Effect of Abdominal Drain on Patient Comfort in Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Study

Introduction

Obesity is a health problem with increasing frequency. Although the superiority of the methods used in morbid obesity surgery to each other is controversial, sleeve gastrectomy is probably the most common procedure in the world today. The main early postoperative patient complaint following laparoscopic sleeve gastrectomy is the pain. There are studies reporting that one of the major causes of this pain is presence of a drain. ¹ There is no consensus on the routine use of drain in sleeve gastrectomy. There is also no prospective randomized study on this subject.

The purpose of the present study was to investigate the effects of the use of drain in laparoscopic sleeve gastrectomy on patient comfort.

Materials and Methods

The approval of the study protocol was obtained from the Corporate Ethics Committee (no: 2016/181). Informed consents were obtained from all patients. The study was recorded in an international database (Clinical Trials: NCT04333979). All procedures were performed under the supervision of two consultant surgeons (C.K. and F.S.). Patients who referred for bariatric surgery between November 2016 and January 2018 and who were scheduled for laparoscopic sleeve gastrectomy were included in the study (Fig. 1). The comorbidities and previous abdominal surgeries of the patients were not used as exclusion criteria. Patients with body mass indices (BMI) 40 kg/m² and above were selected for the study. Cirrhosis patients, those who were younger than 18 years of age, and those who had undergone previous obesity surgeries (revision surgeries) were excluded. A total of 25 patients were randomized into two groups as those who had drains and those who were no-drain. Randomization was carried out simply by heads-or-tails method. Drains were not inserted in one group after laparoscopic sleeve gastrectomy, and 24F silicone drains were inserted in the upper-left quadrant trocar area in the other group. Drains were inserted under the left liver lobe along the sleeve gastrectomy resection line. All the other details were performed as mentioned earlier. ² Patients were given standard deep vein thrombosis prophylaxis for 30 days. If there was <100 mL seroanginous drainage per day in the patient, the drain was removed. Patients were discharged on postoperative 2nd or 3rd days according to their general conditions and living spaces. During discharge, a standard form with instructions was given to the patients.

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FIG. 1.

Patient flowchart.

The demographic characteristics of the patients, their comorbidities, medications, surgery histories, international normalized ratio values, preoperative and postoperative hemoglobin values, additional intervention requirements, duration of surgery, perioperative and postoperative blood loss, blood transfusion requirements, postoperative first 3 days visual analog scale (VAS) scores, and postoperative hospitalization times were examined. The fluid support, treatment protocol, surgical method, number and size of the trocars, drain placement location, and drain type were standardized. The VAS score was evaluated over 10 points. The pain scoring was made as the highest pain score 10 points and the lowest pain score 0. The VAS scores of the patients were examined in the morning without analgesics, and analgesic support was carried out when needed. The VAS evaluation was carried out by surgeons who did not participate in the study. The amount and type of the fluids from the drain were noted daily for 3 days. The statistical analyses of the demographic data and results were made in two different ways as Group Analysis for Therapeutic Purposes and Analysis According to Protocol.

Results

Laparoscopic sleeve gastrectomy was applied to 75 patients during the study period. A total of 25 of them were excluded from the study, because they were included in another randomized study, and the remaining 50 patients were included in the present study. The patients were divided randomly into two groups as those with drains, and those without drains (Fig. 1). A total of 45 patients were female (90%), and 5 (10%) were male. The mean age and BMI were 35.8 ± 10.4 and 45.9 ± 5.7, respectively. A total of 23 patients (46%) had comorbid diseases (9 hypertension, 6 type 2 diabetes, and 5 asthma). A total of 18 (36%) patients had a history of abdominal surgery, and 7 of these were (14%) upper abdominal area surgeries. The mean surgery time was 97.3 ± 54.1 min, and the mean amount of intraoperative blood loss was 54.8 ± 82.6 mL. The drains of the patients were removed mostly on the 2nd (94%) or on the 3rd day. The mean hospitalization period of the patients was 3.4 ± 2.8 days.

Intraoperative complications were detected in three patients. In one of these, the calibration tube was stuck in the stapler line, and the staple line was opened and closed in this area again. One patient underwent re-resection due to inadequate antral resection. In the last patient, there was a bleeding in the trocar area because of inferior epigastric artery injury and was taken under control with the help of Ligasure vessel sealing device. The drains of the patients who were in the drain group were removed on the 2nd day, and the patients were discharged on the 3rd day.

Although two patients were in the no-drain group, they required drains (2/25, 8%). In both patients, the cause of drain was the hemorrhagic oozing in surgical area despite meticulous hemostasis. These venous oozing was not at significant levels, and the surgery was terminated with the drain. The postoperative progressions of these patients were similar to those of the other patients.

A patient had postoperative drop in hemoglobin level. This patient was in the drain group, and no bleeding was detected from the drain. When the patient had melena, gastrointestinal bleeding was suspected and was discharged on the 8th day after two units of erythrocyte replacement. Stapler line leakage was detected in one patient in the drain group. This patient underwent early laparoscopic Roux-en-Y gastric bypass revision surgery, and the patient was discharged without problems on the 8th day. Except this case, there was no organ/space or any other type surgical site infection.

The postoperative 3 days VAS values were 4.1 ± 2.0, 2.4 ± 1.5, and 1.5 ± 1.4, respectively. No significant differences were detected in terms of demographic data, complication rates, surgery times, and blood loss between the two groups. The VAS score comparison between the two groups was based on Per-Protocol and Intention-to-Treat Analyses. According to both analyses, although the VAS values of the first 2 days were lower in numerical terms in the no-drain group, no statistical significance was detected. However, the VAS value was significantly lower on the 3rd day in the drain group (p = 0.03/0.01). Although most patients (62%) were discharged on the 3rd day, there were also patients who were discharged on the 2nd day (28%). Comparative analyzes of the two groups (intention-to-treat/per-protocol) are given in Tables 1 and 2. VAS score measurement was in the morning on day 2 and drain removal was done in the afternoon. Therefore, the VAS score outcomes did not reflect the drain removal pain on day 2. Some patients reported a bad night after drain removal. This may be related with the more pain following drain removal process or the more frequently needed dressing changes at night.

Discussion

Obesity has become a major medical and social problem in western communities in recent years. There has been an increase in the number and variety of surgical procedures used with the increase in its incidence. The two frequent procedures are sleeve gastrectomy and Roux-en-Y gastric bypass. Sleeve gastrectomy has become the most commonly used procedure in recent years with its advantages such as not having intestinal anastomosis, ease of application, good recent weight loss results, not causing hernia defects in the mesentery, and not leaving foreign objects such as bands in the body.^3,4 Major complications are bleeding, abscess, and staple line leakage after sleeve gastrectomy surgery. Major complications were reported as 5% in wider series, and minor complications as 11% (Refs.^5,6). Routine abdominal drains are applied to detect and treat these intra-abdominal complications as early as possible. However, previous retrospective studies suggest that using drains after sleeve gastrectomy does not provide an advantage in terms of abscess, bleeding, leakage, resurgery, and mortality.^7–9 There are no studies examining the effects of using drains in laparoscopic sleeve gastrectomy on postoperative patient comfort.

The most important marker that affects postoperative patient comfort is pain. In the present study, pain scores were found to be lower in no-drain patients. In a prospective randomized study conducted on patients who underwent laparoscopic Roux-en-Y gastric bypass, it was found that postoperative 1st and 3rd day VAS values were lower in the no-drain group. ¹ It was reported that using drain after laparoscopic cholecystectomy has negative effects on postoperative pain.^1,10 In a study conducted on liver transplant patients with live donors, although using drains was considered necessary for postoperative bile and blood drainage, it was concluded that it increased hospital stay times and the risk of intra-abdominal infections. ¹¹ Additional measures should be taken for patients with drains who had neurological/psychiatric problems or blurred conscious. ¹² In a meta-analysis on patients undergoing gastric cancer surgery, it was reported that the duration of drains extended the operation time at a rate of 9 min, and the hospital stay at a rate of 0.69 days. ¹³ Similarly, in a study conducted on patients with perforated appendicitis, it was shown that drain placement increased surgical area infections and hospital stays. ¹⁴ The difference between the surgery times of our patients was ∼15 min, and the difference between hospitalization times was 1.3 days (intention-to-treat analysis), however, there were no significant differences in this respect. Increasing the number of patients can yield significant results regarding these parameters. It was found in previous studies that abdominal drainage increases postoperative peritoneal inflammatory response. ¹⁵ Moreover, drains can be the source of a complication themselves. ¹⁶ There is no clear evidence regarding the requirement of routine drain use after colorectal surgery, cholecystectomy, gastric cancer surgery, and pancreatic surgery. In these procedures, it is considered that drain use depends on the initiatives and beliefs of the surgeons, rather than on scientific evidence.

In the present study, staple line leak was detected in one patient in the drain group. Drain did not provide an advantage for the diagnosis in this patient. Leaks are among major complications following laparoscopic sleeve gastrectomy but can occur after hospitalization and drains cannot eliminate the early detection of leakage.

Conclusions

Drains are used for detecting bleeding and leakage in laparoscopic sleeve gastrectomy. The lack of high sensitivity and the fact that discharge times are incompatible with the detection of leaks with drains cause the use of routine drains is questioned. Routine use of drains in laparoscopic sleeve gastrectomy should be questioned because it limits the daily life activity, increases abdominal pain, and adversely affects patient comfort.