Bupivacaine use in the Insuflow® device during laparoscopic cholecystectomy: results of a prospective randomized double-blind controlled trial

Background

Recent evidence [Surg Endosc (2007) 21: 602–606] demonstrates that intraperitoneal bupivacaine administered as an aerosol via a special catheter is safe and significantly decreases postoperative pain in laparoscopic surgery. We currently use the Insuflow^® device (Lexion Medical) routinely to warm and humidify gas in laparoscopic surgery. The purpose of this study is to determine whether using bupivacaine instead of water in existing technology already in use (Insuflow) will result in decreased postoperative pain, without increasing operative time or cost.

Methods

Using a double-blind methodology, 50 patients undergoing elective outpatient laparoscopic cholecystectomy were randomized to a study drug: either 10 ml of 0.5% bupivacaine (50 mg) or 10 ml of sterile water. The study drug was injected into the Insuflow in the standard fashion and the operation commenced routinely. No perioperative nonsteroidal anti-inflammatory drugs were used. Using a standard 0–10 pain-scoring scale, patients were assessed by perioperative nurses at 1 and 2 h postoperatively. Pain was again assessed at 24 h by telephone interview, along with the number of narcotic oral analgesics used in the first 24 h.

Results

Fifty patients were randomized, 25 in each group; the groups were comparable. All patients completed the study and 100% follow-up was obtained. All patients were discharged the same day and there were no significant complications in either group, and specifically no complications attributed to bupivacaine or use of the Insuflow device. There were no differences in pain at 1 and 2 h. There was less pain in the bupivacaine group at 24 h, but this was not statistically significant (P = 0.055).

Conclusions

Bupivacaine use in the Insuflow device is safe. No significant differences in postoperative pain were noted in this study compared to using water.     

Is intraperitoneal levobupivacaine with epinephrine useful for analgesia following laparoscopic cholecystectomy? A randomized controlled trial

BACKGROUND AND OBJECTIVE: A randomized controlled trial of patients undergoing laparoscopic cholecystectomy. To evaluate whether the instillation of levobupivacaine, with epinephrine, intraperitoneally, reduces morphine consumption; further, to consider the degree of abdominal and shoulder pain in the presence of local anaesthetic at the site of surgical incision. METHODS: Patients received a standardized procedure and were allocated randomly to receive either (a) 2.5 mg mL(-1) levobupivacaine 30 mL, with epinephrine 5 microg mL(-1), or (b) normal saline 30 mL, with epinephrine 5 microg mL(-1), to the bed of the gall bladder and above the liver, immediately before wound closure. RESULTS: Median (interquartile range) total abdominal pain during inspiration in the levobupivacaine group was significantly (P = 0.041) lower (71 (21-129) mm) than that in the placebo group (123 (71-179) mm). However, there was no significant difference between the two groups with respect to total abdominal pain at rest, right shoulder pain or the consumption of rescue morphine and rescue dihydrocodeine. There were no differences between the two groups with respect to the administration of cyclizine, total nausea and total sedation scores. In addition, the number of episodes of vomiting was not significantly different. CONCLUSIONS: Intraperitoneal administration of levobupivacaine with epinephrine is associated with modest analgesia following laparoscopic cholecystectomy.     

Is there a role for drain use in elective laparoscopic cholecystectomy? A controlled randomized trial

Background

Although the issue of drain use in open cholecystectomy has been adequately addressed by prospective randomized trials, there is lack of evidence on the usefulness of drains in elective laparoscopic cholecystectomy, and the surgeons follow their beliefs and bias on this debate. Therefore, a controlled randomized trial was designed to assess the value of drains in elective laparoscopic cholecystectomy.

Methods

During a 5-year period (January 2002 to December 2006), 284 patients were randomized to have a drain placed (group A), whereas 281 patients were randomized 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, and hospital stay between the 2 groups.

Results

There was no mortality in either group and no statistically significant difference in morbidity or hospital stay between the 2 groups. However, postoperative pain was significantly increased in patients who had a drain placed; median visual analog scale (VAS) score was 5 (range 1 to 8) versus 3 (range 1 to 8), in the non-drained group (P < .0001). Interestingly, in 2 of 3 patients in whom a drain was placed against randomization because of bile leak suspicion, a bile leak occurred.

Conclusions

The routine use of a drain in elective laparoscopic cholecystectomy has nothing to offer; in contrast, it is associated with increased pain. It would be reasonable, however, to leave a drain if there is a worry about an unsolved or potential bile leak, bearing in mind that drain placement, although sometimes providing a false sense of security, does not guarantee either prevention or treatment of postoperative bile collections, bleeding, or bile peritonitis.     

Minicholecystectomy vs conventional cholecystectomy: A prospective randomized trial—Implications in the laparoscopic era

The objective of this study was to compare results of elective open conventional cholecystectomy (CC) to those of minicholecystectomy (MC). A clinical prospective, randomized trial was designed. The setting was an academic general surgical unit. In the CC group were 26 patients; in the MC group were 24 patients. In the CC group a conventional open cholecystectomy was performed through a subcostal incision; in the MC group operation through an initial 5-cm subcostal incision was done. Mean length of wound was 14.4 cm and 5.4 cm in the two groups, respectively (p<0.001). Mean operative time was 60 and 59 minutes, respectively. Mean operative difficulty, estimated on a 1–10 scale, was 3.4 and 5.6, respectively (p<0.05). Mean postoperative analgesia requirements (number of doses of 10 mg morphine sulphate) were 5.8 and 4.0, respectively (p=0.002). Mean duration of hospitalization was 4.7 and 3.0 days, respectively (p<0.001). Mean overall patient satisfaction, estimated on 1–10 scale, was 6 and 8.3, respectively (p=0.002). We conclude that Minicholecystectomy offers less pain, earlier recovery, and better cosmetic results than the conventional open procedure. Published results of MC compare favorably with those of laparoscopic procedures. The implications of these results in the laparoscopic era are discussed.

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ResumenObjetivo comparar los resultados de la colecistectomía convencional abierta (CC) con los de la minicolecistectomía (MC).Diseño ensayo clínico prospectivo randomizado en una unidad académica de cirugía general.Sujeto grupo CC de 26 pacientes, MC de 24. Intervenciones: colecistectomía por incisión subcostal en la CC y por incisión subcostal de 5 cm en la MC.Resultados las longitudes promedio fueron 14.4 cm y 5.4 cm (p<0.001); los tiempos operatorios promedio fueron 60 y 59 minutos respectivamente; la dificultad técnica promedio fue calificada como 3.4 y 5.6 en una escala de 1–10, respectivamente (p<0.05); los requerimientos postoperatorios de analgesia (número de dosis de 10 mg de sulfato de morfina) fueron 5.8 y 4.0 (p<0.002); los días de hospitalización fueron de 4.7 y 3.0 dias, respectivamente (p<0.001); el grado de satisfacción del paciente fue estimado en 6 y 8.3 sobre una escala de 1–10 (p=0.002).Conclusion la MC se asocia con menos dolor, recuperación más temprana y mejor resultado estético que la operación convencional abierta. La literatura presenta resultados comparativamente favorables entre MC y los procedimientos lapascópicos. Se discuten las implicaciones de ello en la era laparoscópica.

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RésuméObjectif comparer les résultats de la cholécystectomie traditionnelle (CT) à la cholécystectomie par minilaparotomie (CM).Type d'étude clinique, prospective, randomiséeLieu Unité de soins universitaireMalades 26 patients ayant eu une CT, 24 ayant eu une CMInterventions La CT a été réalisée par une incision souscostale, la MC, à travers une incision sous-costale de 5 cm.Résultats La longeur moyenne de l'incision de la CT a été de 14.4 cm et celle de la CM de 5.4 cm (p<0.001). La durée moyenne des interventions a été respectivement de 60 et de 59 minutes. La difficulté de l'intervention, évaluée sur une échelle de 1 à 10 a été respectivement de 3.4 et de 5.6 (p<0.05). Les besoins moyens d'analgésie postopératoire (nombre de doses de sulphate de morphine, 10 mg) ont été respectivement de 5.8 et de 4.0 (p=0.002). La durée moyenne de l'hospitalisation a été respectivement de 4.7 et de 3.0 jours (p<0.001). L'évaluation des soins par les patients, notée de 1 à 10, a été respectivement de 6 et de 8.3 (p=0.002).Conclusions La CM est moins douleureuse, permet une récupération plus précoce et donne un meilleur résultat esthétique. Ces résultats sont comparables à ceux de la littérature. Les implications de ces résultats, à l'heure de la cholécystectomie laparoscopique, sont discutées.

     

Nortriptyline for treating enuresis in ADHD—a randomized double-blind controlled clinical trial

Background

Treating enuresis in children with attention deficit hyperactivity disorder (ADHD) has not been previously reported. This study aims to investigate the efficacy, tolerability, and adverse effects of nortriptyline for treating enuresis in children with ADHD.

Methods

Forty-three children aged from 5 to 14?years old were randomized into two groups. The treatment group received methylphenidate plus nortriptyline, while the placebo group received methylphenidate plus placebo. Nortriptyline and placebo were administered for 30?days and methylphenidate was administered for 45?days. The major outcome measure was parent-reported frequency of enuresis for 2?weeks prior to the intervention, during the intervention, and for 2?weeks after stopping the adjuvant therapy. Adverse effects were also checked.

Results

While nortriptyline statistically decreased the incidence of nocturnal enuresis during the intervention, the number of enuresis events did not significantly change in the placebo group. In addition, enuresis was not different from the baseline frequency of enuresis after stopping nortriptyline or placebo administration. Both nortriptyline and placebo were tolerated well.

Conclusions

Administration of nortriptyline for treating enuresis in ADHD has not been investigated before. Nortriptyline is statistically superior to placebo. However, enuresis will relapse after stopping nortriptyline in children with ADHD who continue taking methylphenidate.     

A prospective, randomized, single-blind trial of 5-mm versus 3-mm ports for laparoscopic cholecystectomy: is smaller better?

Background

Single-incision laparoscopic cholecystectomy (SILC) is said to provide improved cosmesis with a reduction in postoperative pain, but SILC involves a change in operative technique. A single-blind, randomized controlled trial compared cosmetic outcomes and postoperative pain between 3- and 5-mm ports used for laparoscopic cholecystectomy (LC).

Methods

For this study, 80 patients with symptomatic gallstones were recruited from a single center and randomized to a LC using either a 5-mm port and three 3-mm ports (group A) or a 10-mm port and three 5-mm ports (group B). Operative details; pain scores at 1 h, 6 h, and 1 week; and analgesia required during the first week were collected. Cosmetic outcome was assessed at 6 months using a validated questionnaire.

Results

For each group, 40 patients were recruited. The two groups were well matched except for sex. Group A had 11 males, and Group B had 4 males. The mean operative time was 49 ± 12 min (range, 24–120 min) in the 3-mm group versus 46 ± 19 min (range, 21–124 min) in the control group (p = 0.40). The two groups did not differ statistically in the day case rate. The pain scores in Group A were 2.5 ± 2.1 at 1 h, 3.2 ± 2.2 at 6 h, and 0.8 ± 2.2 at 1 week versus 4.2 ± 2.9 at 1 h, 3.3 ± 2.4 at 6 h, and 2.1 ± 2.4 at 1 week in Group B (p = 0.003, 0.63, and 0.002, respectively). No difference in the analgesia consumption was observed during the first postoperative week. The patients in Group A had significantly better cosmetic outcome scores at 6 months.

Conclusion

The use of 3-mm ports is technically feasible in patients undergoing LC for gallstones. The operating times are comparable with those for conventional LC, whereas the pain scores are reduced, and the cosmetic outcome is better.     

Effectiveness for pain after laparoscopic cholecystectomy of 0.5% bupivacaine-soaked Tabotamp® placed in the gallbladder bed: a prospective, randomized, clinical trial

Background

Some scientific studies, with controversial results, have evaluated the efficacy in reducing pain of some different local anesthetic molecules, which were administered at different dosages and in different ways. The primary goal of this randomized, controlled, prospective study (Clinical Trials.gov ID NCT00599144) was to assess the effectiveness of 0.5% bupivacaine for pain control after video-laparoscopic cholecystectomy at its optimal dosage of 2 mg/kg infiltrated in the muscular fasciae of the trocars, or positioned in the gallbladder soaking a sheet of regenerated oxidized cellulose (Tabotamp^®).

Methods

A total of 45 patients underwent elective video-laparoscopic cholecystectomy. They were randomized in three groups each made of 15 patients: group A (bupivacaine-soaked Tabotamp^® positioned in the gallbladder bed), group B (bupivacaine infiltrated in the muscular fasciae of the trocars’ seat), group C (control group, not using local anesthetic). Six and twenty-four hours after the intervention, the nature of the pain and its intensity were recorded with the use of a Visual Analogue Scale (VAS).

Results

Six hours after the intervention, VAS average was 29.6 ± 10.92 for group A, 25.86 ± 16.06 for group B, and 36.13 ± 16.62 for group C. At 24 h, we recorded 19.26 ± 15.81, 18.53 ± 12.3, and 20.46 ± 20.08 for groups A, B, and C, respectively (p > 0.05). Comparing groups A and B between them and with the control group at 6 and 24 h, we deduced how only the first group showed a statistically significant advantage (p < 0.05) in reducing visceral and shoulder pain compared with the two other groups. Wound infiltration resulted in being statistically favorable in reducing parietal pain only when compared with Group A. For groups A and B, bupivacaine significantly reduced the use of postoperative pain killers.

Conclusion

Bupivacaine, either infiltrated in trocars’ wounds or kept soaked in a regenerated oxidized cellulose sheet positioned in the gallbladder bed, although safe and not economically demanding, can increase postoperative comfort.     

Lateral internal sphincterotomy versus 0.25 % isosorbide dinitrate ointment for chronic anal fissures: a prospective randomized controlled trial

Purpose

To compare the healing properties of lateral internal sphincterotomy (LIS) and isosorbide dinitrate (ISDN) ointment for chronic anal fissure.

Methods

Patients with a chronic anal fissure were randomly assigned to a group treated with ISDN ointment (n = 105) or a group treated with LIS (n = 102). The same investigators examined the patients in a blinded manner, 1, 2, 3, 6, and 12 months after the treatments.

Results

The anal fissure had healed completely by 4 weeks in 64.7 versus 92.2 %, and by 6 months in 77.1 versus 97.1 % of the ISDN and LIS group patients, respectively. At 12 months, the recurrence rates were 4.8 versus 1 % for the ISDN and LIS groups, respectively, and the success rates of the treatments were 72.4 versus 96.1 %, respectively. Six patients in the LIS group experienced minor fecal incontinence, and seven (6.7 %) patients in the ISDN group experienced headaches that responded well to paracetamol.

Conclusion

ISDN ointment was reported by all patients to be easy to use. Although its success rate was lower than that of surgery, ISDN can be offered to selected patients with a chronic anal fissure, as it has a low recurrence rate and rare side effects are rare.     

Optimizing treatment strategies in myeloma cast nephropathy: rationale for a randomized prospective trial

Renal failure is a frequent complication of multiple myeloma (MM) that strongly affects patient survival. Although a variety of renal diseases may be observed in MM, myeloma cast nephropathy (MCN), a tubulo-interstitial disorder related to precipitation of a monoclonal light chain (LC) within tubular distal lumens, is the main cause of severe and persistent renal failure. To date, the respective frequency and initial evolution of renal disorders associated with monoclonal LC in MM remain poorly defined. Treatment of MCN relies on urgent symptomatic measures and rapid introduction of chemotherapy to reduce the production of monoclonal LC. The introduction of novel chemotherapy regimens based on the association of bortezomib with dexamethasone is likely to have improved the prognosis of MM patients with renal failure. In addition, the combination of novel agents with efficient removal of circulating LC through high cut-off hemodialysis membrane may further increase renal response rate. However, the impact on patient and renal outcomes of these potential therapeutic advances has not been evaluated in prospective studies. The randomized trials EuLITE in the UK and Germany and MYRE in France should help to answer these issues. MYRE is a randomized controlled phase III trial (NCT01208818) that aims to better define the epidemiology and typology of inaugural renal failure in MM and to optimize therapy of MCN patients with and without dialysis-dependent renal failure.     

Inflammatory response after laparoscopic and conventional colorectal resections – results of a prospective randomized trial

Background: Short-term benefits of laparoscopic relative to conventional colorectal resections have been demonstrated in randomized controlled trials. It has been suggested that a diminished cytokine and acute-phase response may be responsible for these advantages. Methods: In a randomized controlled trial, patients underwent laparoscopic (n=30) or conventional (n=30) resection of colorectal tumors. Plasma levels of interleukin-1 receptor antagonist (IL-1RA), interleukin-6 (IL-6), interleukin-10 (IL-10), and C-reactive protein (CRP) were analyzed repeatedly. Postoperative peak levels and area under the curve values were calculated and compared between groups using the Mann-Whitney U-test. Results: Patient characteristics, preoperative cytokine, and CRP plasma levels were not different between each group. Postoperative peak concentrations of IL-6 (P=0.05) and CRP (P<0.001) and the overall postoperative plasma concentrations of IL-6 (P=0.03) and CRP (P=0.002) were lower in the laparoscopic than in the conventional group. Peak and overall IL-1RA (P=0.2; P=0.2) and IL-10 (P=0.4; P=0.6) plasma concentrations, respectively, were not different between groups. Conclusions: IL-6 and CRP plasma levels were lower after laparoscopic than conventional colorectal resections. The less intense inflammatory response may be an indicator of the milder surgical trauma inflicted by laparoscopic than conventional colorectal resection. Received: 31 March 1999; in revised form: 15 July 1999 Accepted: 20 August 1999     

The impact of dexamethasone as a perineural additive to ropivacaine for PECS II blockade in patients undergoing unilateral radical mastectomy – A prospective,randomized, controlled and double-blinded trial

Study objectiveDexamethasone is commonly used as an adjuvant to local anesthetics to prolong duration of peripheral nerve blocks with minimal side-effects. The present study investigates the efficacy of dexamethasone added to ropivacaine 0.2% as compared to ropivacaine 0.2% alone for pectoral nerves block II (PECS II) in unilateral radical mastectomy.DesignA prospective, randomized, controlled and double-blinded trial.SettingThe study was performed at Innsbruck Medical University Hospital, Austria, between January 2019 and October 2020.PatientsSixty female patients with an American Society of Anesthesiologists Score I-II (18–90 years, BMI 18–35) scheduled for unilateral radical mastectomy without one-stage immediate autologous breast reconstruction were randomly assigned to receive PECS II block with ropivacaine 0.2% with or without dexamethasone 8 mg.InterventionsPatients were randomly assigned to receive PECS II block with ropivacaine 0.2% with or without dexamethasone 8 mg.MeasurementsPrimary outcome parameter was the cumulative opioid consumption during the first 72 postoperative hours. Secondary outcome parameters were the duration of analgesia and the course of the visual analogue scale (VAS) and the area under the curve VAS (AUC-VAS).Main resultsThere was no difference in cumulative opioid consumption after 72 h between the ropivacaine 0.2% plus dexamethasone group and the ropivacaine 0.2% plus placebo group (11.89 vs 11.90 morphine milligram equivalent, respectively; p 0.831). Duration of analgesia also did not differ significantly between the ropivacaine 0.2% plus dexamethasone group and the ropivacaine 0.2% plus placebo group (12.75 versus 8.75 h, respectively; p 0.680). There also was no difference in the course of VAS and AUC-VAS.ConclusionsDexamethasone 8 mg when added to ropivacaine 0.2% for PECS II block in unilateral radical mastectomy was not found to reduce total opioid consumption over 72 postoperative hours or to prolong duration of analgesia as compared to pure ropivacaine 0.2%.     

Is antibiotic prophylaxis required for flexible cystoscopy? A truncated randomized double-blind controlled trial

PURPOSE: To examine the incidence of urinary tract infection (UTI) after flexible cystoscopy (FC) and determine whether prophylactic norfloxacin reduces this incidence compared with placebo. Patients and METHODS: A double-blind trial was performed, randomizing 234 patients to either 400 mg of norfloxacin or placebo prior to FC. All patients provided a midstream urine specimen (MSU) before the procedure, as well as at day 3 and day 7 after FC. In addition, a telephone questionnaire was performed to correlate the nature and severity of any symptoms associated with UTI. RESULTS: Interim analysis was performed because of the low recruitment rate, and a significantly lower infection rate than expected meant that the trial was discontinued. There was one symptomatic UTI in the placebo group (0.82%) and one in the norfloxacin group (0.89%). The UTI in the placebo group was de novo, while the infection in the norfloxacin group was secondary to pre-FC bacteriuria. There was no difference in the infection rates in the two groups. The overall infection rate (de novo and secondary to existing bacteruria) after FC was 0.85%. CONCLUSION: Infection after flexible cystoscopy is rare and not associated with significant morbidity. A much larger study would be required to determine whether antibiotic prophylaxis significantly reduces the rate of postprocedure UTI.     

Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications

Background

The fundoplication of choice for the surgical treatment of gastroesophageal reflux disease (GERD) still is debated. Multichannel intraluminal impedance monitoring (MII) has not been used to compare objective data, and comparative subjective data on laparoscopic Nissen and Toupet fundoplications are scarce.

Methods

This study randomly allocated 125 patients with documented chronic GERD to either laparoscopic floppy Nissen fundoplication (LNF; n = 62) or laparoscopic Toupet fundoplication (LTF; n = 63). The Gastrointestinal Quality of Life Index (GIQLI), symptom grading, esophageal manometry, and MII data were documented preoperatively and 1 year after surgery. The pre- and postprocedure data were compared. Statistical significance was set at a p value lower than 0.01 (NCT01321294).

Results

Both procedures resulted in significantly improved GIQLI and GERD symptoms. Preoperative dysphagia improved in both groups, but the improvement reached significance only in the LTF group. The ability to belch was shown to be significantly more decreased after LNF than after LTF. Gas-bloat and “atypical” extraesophageal symptoms also were decreased after surgery (p < 0.01). However, bowel symptoms were virtually unchanged in both groups. Both procedures resulted in significantly improved lower esophageal sphincter pressures. The improvement was greater in the LNF group than in the LTF group (p < 0.01). The DeMeester score and the numbers of total, acid, proximal, upright, and recumbent reflux episodes decreased in both groups after surgery (p < 0.01). No significant difference between the procedures in terms of MII data was found. Six patients (4.8 %) had to undergo reoperation because of intrathoracic slipping of the wrap. All the patients had undergone LNF.

Conclusions

Both procedures proved to be equally effective in improving quality of life and GERD symptoms. However, the reoperation and dysphagia rates were lower and the ability to belch was higher after LTF than after LNF.     

Is bowel preparation before excretory urography necessary? A prospective, randomized, controlled trial

PURPOSE: A prospective, randomized, single blind, controlled trial was performed to determine whether routine bowel preparations are necessary for satisfactory visualization of the urinary system during IVP and compare the side effects of several bowel preparation methods. MATERIALS AND METHODS: A total of 200 patients between 17 and 70 years old at the outpatient department who were prescribed IVP were enrolled in this prospective study. Patients were divided into 4 groups and randomly received liquid supper, senna, magnesium sulfate solution and PEG-ELS as bowel preparation before IVP. Control and contrast images were assessed by a radiologist and a urologist blinded to the bowel preparation. IVP was given a visualization score, a fecal residue score, a bowel gas score and an overall quality score. Images were also divided into anatomical sections to assess visualization, and the effect of fecal residue and bowel gas. Questionnaires were prepared about the side effects of bowel preparation. RESULTS: For contrast images there was no significant difference in terms of visualization,, fecal residue, bowel gas and overall quality scores among the 4 groups. The same result was seen on the control image except for fecal residue scores, when the senna and PEG-ELS groups had a lower fecal residue score than the liquid supper group (p = 0.001). Interestingly when considering sectional images, the right renal region of the control image showed that the senna and PEG-ELS groups had better visualization scores with less bowel gas and fecal residue than the liquid supper only group. Patients in all 3 laxative bowel preparation groups except the liquid supper group reported side effects. There was no statistically significant difference among these 3 groups in the attitude toward ingesting laxatives again. CONCLUSIONS: Our results suggest that routine bowel preparation prior to IVP does not improve the visibility or overall quality of control or contrast images, while patients experience certain side effects due to the bowel preparation. The laxative bowel preparation may be helpful only when visualizing the right renal region on the control image.     

Transvaginal hybrid NOTES cholecystectomy—results of a randomized clinical trial after 6 months

Introduction

For cholecystectomy (CHE), both the needlescopic three-trocar technique with 2–3-mm instruments (needlescopic cholecystectomy (NC)) and the umbilically assisted transvaginal technique with rigid instruments (transvaginal cholecystectomy (TVC)) have been established for further reduction of the trauma remaining from laparoscopy.

Methods

To compare the further outcome of both techniques for elective CHE in female patients, we analyzed the secondary end points of a prospective randomized single-center trial (needlescopic versus transvaginal cholecystectomy (NATCH) trial; ClinicalTrials.gov Identifier: NCT0168577), in particular, satisfaction with aesthetics, overall satisfaction, abdominal pain, and incidence of trocar hernias postoperatively at both 3 and 6 months. After 3 months, the domains “satisfaction” and “pain” of the German version of the Female Sexual Function Index (FSFI-d) were additionally evaluated to detect respective complications. A gynecological control examination was conducted in all TVC patients after 6 months.

Results

Forty patients were equally randomized into the therapy and the control groups between February 2010 and June 2012. No significant differences were found for overall satisfaction with the surgical result, abdominal pain, sexual function, and the rate of trocar hernias. However, aesthetics were rated significantly better by TVC patients both after 3 and after 6 months (P?=?0.004 and P?<?0.001). There were no postoperative pathological gynecological findings.

Conclusions

Following TVC, there is a significantly better aesthetic result as compared to NC, even at 3 and 6 months after the procedure. No difference was found for sexual function.