Laparoscopic elective cholecystectomy with and without drain: A controlled randomised trial

Abstract

BACKGROUND:

Laparoscopic cholecystectomy is the main method of treatment of symptomatic gallstones. Routine drainage after laparoscopic cholecystectomy is an issue of considerable debate. Therefore, a controlled randomised trial was designed to assess the value of drains in elective laparoscopic cholecystectomy.

MATERIALS AND METHODS:

During a two-year period (From April 2008 to January 2010), 80 patients were simply randomised to have a drain placed (group A), an 8-mm pentose tube drain was retained below the liver bed, whereas 80 patients were randomised not to have a drain (group B) placed in the subhepatic space. End points of this trial were to detect any differences in morbidity, postoperative pain, wound infection and hospital stay between the two groups.

RESULTS:

There was no mortality in either group and no statistically significant difference in postoperative pain, nausea and vomiting, wound infection or abdominal collection between the two groups. However, hospital stay was longer in the drain group than in group without drain and it is appearing that the use of drain delays hospital discharge.

CONCLUSION:

The routine use of a drain in non-complicated laparoscopic cholecystectomy has nothing to offer; in contrast, it is associated with longer hospital stay.

INTRODUCTION

Laparoscopic cholecystectomy provides a safe and effective treatment for patients with gallstones[1] as it reduces post-operative pain with almost inadvisable scar, short hospital stay and earlier return to work.[2]

On the other side, many patients complain of abdominal pain, shoulder tip pain, and nausea/vomiting post-operatively.[3] High pressure pneumoperitoneum using carbon dioxide gas was accused for those complications.[4] Thus, a drainage tube is inserted.[5] The value of surgical drainage in open cholecystectomy is an issue that is not resolved till now.[6] The same in laparoscopic cholecystectomy, where the lack of evidence on usefulness of drain is present. Again surgeons keep being divided among those placing a drain selectively, and those who never place a drain, based on their personal experience, beliefs, or bias.[7]

Therefore, this controlled randomised comparative study was designed to assess the value of drain in uncomplicated laparoscopic cholecystectomy.

MATERIALS AND METHODS

From April 2008 to January 2010, all American Society of Anesthesiologists (ASA) I, II, and III patients admitted to undergo elective laparoscopic cholecystectomy were eligible to enter the study provided that they were > 70 years old, (a) they did not have acute cholecystitis, cholangitis, or pancreatitis; (b) they did not have any contraindication for the laparoscopic approach; and (c) they did not require common bile duct exploration or any other additional procedure. Patients with previous episode(s) of acute cholecystitis, cholangitis, or pancreatitis in their history were not excluded. However, patients who refused to enter the study, converted to open surgery, with chronic liver disease or bleeding tendency, were excluded.

One hundred and sixty patients were simply randomised blindly before surgical procedure into two groups. Group A of 80 patients received a gravity drain in gall bladder bed, and Group B of 80 patients received no drain.). Although entrance into the trial was decided before surgery, the randomisation arm was only notified to the operating team after the completion of cholecystectomy and just before closure of the wounds using sealed envelopes in blocks of 20. Informed consent was obtained from all patients and were told that there is a possibility to be converted to open surgery (if there is a difficulty in laparoscopic procedure, and the trial protocol was approved by the institutional Ethics Committee. The procedure was performed or supervised by the same surgeon's team in Suez Canal University Hospital.

All patients were given a single use of antibiotic prophylaxis (cefuroxime 750 mg) intravenously, and postoperative analgesia (Diclofenac sodium 75 mg) intramuscularly. Postoperative pain assessment was performed using a visual analog scale (VAS) with which each patient noted the severity of pain, using a linear scale between zero (no pain) and 10 (strongest conceivable pain). Abdominal drainage was assessed in terms of quantity and quality of drainage.

Post operative complications such as post operative nausea and vomiting, perihepatic collection, bleeding, wound infection were assessed. All deaths were recorded whether related to laparoscopic procedure or its complications.

Abdominal ultrasonography was done only to patients suspected to have collection (if they have persistent shoulder pain, fever, elevated leucocytic count, persistent vomiting).

Statistical analysis was performed using SPSS 15 for windows. Mean and standard deviation were estimated for each continuous variable. Independent t-test was used for detection of difference between the two means. Differences were considered significant when P >0.05. Witten informed consent was obtained from all patients and the trial protocol was approved by the Local Ethical Committee.

RESULTS

The age range of Groups A and B patients were from 20 to 62 years. Most of them were females (male/female ratio: 24/56 and 20/60) in Groups A and B respectively. The average operative time in the drain group was longer than that of the no drain group (30.8 min versus 25.5 min, respectively). The same for hospital stay, as Table 1 shows that the range in Group A was between 1 and 3 days and 1-2 days in Group B. No mortality was observed whether from the procedure or any of its complications.

Table 1.

Socio-demographic and peri-operative characteristics of both groups

Post-operative pain was assessed using VAS and showed no significant differences between the two groups at 24, 48 h and one week later.

Twenty six patients in Group A and twenty patients in Group B complained of nausea and vomiting. That showed no significant differences between them.

The only post-operative significant complication found was wound infection. Fifteen patients representing 8.75% of Group A had wound infection compared by 4 patients representing 5% of Group B.

Six cases of abdominal collection occurred in Group A in contrast to two cases in Group A; all of those patients responded to conservative management, with no significant difference [Table 2].

Table 2.

Details on morbidity of both groups

DISCUSSION

When Lamgenebuch performed the first cholecystectomy in 1882, he placed a peritoneal drain as a part of the procedure. The routine placement of drains becomes a part of operation for a long period of time. However, controversy has surrounded this practice in elective conventional cholecystectomies, with most surgeons departing from this approach. Surgeons have routinely drained after laparoscopic cholecystectomy because of the fear of collection of bile or blood requiring open procedures.[8] Another reason for draining is to allow CO₂ insufflated during laparoscopy to escape via the drain site, thereby decreasing the shoulder pain.[5,8] A higher proportion of patients with nausea and vomiting has also been noted[9] and these complications are less in gasless laparoscopic cholecystectomy.[10] Studies have shown higher wound infection rate[11] and longer hospital stay in the drain group.[12]

In the present study, the average operative time in the drain group was 30.8 min and 25.5 min in the no drain group but these results show no significant differences.

Hospital stay in drain group ranged from 1 to 3 days and the majority of cases were discharged on the second day, while it ranged from 1 to 2 days and the majority of cases were discharged on the first day in the no-drain group. That showed significant differences. Gurusamy et al.,[13] and Satinsky with his associates[14] have also reported significant differences with longer hospital stay in drained patients.

Hawasli and Brown[15] found that there were minor but not statistically significant differences between drain group and non drain group in terms of postoperative severity and duration of the abdominal pain and shoulder pain. Also, in this study, postoperative pain was assessed using VAS and there was no significant difference. However, Kazuhisa et al.,[16] found that the mean VAS scores were significantly greater in drain group than in non drain group at 24 and 48 h especially in women. On the contrary, Tzovaras et al.,[17] suggested that the routine use of a drain in elective laparoscopic cholecystectomy has nothing to offer and it is associated with increased pain. Gurusamy et al.,[13] and Tarik et al.,[14] reports showed no significant differences in post operative nausea and vomiting between drain and no drain groups. The same was reported in this study also, as 26 patients were complaining in Group A (32.5%) and 20 patients in Group B (25%).

Wound infection occurred in 15 patients of drain group (18.75%) versus 4 patients in no drain group (5%) and that showed significant difference in consistent with the study of Gurusamy et al.[13] All cases responded well to oral antibiotics. However, Hawasli and Brown[15] and Playforth with his team[18] reported that no significant differences were present regarding wound infection in their trials.