Tie versus clipping typed of cystic duct and artery ligation in laparoscopic cholecystectomy

Background: In laparoscopic cholecystectomy (LC) cystic duct and cystic artery (CDCA) are usually secured by using Titanium clips. Because of some complications may occur in application of clips; like dislodgement and migration of the clips, so other different techniques have been used, like intra or extracorporeal ligation, using of absorbable clips, harmonic scalpel or LigaSure. Intracorporeal ligation takes more time than applying a clip, and it needs well training. In the other hand clipping have a challenge in cases with wide cystic duct. The objective of the study is to compare the efficacy and safety of suture ligation versus clipping, in securing CDCA in LC, and also time difference of operations in both methods. Methods: A Prospective study included 94 females, and 32 males underwent LC; in 51 patients CDCA were secured by intracorporeal ligation separately, and in 75 patients CDCA were secured by Titanium clips. Postoperatively the patients followed up in the outpatient clinic at the end of the first and second postoperative weeks for any complication. Results: There were no significant differences in the operation times between the two groups (pvalue: 0.08), and also no significant difference found between the operation times and the different presentations, history of upper abdominal surgery, present of umbilical hernias, and different BMI. There was no peroperative bile duct injury and no postoperative bile leak, intraperitoneal collection, or jaundice, in both groups. Conclusion: Suture ligation for CDCA is safe and effective. Learning intracorporeal knotting is important and plays an important role even in addition to the use of the clipping, and should be the recommended training in basic laparoscopic surgery.


INTRODUCTION
Laparoscopic cholecystectomy (LC) is a common surgical procedure and has improved surgical outcomes if compared with open cholecystectomy (OC), it has less postoperative pain, shorter hospital stay, quicker return to the normal activities and a more cosmetic outcome, but it needs higher infrastructure and expensive equipment. LC also associated with higher morbidity, such as bile duct injury (BDI), bile leakage, injury to the surrounding structures, uncontrolled hemorrhage, spillage of gall stone (GS), biliary strictures, and clip slippage. 1 Postoperative bile leak is a serious complication, occurs in about 0.3% of cases. 2 In LC, cystic duct and cystic artery (CD-CA) are usually secured by using Titanium clips. There are other different techniques for securing CD-CA, like intracorporeal ligation by separate and multiple ligatures for CD-CA by absorbable suture material, or extracorporeal ligation, using absorbable clips, harmonic scalpel or LigaSure. 3,4, 5 The problem of using these advanced tools they are expensive for developing countries, as in a study done in India showed that suture ligation of CD appeared to be more cost effective. 6 On the other hand, the application of clips shown to have some drawbacks such as dislodgement and bile leak, 7,8,9 there are reported cases after long term follow up shown clip migration which resulted in biliary stone formation, 10,11,12 or bile duct stenosis. 13 In other studies, they found that clips ulcerated through the duodenum. 14 Although intra-corporeal ligation takes more time than applying a clip, and it needs well training, and in some series they found that ligation of CD-CA separately does not increase operative time if the surgeon has experience for intra-corporeal knotting. 15 And some others thought that it is feasible, cost-effective and safe alternative method to secure CD-CA in LC. 3 Although clipping and the use of Harmonic scalpel are an efficient and practical method for securing CD-CA in LC, they have a challenge in cases with wide CD (more than 5 mm). 7 The Aim of this study is to compare the two different methods; Tie versus clipping, for securing CD-CA in LC, in terms of efficacy and safety, and also the difference in the times of operations in both methods.

METHODS
A Prospective study was done between 23 rd of February, and 22 nd of May 2019, in Sulaimani Teaching Hospital and Baxshin private hospital in Sulaimani city. The study included patients with symptomatic GS who underwent LC; performed by two teams were using different methods. Consents were obtained from all participants included in the study for both methods. Demographic data (age, gender, and residency), body mass index (BMI), previous cholecystitis, pancreatitis, endoscopic retrograde cholangiopancreatography (ERCP) and previous abdominal surgery, all recorded before the operation. Postoperatively the patients followed up in the outpatient clinic at the end of the first and second postoperative weeks for any complication. Both groups had mixed cases of GS; acute and chronic Cholecystitis. The standard technique of LC was carried out with four ports and using a 30-degree laparoscope. Special attention was taken, like adequate insufflation of CO 2 , good lightning, using of cauterization after holding the tissue under complete visualization. The intraoperative findings and complications recorded. The times of the operations estimated from the first skin incision until the closing of the skin wounds. Any case of conversion to OC was excluded.
Group A: include 51 patients had LC, done in Sulaimani Teaching hospital, ligations of CD-CA were done by tying them using 2/0 vicryle suture material by intra-corporeal knotting separately.
Group B: include 75 patients had LC, done in Baxshin private hospitals, clipping of CD-CA were done by using Titanium clips. The data after collection were entered into an excel sheet then after data clearness transferred to Statistical Package for Social Sciences (SPSS) program version 21 for analysis. P-value equal to or less than 0.05 was regarded as statistically significant.
From those 126 patients, in 51 patients CD-CA were ligated by ties (2/0 Vicryle), while in 75 patients CD-CA were secured by clips. There were no significant differences in the times of the operations ( Table 2).
There was no significant difference between the times of the operations and the presentations, and also there was no significant difference between the times of the operations in both groups (Table 3).
All patients who had a history of ERCP were operated in the group-A, and there was no significant difference in the times of the operations with comparison with those who had no history of ERCP (Table 4).
There was no significant difference between the times of the operations and history of upper abdominal surgery and between the times of the operations in both groups (Table 5).
There were no significant differences between the times of the operations and presence of umbilical hernias, and also between the times of the operations in both groups (Table 6).
There was no significant difference between the times of the operations regarding BMI, and also between the times of the operations in both groups (Table 7).
During the operations, there were perforations of the GB in 22 cases (17.5%), but there was no significant difference between the times of the operations in both groups (Table 8).
We have two conversions that were excluded from the study. We have no per-operative BDI and no postoperative complications in terms of bile leak, intra-peritoneal collection, or jaundice, in both groups.

DISCUSSION
Many methods have been studied to be used as techniques for securing CD-CA rather than applying metal clips, for the expectation of long-term morbidity. In a study done in Japan, they found in their review of the literature that almost all cases of migrating clips involved metal clips, so they used a polymeric absorbable clip because of the advantageous in degrading within 6 months 16 and some believed that the CD ligation with absorbable thread should be a gold standard in LC 17 because it reduces the risk of postoperative morbidity.
Clipping of the CD-CA is a safe and efficient method, but it has some challenges like cystic duct diameter, 7 so intracorporeal ligation is solution and should be the gold standard in LC 1 especially after good training and also, as we came up with it, it is a safe and easily learned. Although longer time is expected for intracorporeal ligation of CD-CA, no significant differences found in our study in meantime of the operations; 40.157±9.7373 min. for Tie group, and 36.613±11.8537 min. for clip group, with P-value of (0.08), if compared to a study done in India where the meantime was 70.7 min. for ligature group and 46.6 min. for clip group, 1 they attributed that for less experience of surgeons to do intracorporeal ligation, and the meantime was 50 min. in study done by Pradu, 6 where CD ligation alone took 5 min. The meantime taken for the cystic duct ligation was 3.5 min. in a study that included 1000 LC by Golash V 18 and they regarded intracorporal ligation as simple, safe and economical. But in a study done by Seenu V and colleagues they were using polyglactin suture ligature and the time was slightly longer than that using Titanium clips, 19 but it required only extra 2-4 minutes more than clipping in the study done in Bangladesh. 3 In our study, the time of ligation of both CD and CA took 4-6 min. The Main presentation of GS in this study was biliary colic (57%), then AC (38%) and (4.8%) had pancreatitis. Female to male ratio was 3:1, while in a study done in Italy it was: AC (49%) and pancreatitis (4%). 20 GB perforation occurred in 10 patients in group-A and 12 patients in group-B, (17.46%), nearly same in study done by Sharma D and colleagues, 1 but this didn't make significant difference in the time of the operations in our study (p-value 0.08). Seven patients (5.6%) in our study had a history of ERCP, and preoperative ERCP known to have more chances of having a difficult cholecystectomy 21 and all those patients were operated in Tie group and there was no significant difference in the times of the operations.
In a study done by Osman Riaz, there was 3.3% bile leakage in the clip group while no case in the tie group 22 and a study done in Tehran it was 4%, 23 in our study we have no BDI or bile leak, also no BDI found in the study used absorbable locking clips and showed a lesser incidence in bile leak postoperatively 6 and there was no significant difference in the postoperative outcome in either group in a study done by Seenu V and colleagues. 20 In our locality, the cost of clips, usually 4-5 clips are needed for a case of LC is 5 times more than the cost of an absorbable Vicryl suture used for the tie.

CONCLUSION
Ligation for cystic duct and artery is safe and effective. There were no significant differences found in meantime of the operations. Learning intracorporeal knotting is important in addition to the use of the clipping, especially in places where there are wide cystic duct and unsuitable size of the clip, and should be the recommended training in basic laparoscopic surgery.

ETHICAL CONSIDERATION
The study approved by the Ethical Committee of the College of Medicine of the University of Sulaimani.