Is single-port laparoscopy for benign adnexal disease less painful than conventional laparoscopy? A single-center randomized controlled trial

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1 ORIGINAL ARTICLES: GYNECOLOGY AND MENOPAUSE Is single-port laparoscopy for benign adnexal disease less painful than conventional laparoscopy? A single-center randomized controlled trial Christian Hoyer-Sørensen, M.D., M.Sc., a Ingvild Vistad, M.D., Ph.D., a and Karen Ballard, M.Sc., Ph.D. b a Department of Obstetrics and Gynecology, Sorlandet Hospital Health Authority, Kristiansand, Norway; and b Department of Women's Health, Postgraduate Medical School, University of Surrey, Guildford, United Kingdom Objective: To determine whether laparo-endoscopic single-site surgery (LESS) results in less postoperative pain and a better cosmetic surgical scar compared with conventional laparoscopy. Design: Prospective randomized controlled trial. Setting: A county hospital in Norway. Patient(s): Forty women with benign adnexal disease or a hereditary cancer risk scheduled for laparoscopic adnexal surgery. Intervention(s): LESS or conventional laparoscopy. Main Outcome Measure(s): Postoperative pain 24 hours after surgery. Result(s): There was no difference in pain at 24 hours after surgery, with a mean score of 3.0 (SD 2.1) in the LESS group and 2.5 (SD 1.5) in the conventional laparoscopy group. Significantly more shoulder tip pain was reported by women undergoing LESS compared with those having conventional surgery at 6 and 24 hours after surgery. A high satisfaction with the cosmetic result was reported in both groups, with no significant difference in the Manchester scar scale score. Conclusion(s): Although similar levels of postoperative pain are experienced by women having LESS and conventional laparoscopic surgery, women having LESS report significantly more shoulder tip pain compared to those having conventional laparoscopic surgery. This may relate to a significantly longer operation time in the LESS group. Clinical Trial Registration Number: NCT (Fertil Steril Ò 2012;98: Ó2012 by American Society for Reproductive Medicine.) Key Words: Laparo-endoscopic single-site surgery, single-port laparoscopy, postoperative pain, cosmetic result, adnexal disease Discuss: You can discuss this article with its authors and with other ASRM members at fertstertforum.com/hoyer-sorensenc-single-port-laparoscopy-adnexal-disease/ Use your smartphone to scan this QR code and connect to the discussion forum for this article now.* * Download a free QR code scanner by searching for QR scanner in your smartphone s app store or app marketplace. Laparoscopy was introduced in the 1970s as a less invasive method than laparotomy, with several potential advantages for the patient, such as a reduction in postoperative pain, more rapid mobility after surgery, and a shorter hospital stay. In an effort Received March 12, 2012; revised and accepted June 6, 2012; published online July 04, C.H.-S. has nothing to disclose. I.V. has nothing to disclose. K.B. has nothing to disclose. Reprint requests: Christian Hoyer-Sørensen, M.D., M.Sc., Department of Obstetrics and Gynecology, Sorlandet Hospital HF, Serviceboks 416, 4604 Kristiansand, Norway ( christian.hoyer. sorensen@sshf.no). Fertility and Sterility Vol. 98, No. 4, October /$36.00 Copyright 2012 American Society for Reproductive Medicine, Published by Elsevier Inc. to further reduce the morbidity associated with minimally invasive surgery, a recent innovation has been developed in the form of embryonic naturalorifice transumbilical endoscopic surgery (E-NOTES). With this technique, only one trocar is inserted into the umbilicus, and several instruments, including the optics for visualization, are introduced through this port. This offers a less invasive method than conventional laparoscopy, where up to four ports are used. Additionally, with the E-NOTES technique, the surgical scar is virtually concealed within the umbilicus, an embryonic natural orifice. The first report of an advanced procedure performed through only one incision was published 20 years ago by Pelosi and Pelosi, who described a total hysterectomy with bilateral VOL. 98 NO. 4 / OCTOBER

2 ORIGINAL ARTICLE: GYNECOLOGY AND MENOPAUSE salpingo-oophorectomy using a single puncture technique (1). In 1992 the same authors described four cases of supracervical hysterectomy for benign uterine disease (2). They used a laparoscope with an offset eyepiece and a 5-mm working channel together with standard laparoscopic instruments. Pelosi and Pelosi also reported the first series (n ¼ 25) of single-trocar appendectomies (3), declaring this new approach to be safe, inexpensive, and an effective alternative to the currently used multipuncture method. In the years to follow, reports of other surgical procedures being performed through one incision were published. The first transumbilical cholecystectomy was reported in 1997 (4), and a single-port ovarian cystectomy in an infant was reported in 2001 (5). More recently, adnexal surgery for benign disease has been successfully carried out using single port laparoscopy (6 10), with a randomized control trial showing that women having laparoscopic endoscopic single-site surgery (LESS) experience less pain in the immediate postoperative period (4 hours) compared with women having conventional laparoscopic surgery (11). Those authors also reported greater patient satisfaction with the cosmetic result of the LESS surgery compared with conventional laparoscopic surgery. That is, however, the only randomized trial to compare LESS surgery with conventional laparoscopy for benign adnexal disease. The aim of the present study was to add to that limited evidence by determining whether single-port laparoscopy results in less postoperative pain compared with conventional laparoscopy and whether it leads to greater satisfaction with the cosmetic result. METHODS Following ethical approval (reference no. 2010/2928), from December 2010 to August 2011, women referred to Sorlandet Hospital Kristiansand with presumed benign ovarian disease or a hereditary cancer risk were recruited to the study. Inclusion criteria were women R18 years of age with a presumed benign ovarian disease or a hereditary cancer risk, assessed as having an American Society of Anaesthesiologists score of 1 or 2, and having an ovarian cyst %6 cm. Exclusion criteria were an ovarian cyst >6 cm, presumed endometrioma, previous diagnosis of endometriosis, history of chronic pelvic pain, known severe intra-abdominal adhesions, daily use of analgesics, and inability to give informed consent. At consultation, eligible patients were informed about the study verbally and in writing and invited to participate. Informed consent was gained on the day of admission for surgery. The sample size calculation was based on a 10-point pain scale 24 hours after surgery, using data reported in two studies looking at laparoscopy versus laparotomy for ovarian tumor. Mais et al. (12) reported a mean pain score of 2 (SD 1.34), and Yuen et al. (13) reported a mean pain score of 3.1 (SD 2.5) 24 hours after operative laparoscopy for ovarian tumors. Combining the information from these studies gave an overall mean of 2.5 and SD A difference in pain score of 2 on a 10-point scale would be considered to be clinically significant and would make a single-port laparoscopy approach desirable. The standardized difference is 2/ ¼ 0.876, suggesting that 20 women are needed in each arm to achieve a power of 80%. Randomization was achieved through the use of 40 sealed opaque envelopes in blocks of 6 previously prepared by a statistician. When women were being transferred to the operating theatre, the envelope containing the group allocation was opened by the first author, allowing the operating equipment to be prepared. The primary outcome was postoperative pain measured 24 hours after surgery. Secondary outcome measures were postoperative pain 6 hours after surgery, shoulder tip pain, and satisfaction with cosmetic result, which was selfreported and based on the Manchester scar scale (14). The operating time, blood loss, operative complications, and late complications were registered. Data Analysis The Statistical Package for the Social Sciences (SPSS) version 18.0 was used to analyse the data. A P value of %.05 was considered to be statistically significant. For normally distributed data, a two-tailed Student t test was used to test for group differences. For data not normally distributed, the Mann- Whitney U test was used. Surgical Technique Approximately 1 hour before surgery, all women were given 1.5 g oral paracetamol, 100 mg diclofenac, and 10 mg oyxcodone. Under general anaesthesia, all women had an orogastric tube inserted to decompress the stomach and a Foley catheter inserted into the bladder. In the single-port laparoscopy group, 10 ml 0.5% bupivacaine hydrochloride (Marcain) was injected subcutaneously as local anesthetic before a 2-cm vertical incision (measured with a sterile ruler) was made through the umbilicus. The rectus fascia was sharply incised and a single multiport trocar (Laparo-Endoscopic Single-Site Surgery; Olympus Winter & IBE) was introduced via an introducer device in the peritoneal cavity. This port has an insufflation channel that allows carbon dioxide insufflation with the pressure set at 12 mm Hg. To obtain intraabdominal visualization, a 5-mm 30 telescope (EndoEye; Olympus Winter & IBE) was used. A diagnostic peritoneal lavage was performed. The patient was placed in a Trendelenburg position. A HiQ LS curved hand instrument (Olympus Winter & IBE) was used to provide efficient retraction to optimize surgical exposure. A straight bipolar diathermy and scissors were used to extirpate the cyst or remove the adnexa. After cystectomy or adnexectomy had been performed, the excised tissue was removed through the multichannel port. Larger masses were placed in 10-mm Endo Catch Gold (Covidien) to avoid spillage. If necessary, decompression of pelvic masses was done with a 14-gauge angiocath needle at the umbilical incision after removal of the single-port device. After removal of the tissue, the multichannel access port was opened to evacuate CO 2. The port was removed and the fascia sutured with Polysorb 0 suture. The 974 VOL. 98 NO. 4 / OCTOBER 2012

3 Fertility and Sterility skin was closed using abrupt intracutaneous Polysorb 3-0 sutures. At the start of the study, the surgeons had each performed approximately 15 laparo-endoscopic single-site surgeries. In the conventional laparoscopy group, 5 ml 0.5% bupivacaine hydrochloride (Marcain) was injected as local anaesthetic before a 1-cm incision was made in the umbilicus. Abdominal access was gained by using an open Hasson technique. A suture was placed in the fascia with Polysorb 0. Carbon dioxide was insufflated through this port with a pressure set at 12 mm Hg. Five ml 0.5% bupivacaine hydrochloride (Marcain) was injected at each of the places for three additional ports. Two 5-mm accessory Versaport Bladeless trocars (Covidien) were inserted in the lower right and left quadrants, and a 12-mm Versaport Bladeless trocar was inserted in the midline, 2 cm above the symphysis. Diagnostic peritoneal lavage was performed. Cystectomy or adenexectomy was performed using bipolar diathermy, scissors, and a grasper. The tissue was placed in 10-mm Endo Catch Gold (Covidien) and removed through the incision in the midline above the symphysis, according to the hospital`s standard procedure. If necessary, decompression of pelvic masses was performed with the use of a 14- gauge angiocath needle and the skin incisions extended to a maximum of 2 cm. The fascia in the midline incision above the symphysis was sutured with Polysorb 0 using the Endoclose hook (Covidien). The fascia in the umbilicus was closed with the earlier placed suture, and the skin in the midline incisions was closed with the use of abrupt intracutaneous Polysorb 3 0 sutures. The incisions in the right and left fossa were closed with the use of Steristrips. Two hours after the operations, women were asked if they had any pain and, if so, whether they would like some analgesic relief. If they wished to have analgesia, 1 g paracetamol and 50 mg diclofenac were given. After minutes, women were asked if the analgesia had a satisfactory effect, and if not, they were given 30 mg codeine. Pain scores (abdominal and shoulder tip pain) were registered on a 10-point pain scale at 6 hours and 24 hours after the operation. The use of analgesics during the hospital stay was also registered. Prophylactic antibiotics was not used. All except one woman were discharged from hospital on the first postoperative day. Participants were telephoned by a staff nurse at the Department of Obstetrics and Gynecology 72 hours after surgery and asked about their use of analgesics after discharge. Two months after surgery, women were asked to rate their satisfaction with the cosmetic result on a 5-point scale ranging from extremely unsatisfied to extremely satisfied. The surgical scar was rated with the use of the Manchester scar scale (14) by the first author, who up to that point was unblinded. The Manchester scar scale assesses and rates a scar according to seven parameters: scar color (perfect match or slight, obvious, or gross mismatch to surrounding skin), skin texture (matte or shiny), relationship to surrounding skin (from flush to keloid), texture (from normal to hard), margins (distinct or indistinct), size (<1 cm, 1 5 cm, or >5 cm), and single or multiple. In addition, the Manchester scar scale includes an overall visual analog score (range 0 10) that is added to the individual attribute scores. Scores from the two scales are added together to give an overall score (ranging from 5 to 28) with higher scores representing clinically worse scars. Ethics Approval Approval from the Regional Committee for Medical Research Ethics, Southeast Norway, was granted for the study protocol on December 21, 2010, reference no. 2010/2928. The study was registered with clinicaltrials.gov with the reference no. NCT The Institutional Review Board at Sorlandet Hospital Kristiansand also approved the study. RESULTS Of the 42 women assessed for eligibility, 40 were randomized. Two women declined to participate, because they did not wish to take part in a clinical study. None of the women were lost to follow-up, and they were all analyzed according to their group allocation (Fig. 1). The two treatment groups were similar in age, body mass index, previous abdominal surgery, and indication for the operation (Table 1). There were significantly more premenopausal women in the LESS group than in the conventional laparoscopy group (P¼.02). Postoperative Pain Women in both groups reported similar levels of pain at 6 and 24 hours after surgery (Table 2). The mean pain score in the LESS group was 2.2 (SD 2.1) and in the conventional laparoscopy group was 1.9 (SD 1.7) 6 hours after surgery (P¼.62). After 24 hours, the mean pain score was 3.0 (SD 2.1) in the LESS group and 2.5 (SD 1.5) in the conventional laparoscopy group (P¼.35). Women having LESS surgery reported a higher level of shoulder tip pain than those having conventional laparoscopy. Six hours after surgery, the median shoulder tip pain score in the laparo-endoscopic single-site surgery group was 2.4 (interquartile range [IQR] 5) and 0.6 (IQR 0) in the conventional laparoscopy group (U ¼ 119.5; P¼.01). After 24 hours, the median scores were 3.1 (IQR 4) in the LESS group and 1.4 (IQR 2) in the conventional laparoscopy group (U ¼ 123; P¼.03). Analgesia use at 24 hours and 72 hours after surgery was similar in both groups, with women having LESS surgery using a mean of 1.9 units paracetamol, 1.6 units diclofenac, and 1.4 units of codeine, compared with women having conventional laparoscopy using 1.8 units, 1.6 units, and 1.6 units, respectively (Table 3). Cosmetic Result The majority of women having surgery reported being extremely satisfied with the cosmetic result 2 months after surgery. Seventeen women having LESS reported being extremely satisfied and three reported being very satisfied. In the conventional laparoscopy group, 15 women reported being extremely satisfied with the cosmetic result, four were very satisfied, and one woman was satisfied. The mean Manchester scar scores were similar in both groups; women having LESS surgery were rated as having VOL. 98 NO. 4 / OCTOBER

4 ORIGINAL ARTICLE: GYNECOLOGY AND MENOPAUSE FIGURE 1 Consort flow diagram of the patients. a mean score of 10.4 (SD 2.6) and those having conventional laparoscopy were scored as 11.1 (SD 2.6; P¼.46). One woman in each group did not have their scars scored and were therefore excluded from the analyses. TABLE 1 Baseline characteristics. Conventional laparoscopy (n [ 20) P value LESS Characteristic (n [ 20) Age (y), mean (SD) 55.1 (16.2) 58.7 (10.8).41 Body mass index (kg/m 2 ), 25.1 (5.5) 25.4 (4.8).83 mean (SD) Premenopausal, n (%) 11 (55) 4 (20).02 Previous abdominal 13 (65) 10 (50).35 surgery, n (%) Indications for operation, n (%) Ovarian cyst 17 (85) 18 (90).81 Hereditary cancer risk 3 (15) 2 (10) NA Note: LESS ¼ laparo-endoscopic single-site surgery; NA ¼ not applicable. Operative Outcomes The median operation time was 42 minutes (IQR 14) in the LESS group, compared with 31 minutes (IQR 7) in the conventional laparoscopy group (P¼.03). An intra-abdominal lavage was performed in 85% of women having LESS surgery and in 90% having conventional laparoscopy. None of the women experienced blood loss of >50 ml. Seventeen women in the LESS group and 18 in the conventional laparoscopy group had a bilateral salpingooophorectomy, unilateral salpingo-oophorectomy, cystectomy, or resection of an ovary. A salpingo-oophorectomy was performed on most women, i.e., women with hereditary cancer risk, postmenopausal women, as well as two premenopausal women (who were >50 years old). In the LESS group, pelvic adhesions were found in 3 of 20 patients and none required adhesiolysis. In the conventional laparoscopy group, 5 of 20 patients had pelvic adhesions, and laparoscopic adhesiolysis was required in 4. In the LESS group a diagnostic laparoscopy was performed in two women. The first had severe adhesions in the pelvis, hiding the ovaries. Owing to a low risk of malignancy index, no further surgery was performed. In the second, the ovaries were adherent to the posterior wall of the uterus. The pouch of Douglas was obliterated, and there were adhesions between the sigmoid, ovaries, and uterus. There were no signs of carcinomatosis. The operation was ended and a magnetic resonance scan was performed, which indicated old endometriotic lesions. In the conventional laparoscopy group, one woman had a salpingectomy owing to hydrosalpinx, and in another 976 VOL. 98 NO. 4 / OCTOBER 2012

5 Fertility and Sterility TABLE 2 Self-reported pain (on a 10-point scale) in women having laparoendoscopic single-site surgery (LESS) and conventional laparoscopy. woman division of adhesions was performed. At surgery, an umbilical trocar was first placed. Thereafter an additional trocar was placed in the upper right quadrant of the abdomen, where there were no adhesions. Division of adhesions was performed to gain access to the pelvis. It turned out that there were no ovarian cysts, but pseudocysts, because of adhesions that had been perceived to be cysts on transvaginal ultrasound scanning. These pseudocysts were fenestrated and the operation ended. The removed tissue from all women was sent for histopathologic examination. In the LESS group, three women had their adnexa removed owing to hereditary cancer risk and two women had a diagnostic laparoscopy performed. Of the remaining 15 women, the histopathologic diagnosis showed eight cases of serous cystadenoma, four cases of inclusion cysts and three cases of mature cystic teratomas. In the conventional laparoscopy group, two women had their adnexa removed owing to hereditary cancer risk and one woman had a diagnostic laparoscopy. Of the remaining 17 women, the histopathologic diagnosis showed 9 cases of serous cystadenoma, three cases of inclusion cyst, 2 cases of endometrioma, and 1 case each of Brenner tumor, hydrosalpinx, and mucinous cystadenoma. The examinations of the abdominal lavage performed showed a benign cytology. The median TABLE 3 LESS (n [ 20) Use of analgesics (units, mean). LESS (n [ 20) Conventional laparoscopy (n [ 20) P value Postoperative pain (mean) After 6 h 2.2 (SD 2.1) 1.9 (SD 1.7).62 a After 24 h 3.0 (SD 2.1) 2.5 (SD 1.5).35 a Shoulder tip pain (median) After 6 h 2.4 (IQR 5) 0.6 (IQR 0).01 b After 24 h 3.1 (IQR 4) 1.4 (IQR 2).03 b a Student t test. Mann-Whitney U test. Conventional laparoscopy (n [ 20) P value* 24 h after surgery Paracetamol 1.9 (SD 0.8) 1.8 (SD 1.2).76 Diclofenac 1.6 (SD 1.2) 1.6 (SD 1.1) 1.0 Codeine 1.4 (SD 2.2) 1.6 (SD 1.9) h after surgery Paracetamol 1.5 (SD 1.4) 1.7 (SD 1.4).58 Diclofenac 1.3 (SD 1.5) 1.4 (SD 1.9).85 Codeine 0 0 NA Note: Paracetamol: 1 unit ¼ 1,000 mg; diclofenac: 1 unit ¼ 50 mg; codeine: 1 unit ¼ 30 mg. * Student t test. adnexal mass size was 45 mm (IQR 22) in the LESS group and 44 mm (IQR 21) in the conventional laparoscopy group (P¼.68). In the LESS group, one woman had bilateral disease, whereas three women had bilateral disease in the conventional laparoscopy group. There were no intraoperative complications. After surgery, one woman in the conventional laparoscopy group experienced urinary retention. She was catheterized several times, and after 3 days she was discharged without any bladder problems. In the LESS group, two women had a superficial wound infection, one of which was treated with antibiotics. At 2 months after surgery, both wounds had completely healed. DISCUSSION This is the second randomized controlled trial comparing pain scores after LESS and conventional laparoscopy for benign adnexal disease. In contrast to the earlier trial (11), where women having LESS surgery were found to report a lower level of pain 4 hours after surgery than those having conventional laparoscopy, we found no significant group difference in postoperative pain. In the earlier trial, standardized time intervals from 20 minutes to 8 hours were used when evaluating the postoperative pain score. We chose to evaluate the experienced pain up to 24 hours after surgery, because we think that the experienced pain in the first hours after surgery could be influenced by the general analgesia given. We also found that women in both groups used similar amounts of postoperative analgesia; again, this is at odds with the findings of Fagotti et al., who reported higher use of postoperative analgesia in women having conventional laparoscopy. Moreover, we found that women having LESS surgery reported significantly greater levels of postoperative shoulder tip pain, a finding not reported in the earlier trial (11). These apparently contradictory results in postoperative pain could be explained by the differences in operative time that we experienced, LESS surgery taking a median operative time of 42 minutes compared with a median operative time of 31 minutes for conventional laparoscopy. This is in contrast to the operative times reported in the earlier trial by Fagotti et al. (11), which were similar in both groups (52 and 56 minutes, respectively). It is likely that that the longer operating time in the LESS group is partly a result of the technique used with this approach. It is more time consuming to use the curved grasper to bring the tissue to the desired position, and the multiport trocar leaves only one working channel after the laparoscope and the grasping forceps are installed. When both bipolar diathermy and a laparoscopic scissors are required, they have to be used separately. If modifications were made to the multiport trocar, it is possible that the surgical procedure could be performed more rapidly, possibly producing better outcomes for the patients. Other studies have also reported longer operative times associated with LESS (7, 9), which may be due to inexperience with the surgical equipment or a need to develop more complex operative skills. In our study, both surgeons had undertaken more than 15 procedures using LESS, suggesting that a greater number of procedures need to be done before VOL. 98 NO. 4 / OCTOBER

6 ORIGINAL ARTICLE: GYNECOLOGY AND MENOPAUSE eliminating the potential for longer surgery times and possibly increased shoulder tip pain. It is possible, therefore, that the greater amount of shoulder tip pain experienced by women having LESS surgery influenced their overall perception of pain, resulting in higher reported surgery pain scores. Possible reasons for shoulder tip pain after laparoscopy include retention of operative gases (15), a high level of operative intra-abdominal pressure (16), and a slow absorption rate of smoke generated through diathermy. Although not objectively measured, because both surgical approaches in the present study used similar amounts of diathermy and had similar levels of operative intraabdominal pressure, the increased shoulder tip pain is possibly due to either the increased operative time or perhaps a reduced ability to expel the operative gases through a single port. In addition to the variance between our pain results and those reported by Fagotti et al., we also did not observe any differences in satisfaction with the cosmetic result from the surgery, although the study was not powered for cosmesis. Unlike Fagotti et al., who reported greater patient and doctor satisfaction with cosmesis after LESS surgery compared with conventional laparoscopy, we found that both groups had equally high satisfaction with the cosmetic result. We suggest that the multiple incisions used at conventional laparoscopy are judged to be equal to the slightly longer incision used at LESS. The strengths of the present randomized trial were the successful recruitment of an adequate sample size, the completeness of the follow-up, the equal treatment of both groups, and the procedures being performed by the same two surgeons. The limitations of the study were the lack of surgeon blinding and the ability for participants to see which surgical approach was used. Furthermore, because our results revealed a longer operating time in the LESS group, it could be argued that the surgeons should have performed at least LESS procedures before the study start to be classified as competent. When starting to undertake the LESS approach, both surgeons had initially experienced longer operating times, largely owing to the need to get used to manipulating the instruments. They therefore felt that they had reached the end of their learning curve once they felt more comfortable using the instruments and had a shorter operating time. The authors reached this state after 15 procedures, similarly to a retrospective study that postulated that surgical proficiency is possible after cases (17). Before undertaking the trial, however, the surgery was not timed and an objective measurement of a plateaued learning curve was therefore not achieved. The significantly greater number of premenopausal women in the LESS group is a potential weakness of the study, because this created a difference in surgical findings, with three women in the LESS group having dermoid cyst removal, whereas none of the women in the conventional laparoscopy group had dermoid cysts. Had these cysts been ruptured in the process of their removal, we would expect these women to experience more pain. However, we were able to remove all of the dermoid cysts without rupturing them, and therefore it is likely that they did not cause greater levels of pain. Although the sample size was not large enough to produce completely similar groups, it was large enough to detect potential differences in our primary outcome measure: postoperative pain 24 hours after adnexal laparoscopic surgery. This study suggests that laparo-endoscopic single-site surgery is an additional technique that can be used to treat adnexal disease, resulting in low pain scores and high satisfaction with the cosmetic result, although possibly in less experienced hands it is associated with more shoulder tip pain than conventional laparoscopy. For some women, the cosmetic result after surgery may be an important outcome. The satisfaction with the cosmetic result is very high in both groups. The advocated advantage of LESS of concealing the scar within the umbilicus and performing a so-called invisible surgery, did not seem to result in higher satisfaction among the patients. LESS still has some technical problems to overcome. The introduction of curved instruments has helped to overcome the problem of triangulation. Despite this, it could be argued that the available equipment to date does not function optimally and that further development is needed. The single multiport trocar sometimes tends to rotate during the procedure, resulting in a less optimal placement of the hand instruments in relation to each other. To reduce the learning curve, it would be wise to introduce standardized step-by-step procedures. These should include the placement (rotation) of the multiport trocar and where to introduce each specific hand instrument and the optics. The medical industry should be the initiator of this process in close collaboration with clinicians. CONCLUSION Women having LESS for adnexal disease experience levels of postoperative pain similar to women having conventional laparoscopy. However, the duration of surgery time was longer in LESS, which may have led to our findings of greater shoulder tip pain being reported by women having LESS surgery. Satisfaction with the cosmetic result of both LESS and conventional surgery is extremely high. LESS is in its infancy. The present study failed to demonstrate its superiority compared with conventional laparoscopy, but it did suggest that it is a reasonable alternative and, similarly to conventional laparoscopy, it is associated with low postoperative pain and a high satisfaction with the cosmetic result. New surgical equipment should not be implemented uncritically. Further development of the equipment used for LESS is awaited. This might reduce the operating time, which in turn may reduce the shoulder tip pain. Acknowledgments: The authors thank Dr. Sigurd Hortemo, who performed the surgeries together with the first author, and Sigurd Johnsen at the Postgraduate Medical School, University of Surrey, for statistical support. REFERENCES 1. Pelosi MA, Pelosi MA 3rd. Laparoscopic hysterectomy with bilateral salpingo-oophorectomy using a single umbilical puncture. N J Med 1991; 88: Pelosi MA, Pelosi MA 3rd. Laparoscopic supracervical hysterectomy using a single-umbilical puncture (minilaparoscopy). J Reprod Med 1992;37: VOL. 98 NO. 4 / OCTOBER 2012

7 Fertility and Sterility 3. Pelosi MA, Pelosi MA 3rd. Laparoscopic appendectomy using a single umbilical puncture (minilaparoscopy). J Reprod Med 1992;37: Navarra G, Pozza E, Occhionorelli S, Carcoforo P, Donini I. One-wound laparoscopic cholecystectomy. Br J Surg 1997;84: Kosumi T, Kutoba A, Usui N, Yamauchi K, Yamasaki M, Oyanagi H. Laparoscopic ovarian cystectomy using single umbilical puncture method. Surg Laparosc Endosc Percutan Tech 2001;11: Fagotti A, Fanfani F, Rossitto C, Marocco F, Gallotta V, Romano F, et al. Laparoendoscopic single-site surgery for the treatment of benign adnexal disease: a prospective trial. Diagn Ther Endosc 2010;2010: Kim TJ, Lee YY, Kim MJ, Kim CJ, Kang H, Choi CH, et al. Single port access laparoscopic adnexal surgery. Journal Minim Invasive Gynecol 2009;16: Lee YY, Kim TJ, Kim CJ, Park HS, Choi CH, Lee JW, et al. Single port access laparoscopic adnexal surgery versus conventional laparoscopic adnexal surgey: a comparison of peri-operative outcomes. Eur J Obstet Gynecol Reprod Biol 2010;151: Escobar PF, Bedaiwy MA, Fader AN, Falcone T. Laparoendoscopic single-site (LESS) surgery in patients with benign adnexal disease. Fertil Steril 2010;93: 2074.e Mereu L, Angioni S, Melis GB, Mencaglia L. Single access laparoscopy for adnexal pathologies using a novel reusable port and curved instruments. Int J Gynecol Obstet 2010;109: Fagotti A, Bottoni C, Vizzielli G, Alletti SG, Scambia G, Marana E, et al. Postoperative pain after conventional laparoscopy and laparoendoscopic single site surgery (LESS) for benign adnexal disease: a randomized trial. Fertil Steril 2011;96: Mais V, Ajossa S, Piras B, Marongiu D, Guerriero S, Melis GB. Treatment of non endometriotic benign adnexal cysts: a randomised comparison of laparoscopy and laparotomy. Obstet Gynecol 1995;86: Yuen PM, Yu KM, Yip SK, Lau WC, Rogers MS, Chang A. A randomized prospective study of laparoscopy and laparotomy in the management of benign ovarian masses. Am J Obstet Gynecol 1997;177: Beausang E, Floyd H, Dunn K, Orton CI, Ferguson MW. A new quantitative scale for clinical scar assessment. Plast Reconst Surg 1998;102: Atak I, Ozbagriacik M, Akinci OF, Bildik N, Subasi IE, Ozdemir M, et al. Active gas aspiration to reduce pain after laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech 2011;21: Gurusamy KS, Samraj K, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev 2009;15:CD Escobar PF, Starks DC, Fader DN, Barber M, Rojas-Espalliat L. Single-port risk-reducing salpingo-oophorectomy with and without hysterectomy: surgical outcomes and learning curve analysis. Gynecol Oncol 2010; 119:43 7. VOL. 98 NO. 4 / OCTOBER