Hem-o-lok clip versus hand-made loop in base closure during laparoscopic appendectomy in children

Acute appendicitis is one of the most common surgical emergencies in children [1]. Laparoscopic appendectomy (LA) has been progressively used as the management of choice in children since its inception in 1992 [2], and currently about 75% of the patients with appendicitis are laparoscopically managed [3].

Advantages of LA over the conventional open appendectomy have been obviously declared in the last years. These advantages include lesser postoperative pain, shorter hospital stay, faster recovery and return to normal daily activities, and moreover there is a reduced liability to the onset of surgical site infections [4].

Although the operative technique of LA is established and practiced, some variations are still present regarding the patterns of appendicular base closure [5]. There are several methods available depending on the surgeon’s experience or preference, such as endoloop, endoscopic stapler, hem-o-lok clip, titanium clip, extracorporeal and intracorporeal knot [6], and others reported good results relying on hand-made loop because of its better economic value when compared to aforementioned methods [7, 8, 9].

The aim of this study was to evaluate the efficacy and safety of hem-o-lok clip in securing the appendicular base during LA in children to compare its results and outcomes with hand-made loop.

This prospective study included all patients younger than 18 years of age presented to our hospital and affiliated centers with acute appendicitis, and underwent LA in the period from 1st of January 2017 to 30th of March 2018. The patients were randomly divided into two groups according to the method used for appendicular base closure; in the first group, hem-o-lok clip (Ankalaps polymer ligating clip) was used, while in the second, hand-made loop (prepared by operating surgeon using Vicryl suture 2-0, Ethicon) was adopted. This randomization was achieved by the closed envelope method. The study has been approved by the Internal Review Board (IRB) and all the patients enrolled in this study have been informed. A written consent was signed by the parents for the surgical technique and the method used for stump closure. Cases with perforation at the appendicular base were excluded.

Operative time was estimated as the time from introducing the laparoscopic camera till extracting the appendix, while the time of application for each method was estimated from the introduction of hem-o-lok clip or hand-made loop into the abdomen till transection of the appendix. Data were collected and grouped according to the method used for appendicular base closure including patients’ demographics, operative time, time of application, intra- and postoperative complications, length of hospital stay and cost of supplies. Data statistics was done using SPSS (statistical package for social science version 19.0).The results between both groups were compared by t test and Chi-square test. The quantitative variables were expressed as mean ± standard deviation (SD). Statistical significance was accepted when the p values were less than 0.05.

Surgical technique

The procedure was performed using the classical three-port technique (one 10 mm port at the umbilicus for telescope and other two 5 mm working ports, first at suprapubic region and the second either at left iliac fossa or right hypochondrium). After pneumoperitoneum and standard exploration, the appendix was identified followed by sealing of the mesoappendix by electrocautery.

In the first group, the telescope was disconnected from umbilical port and another 5 mm camera was applied through the second 5 mm port, then double hem-o-lok clips (size L) were placed by its special applier for securing the appendicular stump through umbilical port (Fig. 1). In the second group, the hand-made loops were introduced via the second 5 mm port to close the base of appendix by double ligations (Fig. 2).

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The appendix was transected few millimeters distal to double hem-o-lok clips or double hand-made loop ligatures (Figs. 3 and 4). Eventually, the appendix was removed in both groups through umbilical port. Suction and irrigation were performed if intraperitoneal pus was present and then skin incisions were closed. Patients were followed up after 1 week postoperatively at outpatients’ clinic, and another visit was scheduled after 3 weeks for further evaluation.

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During the study period, 44 patients with acute appendicitis were laparoscopically managed and enrolled for analysis. The hem-o-lok clip group (Group I) consisted of 21 patients (13 males, 8 females: mean age was 10.12 years; range 5.5–17 years), while the hand-made loop group (Group II) consisted of 23 patients (14 males, 9 females: mean age was 8.96 years; range 5–14 years).

Mean operative time was 29.95 ± 8.33 min in the hem-o-lok clip group (range 18–47), whereas it was 38.78 ± 4.91 min in the hand-made loop group (range 31–52) and reached statistical significance (p = 0.001). A significant difference was also observed regarding time of application between both methods, median time in hem-o-lok clip group was 3.1 min (range 1.8–5 min), while it was 5.1 min (range 4–11.2 min) in hand-made loop group (p = 0.002). No intraoperative complications have been encountered in both groups and none of the patients needed conversion to conventional open appendectomy.

The mean postoperative hospital stay was 1.74 days in the hem-o-lok clip group (range 1–3) and it was 1.38 days in the hand-made loop group (range 1–3) not reaching statistical significance (p = 0.068). Among the 44 patients who were included in this study, 3 patients had postoperative complications. These cases had wound infection at the umbilical port site (1 in hem-o-lok clip group, 2 in the hand-made loop group) and all of them were managed successfully by daily dressings and antibiotics. There were no significant differences between the two groups regarding the postoperative complications [Table 1].

In terms of costs, a cartridge of hem-o-lok clips (containing 6 clips) to be used per each case costs approximately 14 USD in our country, whereas a single package of Vicryl ligature 2-0 for forming hand-made loops costs only 4 USD.

Although LA in children has been considered as an effective and feasible procedure for the treatment of acute appendicitis, there are technical aspects regarding base closure that still need further analysis [4]. The most suitable method for stump closure is still under debate, and actually there is no consensus on one method [10, 11, 12].

Currently, endoloops and endostaplers are the commonest modalities used for closure of the appendiceal stump. Both methods achieved good results in several studies [13, 14], meanwhile endoloops have been recommended for its economic value, whereas others reported that endostaplers should be adopted in cases with perforation at the base [15].

Cost of supplies is a major point for laparoscopic procedures in developing countries. During the last few years, we depended on hand-made loop for base closure during LA in children in our hospital. Hand-made loop is a modification of the Roeder knot which has been described in the literature and proved to be safe [16]. This loop is easy to be constructed using a single package of Vicryl suture. Hand-made loop costs only 4 USD in contradictory with endoloop which costs about 50USD in our locality, thus this led us to rely on hand-made loop.

Hem-o-lok clip is a non-absorbable polymer clip and the safety of its use for ureters and vessels clipping has been obviously declared in previous studies [17, 18]. The comparison between hem-o-lok clip and endoloop for appendicular base closure has been documented in several studies in adult and pediatric patients [19, 20, 21, 22], while the comparison between polymer clip and hand-made loop has still not been documented.

This prospective study has compared the application of hem-o-lok clip as a new technique for stump closure in our hospital to the hand-made loop. It is to be noticed that there were no significant differences between both groups regarding operative outcome. Postoperative complications encountered were not related to the technique used for securing the appendicular base and none of the patients required re-admission or additional procedures, so this confirmed the safety of both methods used in our study. This study also did not show a significant value regarding the length of postoperative hospital stay among the studied patients.

The current study reveals significant shorter operative time in favor of hem-o-lok clip group, and this could be due to the simplicity of its application even by a first-time user. Similar results were observed in other studies which depended on polymer clip in comparison to the use of endoloop [19, 21, 22], whereas Colak et al. has reported that mean operative time was shorter in hem-o-lok clip group than endoloop group, however, the difference was not significant [20].

As regards the costs in our country, the hand-made loop is cheaper than polymer clips, 4 and 14 USD for each procedure, respectively. In the current study, hand-made loop achieved perfect results as a safe and low-cost method and it could also dispense with the use of endoloop. Other studies found similar results that hand-made loop is a safe and cost-efficient method and they also declared that usage of other costly modalities such as endoloops or endostaplers seems unnecessary [7, 8, 9].

Hem-o-lok clip is safe, its application is very simple and does not require advanced laparoscopic skills, as the technique is similar to cystic duct clipping during laparoscopic cholecystectomy and in addition the locking mechanism provides tactile feedback and secure closure. Although it is slightly more expensive than the hand-made loop, it offers lesser operative time which is the principal advantage over hand-made loop. Polymer clips still have a limitation to be used in patients with appendix base more than 10 mm in diameter [23] and few cases of failure were reported in previous studies [19, 23, 24]. The authors of this study believe that such a problem is negligible to be encountered in children.

On the contrast of polymer clip, hand-made loop needs advanced training and more skills in minimally invasive surgery and it also takes longer time for application on the appendiceal base. Hand-made loop has several advantages as an efficient, safe and simple technique as it was constructed with only a single Vicryl suture. It also has no limitation or size cutoff regarding the appendicular base diameter. Hand-made loop offers low cost over hem-o-lok clip and it is clearly concluded that hand-made loop is the cheapest method for stump closure achieving a high level of cost effectiveness which is a fundamental concern in developing countries where equipment like endostaplers or endoloops are not always available, so this might eliminate the resistance against LA.

During LA in children, appendicular base closure using either hem-o-lok clip or hand-made loop is effective and safe without significant differences in surgical outcomes or complications rate. Hem-o-lok clip offers lesser operative time as a main advantage when compared to hand-made loop which is superior because of its economic value. Finally, the current study clearly emphasizes that the choice between both methods should be made according to the cost and surgeon’s preference.