.

 The study parameters included age, sex, the greatest splenic diameter, preoperative platelet
 count, preoperative hematocrit level and postoperative diagnosis. Body Mass Index (BMI) was
 calculated as the ratio of weight (kg) divided by height squared (m2). All the patients were
 evaluated with the American Society of Anesthesiology (ASA) score (10). Operative data
 included operative time as measured from first skin incision to the application of dressings,
 intraoperative blood loss, splenic weight after intact removal, conversion, pain score, and
 postoperative length of hospital stay. Complications were classified as intraoperative or
 postoperative. The pain of all patients was scored during postoperative days. The visual
 analogue scale defined by Wewers (11) was used for the evaluation of the degree of pain.

 All the patients were vaccinated against pneumococci with Pneumovax 23 (Merck & Co Inc.,
 Whitehouse Station, NJ, USA) two weeks before the operation. All patients received antibiotic
 prophylaxis (Sulbactam and ampicillin 1 g, intravenously). All patients received general
 anesthesia during surgery and a standardized analgesic regimen. HALS and OS were performed by
 the same surgical team. Post-operative analgesia was achieved by patient-controlled analgesia
 via a pump containing a standard narcotic analgesic solution. All patients received the same
 non-steroidal antinflammatory drug (lornoxicam 8 mg, twice a day, intravenously) and the same
 narcotic analgesic (pethidine 50 mg, twice a day, intramuscularly) on the first and second
 postoperative day.

 Surgery Open Surgery(Group 1) Patients were placed in supine position. Since all patients had
 splenomegaly, preferred incisions were left subcostal. Only three patients requiring
 synchronous cholecystectomy had upper midline laparotomy incisions (18 cm, 18 cm and 20 cm in
 length). After routine whole abdominal exploration, with the assistance of abdominal
 retractors and the first assistance, the inferior pole and medial splenogastric ligament were
 dissected first, and then the splenorenal ligament and superior pole of the splenophrenic
 ligament were dissected. The LigaSure vessel sealing system (Valleylab division of Tyco
 Healthcare, Mansfield, MA) was used for the majority of the dissection. After this, the
 splenic vascular pedicule was separated from the pancreatic tail with careful dissection. In
 splenomegaly cases, if the splenic and perisplenic anatomy was appropriate, the ideal
 ligation of the splenic hilum was outside the abdomen (Figure 1). The splenic artery and
 splenic vein were ligated with silk (00) and sectioned. In the cases of massive splenomegaly,
 the main truncus of the splenic artery was ligated before the dissection to minimize blood
 loss and to allow the return of blood inside the spleen back to the circulation.

 Figure 1- Splenic hilum ligation outside of the abdominal cavity

 After the removal of the spleen, hemostasis was rechecked, and an aspirative drain was
 routinely placed. The abdominal wall was closed with loop polydioxanone (no: 1) in two layers
 with running sutures.

 HALS procedure(Group 2) Patients were placed in a semilateral position with the left side
 elevated 30˚. The surgeon stood on the patients' right side with the camera operator. First,
 a hand port incision was made in the upper midline (Figure 2). The incision measured 7-8 cm
 (depending on the size of the surgeon's glove) in all cases. Then, the hand-assisted device
 Omniport (Advanced Surgical Concepts, Co. Wicklow, Ireland) was installed.

 Figure 2- Omniport placed through an 8 cm upper midline incision in the HALS technique

 The surgeon's left (non-dominant) hand was placed into the abdominal cavity through the
 device. The 10-mm 30˚ laparoscope was placed at the inferior or superior crease of the
 umbilicus depending on the spleen size and location. The 10-mm main operating port was in the
 midclavicular line at the level of the umbilicus. Carbon dioxide was insufflated continuously
 with 13 mmHg for constant pneumoperitoneum. An intraabdominal exploration for accessory
 spleen was the first step. LigaSure was used as above. With the assistance of the
 intraabdominal hand, the inferior pole and medial splenogastric ligament were dissected
 first, and then the splenorenal ligament and superior pole of the splenophrenic ligament were
 dissected. Then, the splenic vascular pedicule was separated from the pancreatic tail by
 finger dissection. The splenic artery and splenic vein were either ligated with LigaSure or
 silk (00) and sectioned or dissected with an endo vascular stapler (Endo-GIA).

 In the cases of massive splenomegaly, the splenic artery was ligated before the dissection to
 gain enough operative space; this was also the case for LS. Finally, the spleen was placed
 into a retrieval bag and extracted intact via the hand port incision. Routinely, a suction
 drain was placed in the splenic fossa.

 Statistical analysis Data are reported as the mean ± SD. The analysis was performed with the
 statistical package SPSS 10.1 (SPSS, Chicago, IL). Differences between variables were
 compared with nonparametric Mann Whitney-U and Student's t and chi-square tests. Spearman
 correlation analysis was performed for all patients. Results were considered statistically
 significant when the two-tailed p value was less than 0.05.

 DISCUSSION

 In 1991, Delaitre et al. attempted the first laparoscopic LS (12). Since then, the
 laparoscopic approach for splenectomy has gained wide acceptance and has been shown by
 several groups to be a technically successful, safe, and effective procedure. LS is now
 considered the standard approach to removing a normal-sized spleen for patients without other
 contraindications. In cases of splenomegaly, LS is also feasible in experienced hands, but,
 because the larger-sized spleen makes the operative space narrow, the exposure is limited,
 and manipulations are difficult, the LS procedure becomes more technically challenging. The
 hypervascularization and dense adhesions around the spleen hamper the surgeon's performance
 as well. Moreover, once the dissection is completed, the extraction of a giant spleen with a
 solely laparoscopic approach by placing it into a retrieval bag followed by morcellation can
 be difficult, and it can add considerable time to the procedure.

 Some studies have suggested that LS for splenomegaly was associated with longer operation
 times, more blood loss, and higher intraoperative and postoperative complication rates than
 LS for normal-sized spleens (13). In addition, in some cases of splenomegaly, conversion is
 inevitable because of a requirement for an intact specimen for pathologic examination or
 because of serious hypervascularization and dense adhesion as the result of massive size (14,
 15). Targarona et al. (14) indicated that the conversion rate was correlated with the spleen
 weight: for spleens weighing 400 - 1000 g, it was 0, but it rose to 25% for weights > 1000 g
 and to 75% for weights > 3000 g. In their LS group, conversions to laparoscopy-assisted
 splenectomy occurred in four patients (25%), including one case (spleen weight of 1600 g) for
 which pathologic examination determined a sarcoma and three cases of complicated procedures
 due to spleen weight > 3000 g (16). The median splenic weight in our HALS group was 800
 (480-2110)g; we did not have any conversion to OS.
Inclusion Criteria:

 -  Splenomegaly 15 cm or longer spleens

 -  Patient confirmation to join the study

 Exclusion Criteria:

 -  Normal sized spleens

 -  Patient denial