Comparison of Complications between Direct Trocar Insertion Versus Veress Needle for Creation of Pneumoperitoneum in Patients Undergoing laparoscopic Cholecystectomy: A Randomized Control Trial

1 Department of Surgery, Islam Medical College, Sialkot, Pakistan. Department of Surgery, Khawaja Muhammad Safdar Medical College, Pakistan. 3 West Surgical Unit, Mayo hospital/King Edward Medical University, Lahore, Pakistan. 4 Department of Surgery, CMH Medical College, Lahore, Pakistan. Department of HPB Surgery, Shaikh Zayed Hospital, Lahore, Pakistan. 6 Department of Pulmonary and Critical Care Medicine, Services Institute of Medical Sciences, Lahore, Pakistan. 7 Department of Hepatology and Gastroenterology, Bahria International Hospital, Lahore, Pakistan. 8 Department of Internal and Critical Care Medicine, Bahria International Hospital Lahore, Pakistan. Department of Medicine, Expert Doctor Private Limited, Lahore, Pakistan.


INTRODUCTION
Evolution of laparoscopic surgery started in 1910, when a Swedish surgeon Jacbeus performed a first laparoscopic surgery. In past few decades this technique has gained primary importance in various surgical procedures, laparoscopic cholecystectomy is one of them. Now for uncomplicated symptomatic cholelithiasis, it has considered the gold standard around the globe [1]. Laparoscopic surgery has many beneficial effects as compared to the conventional surgical methods such fewer number of attempts to create pneumoperitoneum, cost effectiveness and cosmetic benefits. Although it is superior then the open procedures but still has complications during the creation of pneumoperitoneum. More than 50% complication occur during the insertion of trocar [2]. Different techniques such as Veress, direct or with disposable shield trocars, radially expanded trocars and visual systems were used to overcome the complications [3]. But literature showed none of the technique clearly indicate the beneficial effect over the others. So mostly it is decided by the surgeon at the time of operate which technique should be adopted. The current RCT was an attempt to assess the efficacy and safety level of direct trocar insertion versus veress needle insertion techniques to create a successful pneumoperitoneum with minimum complications, so that we can develop some local guidelines for junior surgeons.

MATERIALS AND METHODS
In this current Randomized control trials was conducted from September 27, 2017, to September 26, 2020. Total of six hundred and eight (n=608) patients of uncomplicated symptomatic cholelithiasis with planed laparoscopic cholecystectomy were included after taken the written consent from Khawaja Safdar Medical College Surgical Department, Allama Iqbal Memorial Hospital and Govt. Sardar Begum Teaching Hospital Sialkot. Both male and female with age ranging 30-75 years old were divided into two equal groups. Group A contained 304 patients in which the pneumoperitoneum was created through direct trocar insertion (DTI) and Group B had same number of age and sex matched patients undergone veress needle insertion (VNI). Patients having history of advanced gastrointestinal or gynecological procedures, chronic liver disease detected on ultrasound abdomen and coexisting deranged Liver function tests, ischemic heart disease (evident on ECG as Q waves), para-umbilical hernia, and previous laparotomy were excluded from the study. All patients underwent a full history, which was followed by a thorough routine examination and baseline investigations. During laparoscopic operations to create pneumoperitoneum with veress needle or direct trocar insertion, patients were randomly split using a lottery technique. Each chosen instance was carried out by an experienced General Surgeon. During direct trocar insertion technique, the patient is positioned in the same manner as in veress needle insertion, that is supine with a 20-to 30-degree Trendelenburg tilt. The collected data was analyzed by using the software SPSS version 22. Mean and standard deviation were calculated for numerical variables like age and BMI. Frequencies and percentages were calculated for categorical variables like gender. Chi square test was applied in which p value ≤ 0.05 was considered as significant value to compare the outcome in both groups. Post stratification Chi square test was applied with p value ≤0.05 considered statistically significant.

RESULTS
In this study there were 211 (34.70%) male and 397 (65.30%) were the female patients. Mean age with standard deviation of patients was 47.99 ± 11.01 years (minimum age was 30 years and maximum age was 75 years). Mean body mass index (BMI) of study patients was 26.18 ± 3.88 kg/m 2 (Minimum BMI was 17.26 kg/m 2 and maximum was 37.18 kg/m 2 ).
Complication rate was noted significantly higher in the group B (VNI) as compared to group A (DTI), (21.67% and 2.88% respectively, P <0.01). In our study the minimal subcutaneous and omental emphysema taken as complication. Among all complications, gastric perforation and iliac artery laceration were considered major complication and were managed by open surgical procedure. We found statistically significant different in complication rate in two groups, shown in Table 2.
The time to set up pneumoperitoneum was less in the direct trocar's technique as compared to veress needle technique (3.4+ 1.4 minutes and 4.8+ 0.7 minutes respectively, p = < 0.001), but no difference was found in total time take by the laparoscopic cholecystectomy.

DISCUSSION
The DTI method progressively becoming the method of choice by the surgeons and gynecologists for creation of pneumoperitoneum. The increased use is mostly because of this treatment has fewer problems, both major and minor, and it is expected to be the technique of choice soon. The veress method for producing pneumoperitoneum is still a regularly used technique by the surgeons [1]. The complications associated with the use of the veress needle, on the other hand, cannot be denied, and prompting  [14][15][16]. Debates on the safety of laparoscopic surgery generally focus primarily on procedure-specific complications, such as biliary injury in laparoscopic cholecystectomy, and secondarily non-biliary injury, i.e., vascular, or enteric injuries caused by the main procedure. Access-related major vessel or bowel injuries caused by entry were noted in our study ranging 0 to 0.3% as infrequent as report in another study 0.1 -0.4% [Arif, 2021 #6][17-19]. It has been reported that 83% of vascular injuries, 75% of bowel injuries, and 50% of local hemorrhage injuries were caused during primary trocar insertion [20-23]. It is anecdotal, but very possibly true, that these complications are under reported, especially as the minor complications associated with entry have minimal impact on the overall outcome. Increasingly more general surgeons and gynecologists are using the DTI technique in laparoscopic surgery now a days. The rise in its use is principally because there are fewer complications, each major and minor, with this procedure, and it is likely to become the most suited alternative soon. One of the benefits of DTI is early recognition of any major complication before insufflation of abdomen. Other advantages of DTI are avoidance of complications associated with veress needle insertion like frequent preperitoneal or intestinal injuries, failed pneumoperitoneum and CO 2 embolism [12, 24,25]. In the study by Inan A et al, concluded that direct trocar entrance also reduces the operation time, but in our study the mean time for surgery was not differ in two groups. A study conducted at Akhtar Saeed Medical College Surgery department enrolled 30 patient each in DTI and VNI group were allocated, and complication rates of both groups were studied. In their study there was less time taken in DTI group to create pneumoperitoneum similar to the results of our study [26].

CONCLUSION
From the results of our study, it can be concluded that the direct trocar insertion is a safe alternative to veress needle insertion in laparoscopic cholecystectomy because it is associated with less number of complications as compared to the Veress needle and also required less time to create safe pneumoperitoneum.

DISCLAIMER
The products used for this research are commonly and predominantly use products in our area of research and country. There is absolutely no conflict of interest between the authors and producers of the products because we do not intend to use these products as an avenue for any litigation but for the advancement of knowledge. Also, the research was not funded by the producing company rather it was funded by personal efforts of the authors.

ETHICAL APPROVAL
The study was approved by the institutional review board of Khawaja Safdar Medical College.

CONSENT
As per international standard or university standard, patient's written consent has been collected and preserved by the author(s).