Langenbecks Arch Surg (2014) 399:717–724 DOI 10.1007/s00423-014-1218-2
CONTROLLED CLINICAL TRIAL
Transvaginal hybrid NOTES cholecystectomy—results of a randomized clinical trial after 6 months Dirk Rolf Bulian & Jurgen Knuth & Nicola Cerasani & Jonas Lange & Michael Alfred Ströhlein & Axel Sauerwald & Markus Maria Heiss
Received: 24 April 2014 / Accepted: 15 June 2014 / Published online: 22 June 2014 # Springer-Verlag Berlin Heidelberg 2014
Abstract 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.
The trial is supported, in part, by the German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01-GH-0605). D. R. Bulian (*) : J. Knuth : N. Cerasani : J. Lange : M. A. Ströhlein : M. M. Heiss Department of Abdominal, Vascular and Transplant Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Ostmerheimer Strasse 200, 51109 Cologne, Germany e-mail:
[email protected] J. Knuth Department of General, Visceral, Vascular and Thoracic Surgery, Clinic of Kempten, Robert-Weixler-Strasse 50, 87439 Kempten, Germany A. Sauerwald Department for Obstetrics and Gynecology, Holweide Hospital, Neufelder Strasse 32, 51067 Cologne, Germany
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. Keywords Transvaginal cholecystectomy . Needlescopic cholecystectomy . NOTES . Satisfaction with aesthetic result . Sexual function
Introduction Operative procedures are supposed to cure diseases or alleviate symptoms. In addition, they should entail as few disadvantages for the patient as possible. All operative procedures on intraabdominal organs require access to the abdominal cavity. For a long time, the standard access was by means of laparotomy. However, this access through the abdominal wall causes a relevant part of the surgical trauma and is responsible for a majority of surgical intra- and postoperative complications including postoperative pain, wound infections, open abdomen, and incisional hernias, as well as aesthetic consequences such as scar appearance following the operation. Laparoscopy was developed in order to minimize the risks and aesthetic consequences of access-related trauma. Needlescopic or minilaparoscopy utilizes instruments and optics with a diameter of less than 4 mm. It further reduces trauma and scarring as compared to conventional laparoscopy,
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which results in improved aesthetics [1]. These techniques, however, still require trocar incisions and retrieval incisions with their respective complications. Furthermore, the size of the retrieval incision increases with the size of the specimen. Additionally, the concept of natural orifice transluminal endoscopic surgery (NOTES) has been developed to avoid any abdominal wall trauma and related complications. Here, transgastric, transrectal, transvesical, or transvaginal access through a natural opening and into the abdominal cavity is gained by means of controlled perforation of the corresponding hollow organ [2]. For this purpose, gender-dependent transvaginal access, long established for gynecological procedures, is frequently used [3]. However, negative mid- and long-term consequences of transvaginal access are feared for sexual intercourse in terms of dyspareunia as well as impaired satisfaction. Due to the limited availability of appropriate instruments, mainly hybrid-NOTES procedures are performed in clinical routine, meaning that apart from access through a natural orifice, at least one further trocar is placed through the abdominal wall [3]. The advantage of hybrid-NOTES procedures therefore lies mainly in the avoidance of a retrieval incision, which causes the main part of the access trauma and consecutive scarring as well as complications like incisional hernias, even in laparoscopic procedures. Evidence for an advantage of the hybrid-NOTES technique for cholecystectomy has been found for the early postoperative course both in cohort studies as well as in one prospective/ randomized study [4–6], for the later course only in nonrandomized design [7]. The secondary outcome parameters of our prospective, randomized trial (needlescopic versus transvaginal cholecystectomy (NATCH) trial; ClinicalTrials.gov Identifier: NCT0168577), 3 and 6 months postoperatively, were therefore selected to clarify whether the most frequently performed hybrid-NOTES procedure, transvaginal/ transumbilical cholecystectomy, offers an advantage in terms of postoperative aesthetics when compared to the most minimally invasive technique, namely needlescopic three-trocar cholecystectomy. Additionally, it was of interest to learn whether transvaginal cholecystectomy (TVC) patients experienced pain or reduced satisfaction during sexual intercourse when compared to the control group and whether accessrelated pathological gynecological findings became evident over time.
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instruments with the needlescopic three-trocar CHE using 3mm instruments. The study protocol was approved by the ethics committee of Witten/Herdecke University (89/2009). Eligible patients from the Department of Abdominal, Vascular, and Transplant surgery of the Cologne Merheim Medical Center were screened between February 2010 and June 2012. All patients gave written informed consent for participation in the study. We performed 336 cholecystectomies in 150 (44.6 %) male and 186 (55.4 %) female patients in the respective time period. Of the 186 procedures on female patients, there were 24 (12.9 %) emergency operations and 9 (4.8 %) cholecystectomies in the course of a separate procedure. Furthermore, there were two (1.1 %) primarily conventional cholecystectomies due to suspected malignancy. Forty of the remaining 151 patients were included in this trial, leading to a recruitment rate of 26.5 %. Twenty-seven of the 151 patients (17.9 %) refused to take part in the study, having explicitly opted for the TVC technique. Three cholecystectomies were performed as needlescopic cholecystectomy (NC) outside the scope of the presented study. One of the 111 nonincluded elective female patients needed a conversion to a conventional cholecystectomy (0.9 %). Intensity of pain in the first 48 h as a primary end point and other short-term parameters of the 40 randomized patients were analyzed and recently published [5]. Inclusion and exclusion criteria of patients are listed in the respective paper. Additionally, we defined further secondary end points over time, which were analyzed in this work. Surgical technique The TVC was performed in hybrid technique as described by Zornig using rigid, reusable instruments with patients in lithotomy position [8]. The technique for the needlescopic three-trocar cholecystectomy has been extensively described elsewhere [5]. Briefly, one umbilical 11-mm trocar and two 3.9-mm trocars, namely epigastric and right-sided subcostal, were used, and the gallbladder was retrieved through the umbilical trocar incision. The first surgeon performed all subsequent procedures (DRB) in order to rule out surgeon-related interindividual influences, on the one hand, and individual learning curves, on the other, based on preexisting experience of the first surgeon in TVC before starting the trial.
Patients and methods Outcome measures Study design and patients The NATCH is a randomized, prospective, nonblinded singlecenter study which compares the transvaginal/transumbilical hybrid-NOTES cholecystectomy (CHE) using rigid
The baseline characteristics of all patients as well as the perioperative and early postoperative results of the first 2 weeks have already been analyzed and published, whereby comparability of both study groups has been demonstrated
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Table 1 Questionnaire for data acquisition 3 months postoperatively
[5]. The secondary end points of the later course were defined as follows: patients’ satisfaction with the aesthetic postoperative result after 3 and 6 months, rated on a fivegrade ordinal scale ranging from 1 (very satisfied) to 5 (very dissatisfied), abdominal pain during activity, measured using a
Table 2 Questionnaire for data acquisition 6 months postoperatively
numeric rating scale (NRS-11) [9], satisfaction of patients with the overall procedural result, also on an ordinal scale from 1 (very satisfied) to 5 (very dissatisfied), and incidence of trocar hernias after 3 and 6 months. Furthermore, satisfaction and pain in the context of sexual intercourse were
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evaluated after 3 months, using the respective six questions of the German version of the Female Sexual Function Index (FSFI-d) [10, 11]. The domains “satisfaction” (items 14 to 16) and “pain” (items 17 to 19) were evaluated both separately and combined, in order to distill possible respective outcomes of the transvaginal access. Questioning of patients was conducted through telephone interviews 3 and 6 months postoperatively using a structured questionnaire. In case of a positive or uncertain answer concerning a trocar hernia, patients were scheduled for a clinical and sonographic exam. Additionally, all TVC patients received a gynecological reexamination 6 months postoperatively using a standardized questionnaire. It consisted of palpation, inspection with the use of a speculum, especially of the posterior vault of the vagina, and transvaginal sonography. The gynecologist also documented whether patients had complaints and whether patients had already had sexual intercourse postoperatively. A new control examination was scheduled when deemed necessary. Tables 1 and 2 depict the two questionnaires for the respective 3 and 6-month control. Table 3 depicts the six questions used from the FSFI-d. Statistical analysis Data processing and statistical analysis were done using IBM SPSS Statistics version 21. An intention-to-treat analysis was conducted. Mann-Whitney U test was used for the not normally distributed parameters. For binary parameters, Fisher’s exact test for categorical variables was used as well as Chisquared test for trend for the ordinal parameters. P<0.05 was defined as statistically significant. The study was registered in the ClinicalTrials.gov Register, ID: NCT01685775, as well as in the German Clinical Trials Register, ID: DRKS00000341. The Universal Trial Number (UTN) is U1111-1114-7386. The trial is supported, in part, by the German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01GH-0605).
Results Forty patients were recruited, randomized, and operated between February 2010 and June 2012 (20 TVC group and 20 NC group). Accordingly, data collection for all parameters was completed by December 2012. Figure 1 shows a flow diagram of the study. All patients were treated according to the study protocol so that no perprotocol analysis was necessary apart from the intention-totreat analysis. Postoperative complications in the early course of this trial have been published elsewhere [5]. No further complications were detected in the 3 or 6-month follow-up. Table 4 shows data for the outcome parameters satisfaction
Langenbecks Arch Surg (2014) 399:717–724 Table 3 Questions 14 to 19 of the German version of the Female Sexual Function Index (FSFI-d) 14. How satisfied have you been with the amount of emotional closeness during sexual activity between you and your partner (over the past 4 weeks)? □ Very satisfied (5 points) □ Moderately satisfied (4 points) □ About equally satisfied and dissatisfied (3 points) □ Moderately dissatisfied (2 points) □ Very dissatisfied (1 point) 15. How satisfied have you been with your sexual relationship with your partner (over the past 4 weeks)? □ Very satisfied (5 points) □ Moderately satisfied (4 points) □ About equally satisfied and dissatisfied (3 points) □ Moderately dissatisfied (2 points) □ Very dissatisfied (1 point) 16. How satisfied have you been with your overall sexual life (over the past 4 weeks)? □ Very satisfied (5 points) □ Moderately satisfied (4 points) □ About equally satisfied and dissatisfied (3 points) □ Moderately dissatisfied (2 points) □ Very dissatisfied (1 point) 17. How often did you experience discomfort or pain during vaginal penetration (over the past 4 weeks)? □ Almost always or always (1 point) □ Most times (more than half the time) (2 points) □ Sometimes (about half the time) (3 points) □ A few times (less than half the time) (4 points) □ Almost never or never (5 points) 18. How often did you experience discomfort or pain following vaginal penetration (over the past 4 weeks)? □ Almost always or always (1 point) □ Most times (more than half the time) (2 points) □ Sometimes (about half the time) (3 points) □ A few times (less than half the time) (4 points) □ Almost never or never (5 points) 19. How would you rate your level (degree) of discomfort or pain during or following vaginal penetration (over the past 4 weeks)? □ Very high (1 point) □ High (2 points) □ Moderate (3 points) □ Low (4 points) □ Very low or none at all (5 points) Source: Rosen et al. [10]; Berner et al. [11]
with the aesthetic and overall operative result, abdominal pain, and trocar hernias. All TVC patients were “very satisfied” with the aesthetic result of the operation both 3 and 6 months postoperatively, which was significantly better than the NC group (P=0.004
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Fig. 1 Trial flow diagram
and P<0.001). Even so, satisfaction with the overall operative result did not differ significantly. One patient of the TVC
group reported pain in the lower abdomen 3 months postoperatively with a value of 3 on the NRS-11. One NC patient
Table 4 Outcome parameters (apart from questions regarding sexual function) Variable
TVC group (n=20)
NC group (n=20)
Total (n=40)
P value
Satisfaction with the aesthetic result 3 months postoperatively (1–5)a Satisfaction with the overall result 3 months postoperatively(1–5)a Abdominal pain intensity 3 months postoperatively (NRS-11) Incisional hernias 3 months postoperatively Satisfaction with the aesthetic result 6 months postoperatively (1–5)a Satisfaction with the overall result 6 months postoperatively (1–5)a Abdominal pain intensity 6 months postoperatively (NRS-11) Incisional hernias 6 months postoperatively
1.00/1/1–1 1.2/1/1–2 0/0/0–0 0 (0 %) 1.00/1/1–1 1.15/1/1–3 0/0/0–0 0 (0 %)
1.35/1/1–2 1.3/1/1-3 0/0/0–0 0 (0 %) 1.7/2/1–3 1.25/1/1–2 0/0/0–0 0 (0 %)
1.18/1/1–2 1.25/1/1-3 0/0/0–0 0 (0 %) 1.35/1/1–3 1.2/1/1–3 0/0/0–0 0 (0 %)
0.004b 0.655b 0.317b 1.000c <0.001b 0.260b 0.317b 1.000c
a
Response options: 1=very satisfied, 2=moderately satisfied, 3=about equally satisfied and dissatisfied, 4=moderately dissatisfied, and 5=very dissatisfied b
Mann-Whitney U test(mean/median/range)
c
Fisher exact test
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complained of pain in the right upper abdominal quadrant 6 months postoperatively with an intensity of 6 on the NRS11. For evaluation of a possible umbilical trocar hernia, two NC patients were examined both clinically and with sonography after 3 and 6 months; no hernia was found. No difference was detected between the two groups, since no other patient reported a protrusion or pain at the trocar sites and thus no hernia was suspected. Only 17 TVC patients and 14 NC patients had penetrating sexual intercourse (SI), so the six FSFI-d questions applied to 31 of the 40 study patients. Interestingly, the other nine patients did not have SI in the 6 months before the CHE, either. There was no significant difference between TVC and NC for any of the domains “satisfaction” or “pain” or for their sum (Table 5). The gynecological control examination did not yield a pathological result for any patient (Table 6).
Discussion This prospective/randomized study was designed to compare the short-term and further outcome results of TVC with NC for symptomatic cholecystolithiasis. The short-term results were recently published [5]. In the subsequent course, both 3 and 6 months postoperatively, TVC patients were significantly more satisfied with the postoperative aesthetic result than NC patients. Simultaneously, there were no reports of disadvantages concerning satisfaction and pain in sexual intercourse or of pathological gynecological exams. However, patient satisfaction with the overall postoperative result was not significantly different between the two groups. Our study is the first in literature to account for an improved aesthetic result of TVC compared to a rigid needlescopic technique in a prospective/ randomized design. A possible bias lies in the fact that many patients who are open to the new concept of TVC actually insist on that very method and therefore are not recruitable. This is reflected in the mentioned numbers of TVC cases that did not take part in the study. One may even argue that patients who take part in the study are biased because they are willing to undergo a new procedure, namely TVC.
Table 6 Findings of the gynecological control examination 6 months postoperatively Variable
Yes
No
Complaints Sexual intercourse postoperatively Local finding Reexamination scheduled
0 17
20 3
0
20
Normal
Suspicious
20
0
TVC patients only; n=20
The short-term benefit of TVC compared to traditional laparoscopy or the needlescopic technique in regard to lesser postoperative pain has been shown in nonrandomized [4, 6, 12, 13]as well as prospectively randomized group comparisons [5]. Two further prospectively randomized studies compared a hybrid-NOTES technique with a rigid laparoscopic cholecystectomy [14, 15]. The first one by Noguera et al. was an underpowered three-arm so-called pilot study comparing three-trocar CHE with flexible transvaginal hybrid-NOTES CHE and flexible “hybrid transumbilical NOTES CHE.” The main limitation of this study concerning the underpowered study design has already been discussed elsewhere [16]. Furthermore, no details were given for the follow-up procedure and the amount of analgesics used. Additionally, an extra 3-mm trocar was regularly used in the right hypochondrium. This detracts from the validity of the study. In their single-center, even doubleblinded, randomized controlled trial comparing TVC with standard conventional laparoscopic CHE, Borchert et al. found no difference in postoperative pain in the 7-day follow-up [15]. However, there was less pain (up to 0.8 points; not significant) on coughing on the visual rating scale in the TVC group compared to the control group in the first six postoperative days. There were 12 surgeons in total, each operating an average of 4.9 cases in each group. Accordingly, there might be a relevant interindividual effect. This may also be the reason for the conversation rate of 10 %. The analgesic consumption and the satisfaction with the aesthetic results were not assessed in this trial nor are there results after 3 or 6 months of follow-up.
Table 5 Outcome parameters concerning the domains “satisfaction” and “pain” out of the Female Sexual Function Index 3 months postoperatively Variable
TVC group (n=17)
NC group (n=14)
Total (n=31)
P value
Domain satisfaction (questions 14–16): median (Q1–Q3)a Domain pain (questions 17–19): median (Q1–Q3)a Both domains (questions 14–19): median (Q1–Q3)c
15 (13–15) 15 (13–15) 29 (27–30)
15 (13–15) 15 (15–15) 29 (28–30)
15 (13–15) 15 (13–15) 29 (27–30)
0.756b 0.487b 0.767b
a
Feasible sum not multiplied by the domain factor: 3–15 points
b
Mann-Whitney-U Test
c
Feasible sum not multiplied by the domain factor: 6–30 points
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Apart from the documented short-term benefits of this access, two questions remain: Are patients more satisfied with the aesthetic operative result in the later course, and, by contrast, are there specific subsequent disadvantages related to the transvaginal access? Theoretically, there may be some negative consequences for sexual intercourse, e.g. dyspareunia or persistent morphologic damage of the posterior vaginal vault, which has been shown for major gynecological oncological procedures [17]. The former is feared mostly by young women when questioned about their doubts concerning transvaginal access [18–20]. Moreover, according to Kobiela et al., more than 60 % of male partners would advise a female partner against a potential transvaginal cholecystectomy, mainly for the fear of decreased sexual satisfaction [21]. These apprehensions were shown to be unfounded in several studies, but none of them was prospectively randomized, [7, 22–26].Those studies analyzed TVC patient collectives in pre- and postoperative comparison but also postoperative sexual function in a cohort comparison of TVC versus laparoscopic CHE. Since Linke et al. even found an improvement of sexual life after transvaginal hybridNOTES procedures (CHE and anterior colorectal resection) as compared to preoperatively [22], a group comparison is a sensible method to produce a valid result concerning this matter after TVC. Patients judge the outcome after surgery not only by successful treatment of the underlying disease and the well tolerated early postoperative course but also by the most obvious remains, namely the incisional scars. Reduced scarring is therefore another evidence of the advantage of the laparoscopic technique with its minimized access trauma. Recently, Bignell et al. found an aesthetic advantage for 3 mm as compared to 5-mm trocars after 6 months in a prospective, randomized, single-blinded trial [27]. However, the evaluation of the postoperative aesthetic result is quite subjective and also depends on different factors like time since the operation. A Cochrane analysis from 2010 found a significant advantage for the minilaparoscopic technique as compared to the traditional laparoscopic cholecystectomy, but the follow-up ranged from 1 week to 6 months [7]. One of the analyzed studies did not even register the length of follow-up. An advantage of NC compared to traditional laparoscopic CHE after 1 month was shown in another meta-analysis by Thakur et al. [28]. However, after analyzing only two studies with a follow-up of at least 6 months, the recently published revised version of the Cochrane meta-analysis showed no significant advantage of NC anymore [29]. Still, Saad et al., whose 1-year results were considered, showed a significant advantage after 6 months [30]. Eventually, and despite this ambiguity about improved aesthetics of the NC technique as compared to traditional laparoscopic CHE, we opted for the three-trocar NC instead of the standard laparoscopic CHE as the control group for TVC.
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The question whether TVC is superior to laparoscopic cholecystectomy concerning satisfaction with the aesthetic result has not yet been evaluated in a prospectively randomized design. Comparing 50 TVC patients and 50 patients with traditional laparoscopic cholecystectomy, we already documented higher satisfaction with the aesthetic result following TVC for a long-term follow-up in a cohort analysis [7]. Our current analysis now confirms the comparability of postoperative sexual function as well as the described aesthetic advantages in a prospectively randomized design. However, in contrast to the cohort analysis, we find no significant difference in the overall postoperative result. Since there were no trocar hernias in the NC group of our trial, it was not possible to substantiate the respective theoretical advantage of TVC. One obvious reason is that the cases were far too few and another is that the follow-up of 6 months was much too short.
Conclusions Analysis of the secondary end points of our randomized clinical trial comparing needlescopic three-trocar cholecystectomy with the transvaginal/transumbilical hybrid-NOTES technique for symptomatic cholecystolithiasis showed significantly increased satisfaction with the aesthetic result after 3 and 6 months, while abdominal pain, sexual function, and overall satisfaction with the surgical result were comparable. These results confirm the only existing nonrandomized studies. Thus, possible concerns of patients or their partner in regard to negative consequences following transvaginal access for CHE appear unfounded. Acknowledgments The authors thank PD Dr. S. Sauerland of the Institute for Research in Operative Medicine (IFOM), Cologne, Witten/ Herdecke University, for his assistance with the design of this study, Prof. Dr. Prof. h.c. E. A. M. Neugebauer of the IFOM, Cologne, Witten/ Herdecke University, for his support in the preparation of this manuscript, and Philipp Rossbach, Dallas, Texas, Dipl.-Dolm. Christina Wagner, Witten/Herdecke University, and Prof. Thomas Banchoff, Georgetown University, for proofreading. The authors also thank all participating patients. Conflicts of interest Dirk Rolf Bulian, Jurgen Knuth, Nicola Cerasani, Jonas Lange, Michael Alfred Ströhlein, Axel Sauerwald, and Markus Maria Heiss have no conflicts of interest or financial ties to disclose.
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