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Assessment of Ports Site Complications in Laparoscopic Surgery

1 Dr. Ameer Abbas Sarheed and 2*Dr. Abdulrazzaq Kalaf Hassan

1Karbala University-College of Medicine, Karbala, Iraq

2 University of Al-Ameed - College of Medicine,Karbala, Iraq

*Correspondence to Prof. Dr. Abdul razzaq kalaf hassan ABSTRACT

Background: Laparoscopic surgery is a minimally access technique that has revolutionized the approach to surgery over the last three decades. It involves the use of reusable or disposable trocars and ports inserted through small skin incisions.

Throughout the worldwide acceptance and success of laparoscopic surgical procedures; tremendous research activities have been taken place to invent safe, cost effective, fine and reliable laparoscopic instruments namely trocars and ports. These delicate tools have minimized the complications may occur during surgery.

Aims of the study: This prospective analytic study was designed to determine the morbidity associated with ports at the site of their insertion in laparoscopic surgery. It has also emphasized the way of prevention of these complications and identified the risk factors causing these complications.

Patients and method: This is a prospective analytic study conducted at Al-Imam Al- Hussein medical city and Al-Safeer surgical hospital in Kerbala governorate during the period from 1st of February to the 31st of December 2019. In this series 220 patients included were admitted to the general surgical ward in these two hospitals for different laparoscopic procedures. Ports site were monitored for complications prospectively for 3 months. Those were converted to open procedures and those with immune compromised disease were excluded from the study.

Results: A series of 220 patients including 41(18.7%) males and 179(81.3%) females were operated. A total of 38 (17.27%) patients had ports site complications.

Laparoscopic cholecystectomy was the most commonly performed procedure (71.8%

n=158) with highest ports site complications (15% n=33). 28(12.7%) were due to ports site pain.12(5.4%) patients developed ports site infection. Five (2.2%) patients developed ports site heamatoma and two (0.9%) patients developed ports site bleeding. Ports site complications were common in the obese patients and increase with age and with increase ports numbers and sizes.

Conclusions: Ports site complications is important part of laparoscopic morbidity.

Most of the complications are avoidable when using perfect surgical technics and skills. Ports site pain is the most frequent and important post-operative complications.

INTRODUCTION

Rapid development in health care technology have been given the surgeon the power of not only treating diseases surgically but also minimizing surgical invasiveness. The best example is minimal access surgery MAS, which has caused a paradigm shift in the approach to modern surgery, by limiting the access related morbidities (1). MAS is a product of modern technology and surgical innovation that aims to accomplish surgical therapeutic goals with minimal somatic and psychological trauma (2).

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The extent of MAS is a wide spectrum and including in many surgical fields e.g., endoscopy, laparoscopy, arthroscopy, endovascular catheterization, etc. Such surgery includes the use of both hand-held and tele operated/tele manipulated (robot assisted/tele robotics) equipment, such as the da Vinci® Surgical System (3). Minimal access surgery has improved patient care by decreasing pain, shortening hospital stays, offering a faster recovery time, reduced metabolic response to injury and much smaller scars. In fact, the surgical procedure is much shorter than standard procedures and offers less chance of infection and other complications.

These laparoscopic procedures are proving popular with the patient. During minimally access procedures in many operations the procedure requires body access devices, which are utilized to introduce visualization equipment and operative instruments rather than a standard incision to access a required part of the body.

Nonparallel instrumentation is necessary to create a “depth of field” (3-dimensional vision) and introduce a variety of instrumentation. This concept is commonly known as triangulation (4).

Minimally access (mainly laparoscopic) surgery became a major part of general surgery with the introduction of laparoscopic cholecystectomy in the late 1980s. This was the culmination of the development of instruments and techniques by many physicians; Kelling developing pneumoperitoneum, Zollikofer using carbon dioxide, Kalk designing a lens system and the dual-trochar technique, Veress using the Veress needle to create pneumoperitoneum, Hasson developing the Hasson's trochar. At the present time, minimal access surgery has become the most important part of general surgery (5).

Laparoscopic surgery which is a part from MAS involves the use of reusable metallic or disposable plastic trocars inserted through small skin incisions or ports made on the skin with different sizes (3,5,10,12,15) mm (1). This ports form the portal of entry to perform the surgical procedure by means of specially devised instruments and telescope (6). It has gained popularity due to better aesthesis, lesser pain, early ambulation and discharge from the hospital with early return to work, minimizing the financial burden to the patient (7). Ever since Philips Mouret reported the first laparoscopic cholecystectomy in 1987, the approach has been adopted for many other surgical procedures including appendectomy, herniorrhaphy, colonic surgery, gastric surgery, urological and gynaecological surgery. This is because of the combination of advancement in technology with the increasing acceptance of MAS by patients, which has led to the expansion of the horizon of Laparoscopic surgery (8).

Gynecologists have been using laparoscopy for evaluating pelvic pathology and performing minor procedure like tube ligation for many years. However, most general surgeons did not recognize its value till the successful performance of laparoscopic cholecystectomy by Phylip Mouret (1987) and Francois Dubois and Jacques Perisant (1988) (9). The subsequent enthusiasm and worldwide acceptance of this procedure with its advantages of minimal patient's discomfort, short hospital stay and excellent cosmetic results has revolutionized the management of cholelithiasis. The success of laparoscopic cholecystectomy has stimulated interest in minimally access surgery and various centers are performing other surgical procedures like appendectomy, splenectomy, nephrectomy, hernia repair, vagotomy, fundoplication, Heller's oesophagomyotomy, Ramstedt's pyloromyotomy, small and large bowel resection and anterior rectal resection (10).

Several types of trocars both disposable and non-disposable are available. Maximum care is required during passage of the first trocar to prevent injury as the subsequent ones can be introduced under laparoscopic vision (11).

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The ability to establish pneumoperitoneum has long been regarded as the integral first step to any successful laparoscopic procedure. Direct trocar insertion (DTI) is one of the safe and an effective alternative to Veress needle insertion, Open access (Hasson’s technique) and Visual entry systems (disposable Optic trocars and Endotip visual cannula) in laparoscopic surgery for creating pneumoperitoneum.

Pneumoperitoneum is prerequisite in all laparoscopic procedures as it increases the distance between anterior abdominal wall and intra-abdominal viscera, thus creating a working space, most of the complications occur at the time of performing pneumoperitoneum (12). Various techniques used to create pneumoperitoneum are insertion of Veress needle, open laparoscopy involving opening of the peritoneum under direct vision (Hasson’s method), Optical trocar insertion and Direct trocar insertion (DTI) as well as variants of these techniques (13).

Despite proper surgical education and performance, complications can occur in all of these methods. Despite the belief that using a Veress needle is safer in performing pneumoperitoneum, several complications were reported, such as injury to vessels of the anterior abdominal wall, injury to pelvic and large retroperitoneal vessels, perforation and/or insufflation of bowel, gas embolism, subcutaneous or sub fascial insufflation (12).

Open access as described by Hasson in 1971 has shown to minimize vascular injuries but does not reduce bowel injury (14). Also open access is complicated by gas leak and port instability. Dingfelder, in 1978 was the first to publish on direct entry into the abdomen with a trocar. The suggested advantages of this method of entry are the avoidance of complications related to the use of the Veress needle such as failed pneumoperitoneum, preperitoneal insufflation, intestinal insufflation, or the more serious CO2 embolism. Direct trocar insertion, although a blind procedure, reduces the number of “blind steps” from three with Veress needle (insertion, insufflation, and trocar introduction) to just one, that of trocar introduction. It is fast as it is a one-step pneumoperitoneum (15). Byron et al preferred Direct trocar insertion technique for trocar placement because it had fewer minor complications and less operating time

(16). The umbilicus usually is selected as the preferred point of access because in this location the abdominal wall is quite thin, even in obese patients (17).

The common Complications of laparoscopic surgery are:

A) Port site and entrance complications:

1) Ports site bleeding.

2) ports site infection.

3) ports site hematoma.

4) Ports site hernia.

5) Ports site metastasis.

6) Hollow viscus perforation 7) Solid viscus injury

8) Blood vessel injury – hemorrhage

9) Subcutaneous emphysema. pneumothorax, pneumomediastinum B) Other complications

1) Biliary leakage 2) Gas embolism

3) Cardiorespiratory embarrassment due to elevation of diaphragm, compression of inferior vena cava.

4) Flash burn during electrocoagulation

5) CO2 absorptions with rise in the arterial CO2 6) Cardiac arrhythmias and cardiac; arrest

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7) Danger of transmission of diseases like hepatitis and AIDS (9).

The overall rate of major complications following a laparoscopic procedure is approximately 1.4 per 1,000 procedures (18). However, the incidence of ports site complications following laparoscopic surgery is considered to be around 21 per 100,000 cases and it has shown a proportional rise with the increase in size of the port site incision and trocar (19).

The overall complications/injuries that occur following laparoscopic surgeries involve, gastrointestinal (0.6 per 1,000), genitourinary (0.3 per 1000), vascular (0.1 per 1,000), and omentum (0.4 per 1,000). However, the rarer complications include pyoderma gangrenosum, metastasis at the port site following laparoscopic oncosurgery, and port site infections (PSIs) (20).

With the widespread acceptance of laparoscopic surgical procedures tremendous research activity is taking place throughout the world for development of more and more effective and user friendly instruments and the coming years may see many revolutionary innovations (5).

Aims of the study

This prospective analytic study was designed to;

*Determine the complications associated with ports at the site of their insertion in laparoscopic surgery.

*The way of prevention of these complications.

*Identified the risk factors causing these complications.

PATIENTS AND METHOD

This is a prospective observational study conducted at Al-Imam Al-Hussein medical city and Al-Safeer surgical hospital in Kerala governorate during the period from 1st of February to the 31st of December 2019. 220 patients included in the study were admitted to the general surgical ward in these two hospitals for different laparoscopic procedures. Ports site were monitored for complications prospectively. Those were converted to open procedures and those with immune compromised disease were excluded from the study.

All the patients had full preoperative workup of the primary surgical condition and other medical problems and risk factors for general anaesthesia and surgical complications. General anaesthesia was given with endotracheal intubation, the patients were observed for any ports site complications during operation and in the postoperative period till three months after operation.

In our study (110) patients received antibiotics preoperatively (with induction) and another (110) did not receive antibiotics (randomly). Veress needle, open techniques and blind entrance were used to create pneumoperitoneum using 5, 10 & 12 mm trocars depending upon type of operation. Reusable and disposable ports were used according to the type of surgery. We use reusable ports after wash then sterilization with formalin.

Once the surgery was finished, all the instruments were removed carefully under vision. Fascia of ports ≥10 mm was closed with polyglactin (0) and skin was closed with monofilament polyamide (2-0). PSI was defined according to the National Nosocomial Infections Surveillance (NNIS) system.

Wounds were assessed clinically after surgery and in case of infection, were treated with regular cleaning and dressing, with empirical oral antibiotics. PSI was studied in relation to frequency, type of surgery, port position, size and number of ports.

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Similarly, ports site bleeding, were studied in relation to frequency, site, type of ports, size and number of ports. Regarding cases of ports site pain, pain prescribed through pain score paragraph and classified from (1-10) and in case of persistent pain lasting more than 1 week, not relieve by simple analgesia and pain score > 6 considered as ports site complication. Further ports site complications were studied in relation to age, sex, body mass index (BMI), total number of ports used, technique of port closure, and procedure performed. BMI was calculated as body weight divided by the square of the body height, and patients classified according to the results of BMI to an underweight (under 18.5 kg/m2), normal weight (18.5 to 25 kg/m2), overweight (25 to 30 kg/m2), obese (30 to 35 kg/m2) and morbidly obese (over 35 kg/m2).

Then follow up continue of 90 days' post operatively either at the outpatients' clinic in the hospitals or private clinic or by phone communication with the patients.

Statistical analysis was carried out and data was entered on excel sheet, and expressed as figures and tables with frequencies or number (N), and percentage (%).

A p value of less than (0.05) was considered significant.

RESULTS

In the current study, a series of 220 patients including 41(18.7%) males and 179(81.3%) females were operated. A total of 38 (17.27%) patients had port site complications (Figure 3). Complications were seen in 29 females and 9 males (p >0.05). Patients were in the age range of 9 to 80 years. Port site complications were common in the 40-60 age groups 19 (8.6%) and significantly related to age (p <0.05).

Port site complications were common in the obesity group with no significance in relation to the frequency of port site complications (p >0.05) (Table 1). Laparoscopic cholecystectomy was the most commonly performed procedure (71.8% n=158) with highest port site complications (15% n=33) in our study population (Figure 3).

Most common ports involved were epigastric port sites (12.7%, n =28) (Figure 2).

Port site complications were non significantly increased with increased number of ports (p = 0.109); however, complications most commonly occurred when use 5 ports (Table 2). Of 47 complications, 28(12.7%) were due to port site pain (Figure 1).12(5.4%) patients developed port site infection. All cases of PSI were superficial wound infections, seven (6.3%)of them without use prophylactic antibiotic and 5 (4.5%) with prophylactic antibiotic with no significance in relation (p>0.05) (Table 3).

In this series Five (2.2%) patients developed port site heamatoma and two (0.9%) patients developed port site bleeding; all were minor vessel injury during the placement of secondary trocars. The procedures involved was cholecystectomy (n

=7). Bleeding was managed with electrocoagulation or lateral compression of ports or suturing. The ports involved were epigastric (n = 2) bleeding, umbilical (n =5) heamatoma.

Most frequent complications associated with open method of entrance of first port (36.3%), closed method associated with only (11.1%) while veress needle had no complications with significance in relation to the frequency of port site complications (p <0.05) (Table 4). Complications occurs more frequently 23 (18.4%) when assistant introduce first port with no significance (p>0.05) (Table 5). Port site complications more frequent when anticoagulant used 16 (34%), when local anesthesia did not used 29 (21.9%) with significance in both relations (p<0.05) and with drain 26 (20%) without significance (p>0.05) (Table 6).

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Figure (1) Relation between types and frequency of complications.

Figure (2) Relation between sites and types of complications.

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Figure (3) Relation between procedures and ports site complications (n = 38)

Table (1) Correlation between gender, age, BMI and complications Complications

P value

No Yes Total

Gender Female 150 29 (16.2%) 179

0.380

Male 32 9 (21.9%) 41

Age\

Years

<20 19 1 (5%) 20

0.006

(20-29) 32 6 (15.7%) 38

(30-39) 51 4 (7.27%) 55

(40-49) 35 12 (25.5%) 47

(50-60) 30 7 (18.9%) 37

>60 15 8 (34.7%) 23

BMI Category

Normal weight 49 5 (9.25%) 54

0.150

Overweight 46 12 (20.6%) 58

Obesity 73 17 (18.8%) 90

Morbid obesity 14 4 (22.2%) 18

Total 182 38 220

Table (2) Correlation of ports size, number, port extension and complications (n

=220) Complications

P value

No Yes Total

Port site extension No 110 23 133 0.992

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Yes 72 15 87

Port size 5 mm

1 5 1 6

0.753

2 171 36 207

3 4 1 5

4 2 0 2

Port size 10 mm

0 1 0 1

0.028

1 40 2 42

2 139 36 175

3 2 0 2

Size 12 0 177 38 215

0.301

1 5 0 5

Total ports/patient

3 36 3(7.6%) 39

0.109

4 143 34(19.2%) 177

5 2 1(33.3%) 3

6 1 0(0.0) 1

Total 182 38 220

Table (3) Relation between use of prophylactic antibiotic and complications.

Infections

P value

No Yes Total

Prophylactic antibiotic use

No 103 7 (6.3%) 110

0.553

Yes 105 5 (4.5%) 110

Total 208 12 220

Table (4) Relation between method of entrance of first port and complications.

Complications

P value

No Yes Total

Method of entrance

Veress needle 4 0 (0.0%) 4

< 0.001

Open method 35 20 (36.3%) 55

Blind method

(direct) 143 18 (11.1%) 161

Total 182 38 220

Table (5) Relation between introducer of first port and complications.

Complications

P value

No Yes Total

Introducer Surgeon 80 15 (15.7%) 95

0.612

Assistant 102 23 (18.4%) 125

Total 182 38 220

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Table (6) Distribution of complications with the use of anticoagulant, local anaesthesia and drains.

Complications

P value

No Yes Total

Anticoagulant No 151 22 (12.7%) 173

< 0.001

Yes 31 16 (34%) 47

Local anaesthesia No 103 29 (21.9%) 132

0.024

Yes 79 9 (10.2%) 88

Drain No 78 12 (13.3%) 90

0.198

Yes 104 26 (20%) 130

Total 182 38 220

DISCUSSION

Laparoscopic surgeries have become the gold standard for many surgical diseases and has been subjected to a rapid development throughout the last years, and many surgical operations formerly carried out through large abdominal incisions are now performed laparoscopically through small incisions (21). Reduction of the complications of access by avoidance of large incisions has been the driving force for such development. However, the insertion of needles and trocars necessary for the insufflation to produce pneumoperitoneum and the performance of the procedure are not without risk and still they can produce undesirable effects and morbidity (12). Traditional diagnostic laparoscopy has been associated with a well-studied morbidity.

The modifications of techniques that imposed by surgical laparoscopy are obvious (e.g., size and number of trocars, specimen retrieval and location of insertion sites), and therefore morbidity may be substantially modified (22).

Complications such as retroperitoneal vascular injury, intestinal perforation, wound herniation wound infection, abdominal wall hematoma, and trocar site metastasis have been reported, and these complications although are rare and associated with lower morbidity and mortality in comparison to the open surgery, but often most of them are preventable and can be avoided by modify their sources and technics and can be further reduced by proper selection of patients, and strictly following basic principles of laparoscopic surgery (23). So that it is very important to know how frequent they occurs and their associated factors and how we can deal with Port site complications can be classified into access related and postoperative complications and have been reported in both the genders and all age groups with different frequency.

In this study of 220 patients 38 (17.2%) had developed ports site complications which is go with Honeypalsinh et al observations (16.7%) (24), while it is high in comparison to Mudgal et al (8.6%) (25), Karthik et al (3%) (18) and other studies, in fact that we considered a ports site pain as a complication, in a total of 28 patients (12.7%), while others did not mention postoperative ports site pain as a ports site complications.

In this series laparoscopic cholecystectomy 158(71.8%) was the commonest procedure performed and was more frequently associated with port site complications 33(15%). Mudgal MM et al (25) and Fuller et al (26) reported similar observations.

Regarding the number and size of ports, port site complications were increased with increased number of ports and reported more frequently with 5 ports/patients and significantly increase with increase number of port size 10mm, when 3 ports 10mm/patients used, with (p<0.05) as shown in (Table 2), Similarly, Neudecker et al

(27), had reported that port site complications were increased with more number of

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ports with significant relation by p value, so this may pay our attention to decrease number of ports/patients and avoid unnecessary large ports to decrease incidence of ports site complications as much as possible.

Most patients collected in our study were in age group (30-40). Similarly, Karthik et al (18) had same observation.

In this series we report that complications increase significantly with age (p<0.05) and more frequent in age >60 (34.7%) as shown in (Table1). This fact may lead to inferred that this group of old patients who already had low immunity and who were suffering from other co-morbid conditions were at increased risk of complications from laparoscopic surgeries.

In our study 12 patients (5.4%) from our study had port site infection (Figure 3).

Similarly, a study by Ravindranath GG et al (28) report the incidence of port site infection in (6.4%), also by Sujith Kumar et al (29) (5.7%) and Al-naser KH et al (30) (4.5%) and Mukesh Kumar et al (31) (3.7%) PSI were reported. Gupte et al (32) reported a lower incidence of PSI (2%), this may be due to the fact that in his study all patients received antibiotics preoperatively while in our study only 50% of patients received antibiotic preoperatively, with decrease in PSI in relation to preoperative used of antibiotic, but in statistically non-significance (p>0.05). and colorectal operations that included in our study and excluded by Gupte et al may increase the incidence of PSI in addition to sterilization technique of ports that used in different study. With these result from our study and others we concluded that laparoscopic surgery is procedures that better preserve immune function of the body and a reduce the inflammatory response thereby, we can reduce significantly the rate of postoperative infections.

The most affected port by complications was epigastric port in our study as shown in (Figure 2) this in comparison conducted with Gupte et al (32) and Jan et al (33) observations. While Ravindranath GG et al (28) mentioned umbilical port as the most frequent affected port in his study, and this perhaps because of that in our study the most common operation done was cholecystectomy in more than 71% of collected patients and the excised samples in these operations (gallbladder) extracted from epigastric port in addition to that the epigastric port was the most frequent port subjected to extension which in turn may increase PSI.

Port site bleeding and heamatoma in our study were observed in 7 patients (3%), all were minor vessel injury during the placement of secondary trocars and managed with electrocoagulation or lateral compression of ports or suturing. This similarly mentioned by Mudgal et al (25) with (2%), while in Deepak sharma et al (34) study reported lower incidence of bleeding (0.7%) only and this may be because he used a veress needle and open method only in creating pneumoperitoneum while in our study we use direct trocar insertion (closed) method in majority of cases and this is almost done blindly which may lead to increase the chance for bleeding and heamatoma at ports site from minor abdominal wall vessels (Table 4).

Ports site pain reported as a most common complication in our study in 28 (12.7%) (Figure 3) and all other studies did not mention postoperative ports site pain as a part of ports site complications as we mentioned and we found that this common postoperative complaining is important to reported in our study and to try to search about its aggravated factors and management. Patients Pain from placement of trocars is expected, but can be minimized by using the least number of ports required to perform the procedure safely and avoid unnecessary port extension. This pain decrease with use of local anaesthesia in statistically significant relation (p<0.05), and pain increase with use of drains but statistically no significance as (p>0.05), this may reflect the importance of effect of local anaesthesia in reducing post-operative pain

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and inversely effect of drains as a local factor to increase incidence of pain. In all patient's pain subside with simple analgesia and follow up for 1 week and showed that pain was completely subsided.

In this study, most common ports site complications occur in abnormal weight group in relation to BMI (38.8%) as shown in (Table 1), this may reflect that obesity is one of the risk factors for increased morbidity related to port site because we will use longer trocars, increase thickness of abdominal wall, larger incision to reach fascia with adequate exposure, and limitation of the instrument mobility due to increased abdominal wall thickness. Hence, care must be taken during placement of trocars to align their axes as needed for the procedure.

Most common complication related to obesity is hernia, in this study, no case of ports site hernia was detected in the short period of follow up for three months and this does not reflect the real incidence of hernia because we need to follow up patients at least 1-2 years to exclude or report hernia in ports site, Morita Y et al (35) reported port site hernia in (1%) of sample and Tomioka et al (36) reported a higher percentage (3.5%) in his study, so it is rare laparoscopic complication and need long period of follow up to be detected or excluded (3-24 months) as mentioned in Tomioka et al (36) study that follow for 2 years and Comajuncosas et al (37) that follow his patients for 3 years.

Closure of facial edges is recommended for ports ≥10 mm; the fascia is closed by suturing it's edges to decrease the risk of ports site hernia. Reapproximation of the fascia can be accomplished in a variety of ways. Ideally, with the aid of retractors, the fascia is directly examined and its edges is visualised. The fascial edges are grasped and sutured with continuous or interrupted suture. There are a many of instruments for fascial closure at the port site (e.g. Carter-Thomson needle-point suture passer).

There were no major complications in our study regarding visceral and major vascular injuries also no subcutaneous emphysema was reported as shown in (Figure 3), similarly Gopal Sharma et al (12), Pankaj Dugg et al (38) and H. Yadav et al (39) did not report any case of visceral or vascular injury nor emphysema, while Deepak Sharma et al (34) reported only (0.5%) subcutaneous emphysema in his study and Ghata S. et al (40) recognize (1%) as both visceral and vascular injury during port insertion in his study and (2%) for emphysema and these may be related to the small sample we collected during our study during short period (3 months) and the fact that these complications are very rare in laparoscopic surgeries and may need larger sample of patients to be reported.

Regarding ports introducer, we report no significant changes or differences in the rate of complications between the surgeons (15.7%) and assistants (18.4%) when involved in ports insertion especially the first port to create pneumoperitoneum and this in fact may be due to that the oriented and a well training assistants involved in our study lead to decrease and avoid preventable causes and sources of complications that may occurs during laparoscopic procedures.

CONCLUSIONS

1) The ports site complications are important part of laparoscopic morbidity.

2) Most of the complications are avoidable when using perfect surgical technics and skills.

3) Ports site pain is the most frequent and important post-operative complications.

4) Ports site complications increase significantly with increase age, BMI, ports number and with open method for ports entrance while decrease with using local anesthesia and with verres needle technique for entrance.

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RECOMMENDATIONS

1) Using Verres needle technique for ports site entrance and local anesthesia to decrease ports site complications

2) New study with same objectives but with larger sample and for longer period of follow up.

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