Lincolnshire Knowledge and Resource Service

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1 Lincolnshire Knowledge and Resource Service This search summary contains the results of a literature search undertaken by the Lincolnshire Knowledge and Resource Service librarians in; October 2013 All of the literature searches we complete are tailored to the specific needs of the individual requester. If you would like this search re-run with a different focus, or updated to accommodate papers published since the search was completed, please let us know. We hope that you find the information useful. If you would like the full text of any of the abstracts listed, please let us know. Alison Price Janet Badcock Alison.price@lincolnshire.gov.uk janet.badcock@lincolnshire.gov.uk Librarians, Lincolnshire Knowledge and Resource Service Lexicon House Stephenson Road North Hykeham Lincoln LN6 3QU

2 Lincolnshire Knowledge and Resource Service Please find below the results of your literature search request. If you would like the full text of any of the abstracts included, or would like a further search completed on this topic, please let us know. Google can bring you back 100,000 answers, a librarian can bring you back the right one. Neil Gaiman Literature Search Results Search completion date: 04/10/13 Search completed by: Jan Badcock Enquiry Details Patient: Males Undergoing Vasectomy Intervention: Intervention Outcome: Best method for good outcome. Publication type limit: Randomised Controlled Trial, clinical trial 1

3 Disclaimer Every effort has been made to ensure that this information is accurate, up-to-date, and complete. However it is possible that it is not representative of the whole body of evidence available. No responsibility can be accepted for any action taken on the basis of this information. It is the responsibility of the requester to determine the accuracy, validity and interpretation of the search results. All links from this resource are provided for information only. A link does not imply endorsement of that site and the Lincolnshire Knowledge and Resource Service does not accept responsibility for the information displayed there, or for the wording, content and accuracy of the information supplied which has been extracted in good faith from reputable sources. Opening Internet Links The links to internet sites in this document are live and can be opened by holding down the CTRL key on your keyboard while clicking on the web address with your mouse Papers Links are given to full text resources where available. For some of the papers, you will need a free NHS Athens Account. If you do not have an account you can register by following the steps at: You can then access the papers by simply entering your username and password. If you do not have easy access to the internet to gain access, please let us know and we can download the papers for you. Guidance on Searching within Online Documents Links are provided to the full text of each of these documents. Relevant extracts have been copied and pasted into these Search Results. Rather than browse through often lengthy documents, you can search for specific words and phrases as follows: Portable Document Format / pdf. / Adobe Click on the Search button (illustrated with binoculars). This will open up a search window. Type in the term you need to find and links to all of the references to that term within the document will be displayed in the window. You can jump to each reference by clicking it. You can search for more terms by pressing search again. Word documents Select Edit from the menu, the Find and type in your term in the search box which is presented. The search function will locate the first use of the term in the document. By pressing next you will jump to further references. 2

4 Guidelines Male and Female Sterilisation Evidence-based Clinical Guideline Number 4 January 2004 Royal College of Obstetricians and Gynaecologists This is an excerpt from the 10 paged Vasectomy Chapter on male sterilisation: "Chapter 7 Vasectomy 7.1 Methods of vasectomy Recommendation 37 Except when technical considerations dictate otherwise, a no-scalpel approach should be used to identify the vas, as this results in a lower rate of early complications. Recommendation 38 Division of the vas on its own is not an acceptable technique because of its failure rate. It should be accompanied by fascial interposition or diathermy. Recommendation 39 Clips should not be used for occluding the vas, as failure rates are unacceptably high. Vasectomy is performed in two separate steps. First, the vas deferens has to be exposed out of the scrotum and then the vas must be occluded or interrupted. Conventionally, one or two incisions are made with a scalpel and the fascial layers divided until the vas is exposed. A newer technique is the no-scalpel vasectomy developed by Li Shun Quiang et al.194 This method was developed to increase the acceptability of vasectomy by eliminating the fear of the incision. The technique employs two unique instruments. After anaesthesia is injected, a specially designed fixation clamp encircles and firmly secures the vas without penetrating the skin. The second instrument, a sharp-tipped dissecting forceps, is then used to puncture the skin and vas sheath and stretch a small opening in the scrotum. The vas is lifted and occluded, as with other vasectomy techniques. The same puncture site can be used for the opposite vas or a separate puncture can be made. Two randomised controlled trials have evaluated these two methods of approach to the vas.195,196 The larger trial involved 1429 men and found that the Li method took less time and significantly reduced short-term complications of bleeding, haematoma formation, infection and pain. Long-term complications were similar in both groups, as were early failure rates.195 The smaller trial only involved 99 men and, as it found no significant differences between complication rates, may have been underpowered." Vasectomy: AUA guideline. Sharlip ID, et al.. Vasectomy: AUA guideline. Linthicum (MD): American Urological Association Education and Research, Inc. (AUA); 2012 May. 57 p. This is an American guideline. Request from LKRS 3

5 Evidence Systematic Reviews / Summaries Clinical knowledge Summaries This is a site maintained by NICE that provides the recommended for vasectomy Contraception sterilization Last revised in June 2012 Vasectomy occlusion techniques for male sterilization DUETS Database of Uncertainties and Treatment Effects Group 14 Mar 2012 Why is there uncertainty? Reliable up-to-date systematic reviews have revealed important continuing uncertainties about treatment effects Which types of treatments? Surgery Which outcomes? Background Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide, including vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), as well as vasectomy with vas irrigation or with fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the evidence from randomized controlled trials (RCTs). Objectives The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization.. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. Peto odds ratios (OR) with 95% confidence intervals (CI) were used for dichotomous outcomes, such as azoospermia. The mean difference (MD) was used for the continuous variable of operating time. Results Six studies met the inclusion criteria. One trial compared vas occlusion with clips versus a conventional vasectomy technique. No difference was found in failure to reach azoospermia (no sperm detected). Three trials examined vasectomy with vas irrigation. Two studies looked at irrigation with water versus no irrigation, while one examined irrigation with water versus the spermicide euflavine. None found a difference between the groups for time to azoospermia. However, one trial reported that the median number of ejaculations to azoospermia was lower in the euflavine group compared to the water irrigation group. One high-quality trial compared vasectomy with fascial interposition versus vasectomy without fascial interposition. The fascial interposition group was less likely to have vasectomy failure. Fascial interposition had more surgical difficulties, but the groups were similar in side effects. Lastly, one trial found that an intra-vas was less likely to produce azoospermia than was no-scalpel vasectomy. More men were satisfied with the intra-vas Devices, however. Authors' conclusions For vas occlusion with clips or vasectomy with vas irrigation, no conclusions can be made as those studies were of low quality and underpowered. Fascial interposition reduced vasectomy failure. An intra-vas Devices was less effective in reducing sperm count than was no-scalpel vasectomy. RCTs examining other vasectomy techniques were not available. More and better quality research is needed to examine vasectomy techniques. 4

6 Scalpel versus no-scalpel incision for vasectomy DUETS Database of Uncertainties and Treatment Effects 14 Mar 2012 Record type Uncertainties identified in research recommendations Source Publication date: 14 Mar 2012 Cochrane Fertility Regulation Group Why is there uncertainty? Reliable up-to-date systematic reviews have revealed important continuing uncertainties about treatment effects Which outcomes? Success of vasectomy; contraceptive efficacy; adverse surgical events; bleeding; bruising; hematoma; infection; pain; length of operation; acceptability; discontinuation; and resumption of sexual activity Record ID: Publication date: 14 Mar 2012 Intervention Review Scalpel versus no-scalpel incision for vasectomy Lynley A Cook, et al : Cochrane Fertility Regulation Group Published Online: 8 JUL 2009 Assessed as up-to-date: 17 OCT 2011 Objectives The objective of this review was to compare the effectiveness, safety, and acceptability of the incisional versus no-scalpel approach to the vas. Main results Two randomized controlled trials evaluated the no-scalpel technique and differed in their findings. The larger trial demonstrated less perioperative bleeding (OR 0.49; 95% CI 0.27 to 0.89) and pain during surgery (OR 0.75; 95% CI 0.61 to 0.93), scrotal pain (OR 0.63; 95% 0.50 to 0.80), and incisional infection (OR 0.21; 95% CI 0.06 to 0.78) during follow up than the standard incisional group. Both studies found less hematoma with the no-scalpel technique (OR 0.23; 95% CI 0.15 to 0.36). Operations using the no-scalpel approach were faster and had a quicker resumption of sexual activity. The smaller study did not find these differences; however, the study could have failed to detect differences due to a small sample size as well as a high loss to follow up. Neither trial found differences in vasectomy effectiveness between the two approaches to the vas. Authors' conclusions The no-scalpel approach to the vas resulted in less bleeding, hematoma, infection, and pain as well as a shorter operation time than the traditional incision technique. No difference in effectiveness was found between the two approaches. 5

7 Intervention Review Vasectomy occlusion techniques for male sterilization Lynley A Cook et al. Cochrane Fertility Regulation Group Published Online: 8 JUL 2009 Assessed as up-to-date: 17 OCT 2011 Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide, including vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), as well as vasectomy with vas irrigation or with fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the evidence from randomized controlled trials (RCTs). Objectives The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization. Main results Six studies met the inclusion criteria. One trial compared vas occlusion with clips versus a conventional vasectomy technique. No difference was found in failure to reach azoospermia (no sperm detected). Three trials examined vasectomy with vas irrigation. Two studies looked at irrigation with water versus no irrigation, while one examined irrigation with water versus the spermicide euflavine. None found a difference between the groups for time to azoospermia. However, one trial reported that the median number of ejaculations to azoospermia was lower in the euflavine group compared to the water irrigation group. One high-quality trial compared vasectomy with fascial interposition versus vasectomy without fascial interposition. The fascial interposition group was less likely to have vasectomy failure. Fascial interposition had more surgical difficulties, but the groups were similar in side effects. Lastly, one trial found that an intra-vas was less likely to produce azoospermia than was no-scalpel vasectomy. More men were satisfied with the intra-vas device, however. Authors' conclusions For vas occlusion with clips or vasectomy with vas irrigation, no conclusions can be made as those studies were of low quality and underpowered. Fascial interposition reduced vasectomy failure. An intra-vas device was less effective in reducing sperm count than was no-scalpel vasectomy. RCTs examining other vasectomy techniques were not available. More and better quality research is needed to examine vasectomy techniques. Effectiveness of vasectomy techniques. Sokal DC, Labrecque M. Urol Clin North Am Aug;36(3): The effectiveness of various vasectomy techniques is reviewed, with a focus on methods used for vas occlusion. Spontaneous recanalization of the vas is more common than generally recognized and is often transient. Simple ligation and excision has an unacceptably high risk for failure. Techniques that include cautery seem to have a lower risk for failure than techniques that do not include cautery. There is insufficient evidence to recommend a particular standardized cautery technique, but adding fascial interposition to cautery seems to be associated with the lowest risk for failure. 6

8 Review Techniques of vasectomy. Art KS, Nangia AK. Urol Clin North Am Aug;36(3): Vasectomy remains a safe and effective method of contraception for men. Many variations in surgical technique currently are used by surgeons in the United States, each with its own benefits and drawbacks. Regardless of the surgical method used, the most important factor for successful vasectomy remains the experience and skill of the surgeon. The amount of evidence-based literature on the rationale for the different techniques for vasectomy remains limited. Careful study and innovation of vasectomy techniques will ensure that the most commonly performed urologic surgical procedure remain an excellent form of contraception in the future. Effectiveness of vasectomy techniques. Sokal DC, Labrecque M. review Urol Clin North Am Aug;36(3): The effectiveness of various vasectomy techniques is reviewed, with a focus on methods used for vas occlusion. Spontaneous recanalization of the vas is more common than generally recognized and is often transient. Simple ligation and excision has an unacceptably high risk for failure. Techniques that include cautery seem to have a lower risk for failure than techniques that do not include cautery. There is insufficient evidence to recommend a particular standardized cautery technique, but adding fascial interposition to cautery seems to be associated with the lowest risk for failure. Vasectomy surgical techniques: a systematic review Labrecque M, Dufresne C, Barone M A, St-Hilaire K BMC Medicine 2004, 2:21 CRD summary This review assessed the occlusive and contraceptive effectiveness of surgical techniques to isolate or occlude the vas during vasectomy. The authors concluded that no-scalpel vasectomy is the safest surgical approach; adding fascial interposition increases effectiveness as does combining fascial interposition with cautery. Given the poor study quality and limited study details and analyses, the conclusions should be interpreted with caution. Authors' objectives To assess if any surgical techniques to isolate or occlude the vas are associated with better outcomes with regard to occlusive and contraceptive effectiveness and complications. In particular: Is no-scalpel vasectomy associated with a lower risk of surgical complications compared with the standard incisional technique? Is any single occlusion method associated with a higher occlusive and/or contraceptive effectiveness compared with other occlusion methods? Is any single occlusion method associated with a lower risk of complications compared with other occlusion methods? Results of the review Thirty-one studies (n>9,977,963, exact number unclear due to multiple comparisons and missing information) were included. Four were randomised controlled trials (n=2,136) and four were non-randomised trials or quasi-randomised controlled trials (n>2,878, exact number unclear due to multiple comparisons); the other studies (n>9,972,949, exact number unclear due to multiple comparisons and missing information) were case series with historical or concurrent controls, cohort studies, before-and-after studies, or of unspecified design. Overall, the methodological quality of the studies was low. Agreement between the two reviewers was high (kappa 0.80, 95% confidence interval: 0.67, 0.83). 7

9 Five studies showed in at least one dataset that fascial interposition increases the occlusive effectiveness of ligation and excision; only one of these reported a statistically significant difference. Eleven studies investigated cautery of the vas lumen; seven showed better results for cautery versus ligation in at least one dataset. Of the nine studies evaluating vas isolation, five reported fewer total complications, five reported fewer bleeding or haematoma, and six reported fewer infections with the noscalpel vasectomy approach compared with incisional techniques. However, not all of the comparisons were statistically significant. Numerous other results were reported in the review. Authors' conclusions The existing evidence supports no-scalpel vasectomy as the safest surgical approach to isolate the vas when performing vasectomy. Adding fascial interposition increases effectiveness beyond ligation and excision alone; combining fascial interposition with cautery further improves effectiveness. Research article Effectiveness of vasectomy using cautery Mark A Barone, et al.bmc Urology 2004, 4:10 Background Little evidence supports the use of any one vas occlusion method. Data from a number of studies now suggest that there are differences in effectiveness among different occlusion methods. The main objectives of this study were to estimate the effectiveness of vasectomy by cautery and to describe the trends in sperm counts after cautery vasectomy. Other objectives were to estimate time and number of ejaculations to success and to determine the predictive value of success at 12 weeks for final status at 24 weeks. Methods A prospective, non-comparative observational study was conducted between November 2001 and June 2002 at 4 centers in Brazil, Canada, the UK, and the US. Four hundred men who chose vasectomy were enrolled and followed for 6 months. Sites used their usual cautery vasectomy technique. Earlier and more frequent than normal semen analyses (2, 5, 8, 12, 16, 20, and 24 weeks after vasectomy) were performed. Planned outcomes included effectiveness (early failure based on semen analysis), trends in sperm counts, time and number of ejaculations to success, predictive value of success at 12 weeks for the outcome at 24 weeks, and safety evaluation. Results A total of 364 (91%) participants completed follow-up. The overall failure rate based on semen analysis was 0.8% (95% confidence interval 0.2, 2.3). By 12 weeks 96.4% of participants showed azoospermia or severe oligozoospermia (< 100,000 sperm/ml). The predictive value of a single severely oligozoospermia sample at 12 weeks for vasectomy success at the end of the study was 99.7%. One serious unrelated adverse event and no pregnancies were reported. Conclusion Cautery is a very effective method for occluding the vas. Failure based on semen analysis is rare. In settings where semen analysis is not practical, using 12 weeks as a guideline for when men can rely on their vasectomy should lessen the risk of failure compared to using a guideline of 20 ejaculations after vasectomy. 8

10 A comparison of vas occlusion techniques: cautery more effective than ligation and excision with fascial interposition David Sokal, et al BMC Urology 2004, 4:12 Background Vasectomy techniques have been the subject of relatively few rigorous studies. The objective of this analysis was to compare the effectiveness of two techniques for vas occlusion: intraluminal cautery versus ligation and excision with fascial interposition. More specifically, we aimed to compare early failure rates, sperm concentrations, and time to success between the two techniques. Methods We compared semen analysis data from men following vasectomy using two occlusion techniques. Data on intraluminal cautery came from a prospective observational study conducted at four sites. Data on ligation and excision with fascial interposition came from a multicenter randomized controlled trial that evaluated the efficacy of ligation and excision with versus without fascial interposition. The surgical techniques used in the fascial interposition study were standardized. The surgeons in the cautery study used their customary techniques, which varied among sites in terms of type of cautery, use of fascial interposition, excision of a short segment of the vas, and use of an open-ended technique. Men in both studies had semen analyses two weeks after vasectomy and then approximately every four weeks. The two outcome measures for the analyses presented here are (a) time to success, defined as severe oligozoospermia, or <100,000 sperm/ml in two consecutive semen analyses; and (b) early vasectomy failure, defined as >10 million sperm/ml at week 12 or later. Results Vasectomy with cautery was associated with a significantly more rapid progression to severe oligozoospermia and with significantly fewer early failures (1% versus 5%). Conclusion The use of cautery improves vasectomy outcomes. Limitations of this comparison include (a) the variety of surgical techniques in the cautery study and differences in methods of fascial interposition between the two studies, (b) the uncertain correlation between sperm concentrations after vasectomy and the risk of pregnancy, and (c) the use of historical controls and different study sites. Research Scrotal haematoma: The most common complication of no-scalpel vasectomy Kathmandu University Medical Journal, 2007, vol./is. 5/18( ), ; (2007) Pant P.R.; Sharma J.; Subba S. Objective: to study the complications of no scalpel vasectomy such as scrotal haematoma,infection, scrotal sinus, and failure, recanalization, and sperm granuloma. Materials and methods: A retrospective, descriptive study carried out in Dept. of Obs/ Gyn, Tribhuvan University Teaching Hospital Kathmandu Nepal. Result: Among 926 no scalpel vasectomy clients 5(0.53%) had scrotal haematoma, 4(0.43%) with had infection, 3(0.32%) had scrotal sinus; there were 2 cases each vasectomy failure who could not achieve azospermia and 2 with recanalization while there was only one case of sperm granuloma. Conclusion: the most common complication of no-scalpel vasectomy was scrotal haematoma and other complications are wound infection, scrotal sinus, vasectomy failure and sperm granuloma. Publication Type: Journal: Article Source: EMBASE 9

11 Comparison of Marie Stopes scalpel and electrocautery no-scalpel vasectomy techniques Journal of Family Planning and Reproductive Health Care, April 2003, vol./is. 29/2(32-34), (April 2003) Black T.; Francome C. Evidence Services library.nhs.uk Abstract: Objective. To compare the intra-operative experience and postoperative sequelae between the standard Marie Stopes scalpel vasectomy procedure and electrocautery non-scalpel vasectomy (ENSV) techniques. Design. Randomised prospective comparative study. Setting. Marie Stopes vasectomy centres in the UK. Participants. A total of 325 men undergoing vasectomy between January and June Intervention. Random allocation to the two study arms plus questionnaires at 4 and 14 weeks postoperatively. Main outcome measures. Ease and speed of the procedure; pain levels during and after the procedure; early postoperative complications and time taken to return to work and sexual activity. Results. The ENSV technique was marginally quicker to perform. Pain levels intra-operatively were comparable. Response rates to the questionnaire were 84.6% and 37% at 4 and 14 weeks, respectively. The ENSV group experienced less pain and bleeding from the wound postoperatively and were quicker to heal. For men who experienced postoperative problems, the time taken to return to work was marginally better in the ENSV group. The time taken to return to sexual activity was marginally faster in the ENSV group. Conclusion. The ENSV procedure appears to be suitable for mass application in locations where electricity is available. Publication Type: Journal: Article Source: EMBASE An implantable ligation device that achieves male sterilization without cutting the vas deferens Urology, April 2006, vol./is. 67/4( ), ; (April 2006) Kirby D.; Utz W.J.; Parks P.J. Objectives: To determine whether the Vasclip implant procedure would (a) be equivalent to vasectomy in producing azoospermia, (b) produce greater patient satisfaction postoperatively, and (c) result in lower complication rates, postoperative pain, hematoma formation, spermatic granuloma, and surgical site infection when compared with historical controls. Methods: Sterilization and complications were studied in 124 consecutive patients. Results: Successful sterilization, defined by azoospermia at 10 to 14 months, was observed in 116 of 119 subjects. The effectiveness seemed to be equivalent to that of vasectomy. The incidence of postoperative pain and hematoma formation was similar to that with standard methods. The Vasclip procedure had similar infection rates and seemed to have lower rates of sperm granuloma when compared with vasectomy. In 3 subjects with persistent presence of sperm, histologic examination after traditional vasectomy indicated that misalignment of the device led to partial vas incision with recanalization. Patient acceptability was high: of the clinical study patients, 99% of survey respondents would recommend that other men considering a vasectomy have the Vasclip procedure. Conclusions: The Vasclip implant procedure represents a new, effective, office-based alternative to vasectomy. Physicians' benefits can include reduced procedural time and reduction of postprocedural complications. Potential patients' benefits include reduced risk of postoperative infection and sperm granuloma formation. Publication Type: Journal: Article Source: EMBASE 10

12 Percutaneous vasectomy: A simple modification eliminates the steep learning curve of no-scalpel vasectomy Journal of Urology, April 2003, vol./is. 169/4( ), (01 Apr 2003) Jones J.S. Purpose: We report a simplified method to avoid the most difficult step of no-scalpel vasectomy, while maintaining its minimally invasive advantages. Materials and Methods: Using the no-scalpel vasectomy instruments in percutaneous fashion we perform vasectomy in the office setting without fixation of the vas to skin using the ring clamp. The sharp no-scalpel hemostat punctures the skin. The vas is then grasped with the ringed instrument instead of piercing the vas and performing the supination maneuver, as described for no-scalpel vasectomy. Results: Percutaneous vasectomy was performed in 573 men by a single surgeon. In the 35 consecutive cases recently reviewed average operative time was 9.3 minutes with an additional 67 seconds added when a resident performed the procedure on 1 side in 15 cases. As determined by the knuckle of vas pulled through a puncture, average incisional length was 8.4 mm. Patients reported complete recovery in an average of 8.9 days. No major complications occurred. A single case of recanalization (0.17%) was successfully corrected by repeat percutaneous vasectomy. Conclusions: Percutaneous vasectomy is a minimally invasive option for permanent male sterilization that avoids the difficult aspects of no-scalpel vasectomy. Publication Type: Journal: Article Source: EMBASE 11