Less pain after transvaginal cholecystectomy: single-center pooled analysis.

BACKGROUND: We previously reported outcome after transvaginal cholecystectomy (TVC) from two cohort studies and a randomized controlled trial. We now present a pooled analysis of postoperative pain scores. DESIGN: Single-center data of postoperative pain after TVC from a level II hospital between October 2007 and June 2012. METHODS: Female patients, above 18 years with symptomatic cholecystolithiasis, received either TVC or conventional laparoscopic cholecystectomy (CLC). Follow up 4 days. The primary outcome of the study was pain after surgery. Pain was measured via a visual rating scale. Descriptive statistics include age, body mass index (BMI), ASA grade, surgical times, number of trocars, complications and hospital stay as well as pain medication. Pain data were assessed against histologic findings. RESULTS: The combined register included 316 patients. Of these, 7 patients were excluded from analysis due to conversion to open surgery, complications and denial of follow-up. There were 141 patients in the TVC and 168 in the CLC group. There was no difference in age, ASA grade, surgical times, complications or hospital stay. BMI was significantly different with an average BMI of 27.1 in the TVC and 28.7 in the CLC group (p = 0.027). The numbers of trocars were significantly different as expected. There was no difference in postoperative pain medication. Pain scores were significantly different on day two to four. Multivariate testing revealed no dependence between postoperative pain and histologic findings. CONCLUSION: On smaller patient numbers, we were previously unable to demonstrate a consistently, significant difference for postoperative pain in our cohort and randomized studies. The pooled analysis suggests that there is an advantage with less postoperative pain after transvaginal compared to standard laparoscopic cholecystectomy.

Comprehensive complication index for NOTES procedures: results from a randomized controlled trial and comparison to published NOTES complication data.

OBJECTIVE: This investigation uses the comprehensive complication index (CCI) to compare complications after natural orifice transluminal endoscopic surgery (NOTES) procedures. BACKGROUND: NOTES procedures are developed to miniaturize surgical trauma. NOTES publications inconsistently report complications. The CCI improves reporting of complications. METHODS: The CCI is calculated using complication data from a single center, double blind, randomized controlled trial comparing transvaginal [transvaginal cholecystectomy (TVC), N = 41] and conventional laparoscopic cholecystectomy (CLC, N = 51). Complications are assessed using the classification of surgical complications (CSC). Two different scenarios are applied to the CSC for definition of complications with an emphasis on minor complications. CSC data are fed into the free online CCI-calculator. The CCIs from complication data from other NOTES reports are calculated accordingly and compared to our results. RESULTS: The CCI allows easy indexing of complications with or without a CSC table. For scenario I, the mean CCI of CLC versus TVC is 3.3 (± 6.3; SD) versus 3.5 (± 6.4; n.s.) and for scenario II it is 7.6 (± 6.4) versus 6.5 (± 7.0; n.s.). The difference of the mean between the two scenarios is highly significant (p < 0.000). The mean CCIs of both groups and scenarios are below the CCI of 8.7 for a grade I CSC complication. Similar calculation of CCIs from other NOTES publications yields mean CCIs below 8.7 for the surgical procedures reported. CONCLUSION: The CCI results in a single, easily comparable complication index for surgical procedures whereas the CSC yields tabular results. A significant difference in interpretation occurs with variation in definition of complications. Average CCIs below a value of 10 describe low complication rates. Authors need to describe their definition of complications if using the CSC and the CCI. More emphasis should be given to reporting of minor complications. The use of the CCI for NOTES procedures will enable international comparison.

Postoperative pain after transvaginal cholecystectomy: single-center, double-blind, randomized controlled trial.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) has the potential to reduce postoperative pain. We compared postoperative pain in the hybrid NOTES procedure transvaginal video-assisted cholecystectomy (TVC) with standard conventional laparoscopic cholecystectomy (CLC). DESIGN: Single-center, double-blind, randomized controlled trial in a level II hospital between June 2008 and June 2012. METHODS: Female patients, older than 18 years of age with symptomatic cholecystolithiasis were randomized to receive either TVC or CLC. The follow-up period was 7 days and the primary outcome of the study was postoperative pain. We hypothesized that there is no reduction of pain (Visual Rating Scale ≥1) while resting or coughing over a 48-h period after the operation. Secondary outcome included wound infections, complications, and patient reported outcomes. Sealed envelopes with computer-generated randomization information were kept for allocation in theater. All patients received opaque wound dressing, as in standard four-trocar cholecystectomy and a vaginal tamponade. Theater protocol and surgical notes were kept separate after the procedure. RESULTS: Overall, 97 of 426 patients assessed for participation were randomized for either TVC or CLC. A total of 41 patients had a TVC and 51 had a CLC. Five patients were excluded from the analysis. There was no difference in age, body mass index, American Society of Anesthesiologists (ASA) grade, or hospital stay, but anesthetic and surgical times were significantly longer in TVC (p < 0.001). There was no statistical difference in postoperative pain between the two groups while resting or coughing. Complications included conversion to laparotomy, bleeding, wound infections, and re-admission. No difference in the rate of complications between the two groups was seen. Overall, 86 and 93% of CLC and TVC patients, respectively, would recommend the procedure to other patients. CONCLUSION: In this study, no significant difference in pain on days 1 and 2 postoperatively between the two methods was found. The safety profile of TVC is comparable to CLC, and TVC patients would generally recommend this procedure to other patients.

Prospective evaluation of transvaginal assisted cholecystectomy.

BACKGROUND: Transvaginal video-assisted cholecystectomy (TVC) has so far not been prospectively evaluated using an internationally recognized health-related quality of life (HRQoL) assessment. We report the results of a prospectively studied cohort of patients with clinical and quality of life data. METHODS: Prospectively controlled study of 128 patients undergoing TVC and 147 patients with conventional laparoscopic cholecystectomy (CLC). Data reported include patient demography, body mass index, anesthetic risk score (ASA), laboratory data, surgical times, length of hospital stay, pain score, analgesic medication used, complications, and quality of life scores using the combined method of SF-36 and GIQoL. RESULTS: Ninety-five TVC and 96 CLC patients fully completed pre- and postoperative HRQoL questionnaires. Patients with incomplete or missing questionnaires were excluded as well as patients with signs of acute cholecystitis. Differences included cardiovascular comorbidity and previous surgical procedures, but there was no difference in age (p = 0.4), body mass index (p = 0.4), ASA grade (p = 0.4), or preoperative quality of life. No difference was seen in laboratory data, surgical times, or length of hospital stay. Pain score and analgesic medication showed a clear trend and significant differences in favor of TVC. There was no difference in complications. Quality of life and postoperative sexual function did not show any differences between the two groups. CONCLUSIONS: This is the first study to report HRQoL outcomes after TVC using a recognized combined HRQoL assessment method. Although differences do exist in patient comorbidity and previous surgical experience, both groups were comparable. Less postoperative pain and no difference in HRQoL in TVC patients underlines this new procedure as a feasible standard approach in female patients. This study also is the first to differentiate between acute cholecystitis and symptomatic cholecystolithiasis in patients undergoing TVC.

The barrier-free trocar technique in three laparoscopic standard procedures.

BACKGROUND: Numerous technical and surgical innovations took place in laparoscopic surgery in the recent past. It is debatable whether single-access surgery or natural orifice surgery (NOS) will establish for several standard procedures. Most of the NOS-procedures are controversial and single-access surgery still has to prove its equality in controlled trials. In the intention to reduce the ingress incisons and to facilitate instrumentation, we decided to test the barrier-free AirSeal(®)-trocar in clinical practice. MATERIALS AND METHODS: Laparoscopically we performed a cholecystectomy, gastric wedge-resection and a fundoplication using the barrier-free AirSeal(®) 12-mm-trocar. This trocar works without any mechanical barrier so that via this trocar the use of two instruments is possible. RESULTS: All three operations were successful. CONCLUSION: Laparoscopic standard procedures are feasible using this barrier-free trocar without a higher degree of difficulty. Because of the facilitated instrumentation, it is possible to work more efficiently and to maintain the focus on the surgical field.

Transvaginal video-assisted cholecystectomy in clinical practice.

BACKGROUND: Transvaginal video-assisted cholecystectomy with rigid instruments is a new procedure that combines natural orifice surgery (NOS) with classic laparoscopy. This hybrid technique requires conventional laparoscopy via an umbilical incision. To date it is unclear if this procedure is safe and feasible in routine practice. METHODS: We report on a case series of 128 women who consented to transvaginal cholecystectomy. Data, including visual analog scores (VAS), were collected prospectively via a standard digital spreadsheet. Patients completed satisfaction questionnaires within 10 days after discharge from hospital. We report on outcomes, age, body mass index, operating time, complications, pain scores, and patient satisfaction. RESULTS: In 115 (89.8%) patients the procedure was performed as a transvaginal operation. In 11 women (8.6%), we converted to standard laparoscopy, and in 2 cases (1.6%), we converted to an open procedure. Mean age was 52.4 years (range = 23-78 years) and mean body mass index was 27.8 (range = 18.8-42). Mean operating time was 60.6 min (range = 22-110 min). Other procedures were combined with hybrid cholecystectomy in six cases. Complications following transvaginal access included one vaginal bleeding, one perforation of the urinary bladder, and one superficial lesion of the rectum. In one case the hepatic duct had to be stented due to leakage after the procedure via endoscopic retrograde cholangiography. Mean VAS on day 1 was 2.26 (± 0.31 SEM) and on day 2 it was 1.53 (± 0.35 SEM). In a postoperative questionnaire, 95% of patients indicated that they would recommend this procedure to other patients. CONCLUSIONS: Transvaginal cholecystectomy is a safe and easy-to-learn procedure. Possible complications are different than those of standard laparoscopic procedures. Trauma to the abdominal wall and scarring is minimal. Postoperative pain scores were not different than those of standard laparoscopy and a high percentage of patients are satisfied with the procedure.