Open randomized clinical trial of laparoscopic versus open incisional hernia repair

Background  Incisional hernia is a common complication following abdominal surgery. Although the use of prosthetics has decreased recurrence rates, the standard open approach is still unsatisfactory. Laparoscopic techniques are an attempt to provide similar outcomes with the advantages of minimally invasive surgery. Methods  Open randomized controlled clinical trial with follow-up at 1, 2, 3, 7, and 15 days, and 1, 3, and 12 months from hernia repair. The study was carried out in the surgery departments of three general hospitals of the Valencia Health Agency. Objectives  To compare laparoscopic with anterior open repair using health-related quality of life outcomes as main endpoints. Results  Eighty-four patients with incisional hernia were randomly allocated to an open group (OG) (n = 39) or to a laparoscopic group (LG) (n = 45). Seventy-four patients completed 1-year follow up. Mean length of stay and time to oral intake were similar between groups. Operative time was 32 min longer in the LG (p < 0.001). Conversion rate was 11%. The local complication rate was superior in the LG (33.3% versus 5.2%) (p < 0.001). Recurrence rate at 1 year (7.9% versus 9.7%) was similar in the two groups. There were no significant differences in the pain scores or the EQ5D tariffs between the two groups during follow-up. Conclusions  Laparoscopic incisional hernia repair does not seem to be a better procedure than the open anterior technique in terms of operative time, hospitalization, complications, pain or quality of life.     

Cost effectiveness of laparoscopic versus mini-incision open donor nephrectomy: a randomized study

BACKGROUND: Cost-effectiveness remains an issue surrounding the introduction of laparoscopic donor nephrectomy (LDN). METHODS: In a randomized controlled trial the cost-effectiveness of LDN versus mini-incision open donor nephrectomy (ODN) was determined. Fifty donors were included in each group. All in-hospital costs were documented. Postoperatively, case record forms were sent to the donors during 1-year follow-up to record return-to-work and societal costs. To offset costs against quality of life, the Euroqol-5D questionnaire was administered preoperatively and 3, 7, 14, 28, 90, 180, and 365 days postoperatively. RESULTS: Mean total costs were euro6,090 (US$7,308) after LDN and euro4,818 ($5,782) after ODN (P<0.001). Disposables influenced the cost difference most. Mean productivity loss was 68 and 75 days after LDN and ODN respectively, corresponding to euro783 ($940) gained per donor after LDN. The main gain in quality of life in the LDN group was realized within 4 weeks postoperatively. LDN resulted in a mean gain of 0.03 quality-adjusted life years at mean costs of euro1,271 ($1,525) and euro488 ($586) from a healthcare perspective and a societal perspective, respectively. This implies that one additional Quality-Adjusted Life Year after LDN costs about euro16,000 ($19,200) from a societal point of view and about euro41,000 ($49,200) from a health-care perspective. Activities other than work were resumed significantly earlier after LDN (66 vs. 91 days, P=0.01). CONCLUSION: In addition to a clinically relevant donor-experienced benefit from LDN, this technique appeared, given a societal perspective, a cost-efficient procedure mainly due to less productivity losses.     

Recurrence and complications after laparoscopic versus open inguinal hernia repair: results of a prospective randomized multicenter trial

BACKGROUND: The aim of this prospective randomized multicenter trial was to evaluate the recurrence rates and complications of open versus laparoscopic repairs of inguinal hernias. METHODS: Patients with primary unilateral inguinal hernias were randomized to Shouldice repair, Bassini operation, tension-free hernioplasty (Lichtenstein repair), laparoscopic transabdominal extraperitoneal hernioplasty (TEP), or laparoscopic transabdominal preperitoneal hernioplasty (TAPP). The primary outcome parameter was the rate of recurrence at 3 years. The secondary outcome was the rate of intraoperative, perioperative, and long-term complications. Follow-up comprised of clinical examination after 1, 2, and 3 years. RESULTS: Three hundred and sixty-five patients were randomly assigned to one of the five procedures. The intention-to-treat analysis showed that the cumulative 3-year recurrence rate was 3.4% in the Bassini group, 4.7% in the Shouldice group, 0% in the Lichtenstein group, 4.7% in the TAPP group, and 5.9% in the TEP group (p = 0.48). Comparing open (Bassini, Shouldice, Lichtenstein) versus laparoscopic (TAPP, TEP) techniques (p = 0.29) and comparing the use of mesh prostheses (Lichtenstein, TAPP, TEP) versus suturing techniques (Bassini, Shouldice) (p = 0.74) showed no significance in the rate of recurrence. The rates of intraoperative (p = 0.15), perioperative (p = 0.09), and long-term complications (p = 0.13) were without significance between the five groups. Comparing mesh techniques (Lichtenstein, TAPP, TEP) versus suturing techniques (Bassini, Shouldice) showed no significance in the rate of complications. The per-protocol analysis for the comparison of mesh (Lichtenstein, TAPP, TEP) versus suturing (Bassini, Shouldice) techniques revealed that recurrences (p = 0.74), intraoperative (p = 0.64), perioperative (p = 0.27), and long-term complications (p = 0.91) were evenly distributed. CONCLUSIONS: In this multicenter study, no significant difference in the recurrence rate and complications between laparoscopic and open methods of hernia repair was revealed.     

Randomized clinical trial of laparoscopic versus open inguinal hernia repair

BACKGROUND: Several studies have suggested that better results are obtained after laparoscopic repair of inguinal hernia than after conventional operation. This is most obvious for bilateral and recurrent hernias but less accepted for primary unilateral hernias. METHODS: This was a randomized clinical trial comparing transabdominal preperitoneal laparoscopic repair with the Shouldice technique in patients with primary unilateral hernia. Some 138 patients were randomized to laparoscopic hernia repair and 130 to open surgical repair. RESULTS: The complication rates in the two groups were similar. In the laparoscopic group the patients returned to work more rapidly with a median time of 13 versus 18 days (P < 0.005) and had a shorter period of analgesia intake with a median time of 2.1 versus 2.7 days (P < 0.02). The follow-up was 97.8 per cent complete. At a median of 12 months, four recurrences (2.9 per cent) were detected in the laparoscopic group and three (2.3 per cent) in the open group. CONCLUSION: This study shows that in patients with a primary unilateral hernia laparoscopic repair results in less postoperative pain and a quicker recovery than open repair.     

Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: a prospective randomized controlled trial

BACKGROUND: This study was designed to compare an open tension-free technique (Lichtenstein repair) with a laparoscopic totally extraperitoneal hernia repair (TEP). METHODS: One hundred sixty-eight men aged 30 to 65 years with primary or recurrent inguinal hernia were randomized to TEP or open mesh technique in the manner of Lichtenstein. Follow-up was after 1 and 6 weeks, and 1 year. RESULTS: Eighty-one patients were randomized to TEP, and 87 to open repair. For 1 patient in each group, the operation was converted to a different type of repair. No difference was seen in overall complications between the 2 groups. However, 1 patient in the TEP group underwent operation for small bowel obstruction after surgery. A higher frequency of postoperative hematomas was seen in the open group (P <.05). Patients in the TEP group consumed less analgesic after surgery (P <.001), returned to work earlier (P <.01), and had a shorter time to full recovery (P <.01). Two recurrences occurred in the TEP group 1 year after surgery. CONCLUSION: The TEP technique was associated with less postoperative pain, a shorter time to full recovery, and an earlier return to work compared with the open tension-free repair. No difference was seen in overall complications. However, 2 recurrences did occur after 1 year in the TEP group.     

Mesh shrinkage and pain in laparoscopic ventral hernia repair: a randomized clinical trial comparing suture versus tack mesh fixation

Background  

Mesh fixation during laparoscopic ventral hernia repair can be performed using transfascial sutures or metal tacks. The aim of the present study is to compare mesh shrinkage and pain between two different techniques of mesh fixation in a prospective randomized trial.     

Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair

BACKGROUND: Laparoscopic herniorrhaphy has emerged as a recognized operative method for inguinal hernia repair. This study compared the short-term results of two tension-free methods of repair: totally extraperitoneal (TEP) laparoscopic patch repair and the open Lichtenstein mesh technique. METHODS: A total of 1513 men from 11 hospitals who presented with a primary unilateral inguinal hernia were randomized to one of the two methods. Operating time, short-term complications, reoperations, postoperative pain, consumption of analgesics, sick leave and time to resumption of normal physical activities were recorded. RESULTS: Some 1371 of the 1513 men underwent surgery, 665 in the TEP group and 706 in the Lichtenstein group. The median duration of operation was 55 min for both procedures and 91.0 percent of the patients in both groups were discharged on the day of operation. Patients in the TEP group experienced less postoperative pain (P<0.001), consumed fewer analgesics (P<0.001), had a shorter period of sick leave (7 versus 12 days; P<0.001) and a shorter time to resumption of normal physical activity (20 versus 31 days; P<0.001). CONCLUSION: The TEP technique took no longer to perform, and was associated with less postoperative pain, a shorter period of sick leave and a faster recovery, compared with open Lichtenstein hernia repair.     

Laparoscopic versus open ventral hernia repair: a randomized controlled trial

Laparoscopic and open techniques are both recognized treatment options for ventral hernias. We conducted a prospective randomized trial of both methods, to assess hernia recurrence, postoperative recovery and complications. Fifty-eight patients with ventral hernias were enrolled into the trial between August 2003 and December 2005. Of these, 31 underwent laparoscopic repair and 27 underwent open repair. Clinical parameters were documented on all patients during a median follow-up period of 27.5 months. The demographics of the two groups were similar. There was one recurrence in each of the laparoscopic and open groups. There was an equivalent rate of operative time, length of stay, postoperative pain scores, return to normal activities, wound infection and seroma formation between the two groups. Laparoscopic and open ventral hernia repair are comparable and offer low recurrence rates.     

Single-blind randomized clinical trial of laparoscopic versus open appendicectomy in children

BACKGROUND: Appendicectomy is the most common emergency surgical operation in children. The aim of this study was to compare recovery after appendicectomy using either a laparoscopic or an open technique in children. METHODS: Sixty-one children aged 4-15 years undergoing appendicectomy for suspected uncomplicated appendicitis were studied. The study was prospective, randomized and single-blinded, with parallel groups. Standardized anaesthetic technique and pain management were used. The study endpoints were postoperative pain, need for rescue analgesia, and length of hospital stay. RESULTS: Children had significantly less pain after laparoscopic compared with open appendicectomy 8 h after operation and on the first and second postoperative mornings (P < 0.05). Laparoscopic appendicectomy resulted in a reduced requirement for rescue analgesia with oxycodone in hospital: mean(s.d.) 3.6(2.5) versus 5.8(3.3) doses (mean difference 2.2 doses, 95 per cent confidence interval (c.i.) 0.6--3.8 doses); P = 0.01. The mean(s.d.) length of hospital stay was significantly shorter in the laparoscopic group: 1.9(0.7) versus 2.6(0.9) days (mean difference 0.7 days, 95 per cent c.i. 0.3--1.1 days); P = 0.001. Three children who had open appendicectomy developed a wound infection. CONCLUSION: Laparoscopic appendicectomy is associated with less postoperative pain and a shorter hospital stay than open appendicectomy in children undergoing surgery for uncomplicated appendicitis.     

Laparoendoscopic single-site versus conventional laparoscopic total extraperitoneal hernia repair: a prospective randomized clinical trial

Background

This study aimed to compare laparoendoscopic single-site (LESS) total extraperitoneal (TEP) repair with conventional laparoscopic TEP repair for the treatment of inguinal hernias. To date, no other studies have compared the LESS and conventional laparoscopic TEP approaches for the treatment of inguinal hernia in a prospective randomized study setting.

Methods

For this study, 100 patients undergoing inguinal hernia repair were prospectively randomized into either the LESS TEP group or the conventional laparoscopic TEP group. Pre-, intra-, and postoperative factors were recorded. The primary end point was postoperative pain. The patients were interviewed at outpatient clinics at 1 week, 3 months, and 6 months postoperatively.

Results

The demographic data were comparable between the two groups. The median operative time was longer in the LESS TEP group (63.5 min) than in the conventional TEP group (50.5 min) (p = 0.001). No conversion was performed in either group. The mean pain score 2 h postoperatively during rest was significantly higher in the conventional TEP group than in the LESS TEP group (3.9 vs. 2.6; p = 0.02). The postoperative results were comparable between the groups in terms of analgesic requirements, systemic stress responses, complications, and postoperative convalescence.

Conclusions

The LESS TEP technique is associated with a longer operative time but offers the minor benefit of a reduction in immediate postoperative pain.     

Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair

BACKGROUND: Two of the most commonly used open prosthetic tension-free techniques for inguinal hernia repair are Lichtenstein's operation and the mesh plug repair. The technique of choice remains a subject of ongoing debate. The objective of the present investigation was to compare the two surgical procedures with respect to associated morbidity and recurrence rates. METHODS: Five hundred and ninety-five patients with 700 primary or recurrent inguinal hernias were randomized to undergo either Lichtenstein's operation or mesh plug repair. The primary endpoint of the investigation was the recurrence rate 1 year after surgery. Secondary endpoints were perioperative complications and reoperation rates. RESULTS: At 12-month follow-up, 597 hernia repairs (85.3 per cent) were evaluated. There were no significant differences regarding recurrence rates and perioperative complications. However, there was a significant difference in the overall reoperation rate between the two treatment groups, with 13 reoperations (4.2 per cent) in the Lichtenstein group and four (1.4 per cent) in the mesh plug group (P = 0.047). CONCLUSION: Lichtenstein's operation and the mesh plug repair are comparable with respect to perioperative complications and recurrence rates.     

Hand-assisted laparoscopic versus open right colectomy: a randomized controlled trial

OBJECTIVE: Laparoscopic colectomy has been proved to be both technically and oncologically feasible. However, the approach has been criticized for its procedural complexity and long operative time as a result of the loss of tactile feedback and absence of depth perception. The advent of hand-access devices offered a potential solution to these problems. This randomized controlled trial aims to compare hand-assisted laparoscopic colectomy (HALC) with open colectomy (OC) in the management of right-sided colonic cancer. METHODS: Adult patients with nonmetastatic carcinoma of cancer or ascending colon were recruited. Patients were excluded if they presented with surgical emergencies, had synchronous tumors on work-up, or when the tumor was larger than 6.5 cm in any dimension or preoperative imaging. Recruited patients were randomized to undergo either HALC or OC by the same surgical team. Outcome measures included operative time, blood loss, postoperative pain score and analgesic requirement, length of hospital stay, postoperative complications, as well as disease recurrence and patient survival. RESULTS: Eighty-one patients (HALC = 41, OC = 40) were successfully recruited. The 2 groups were matched for age, gender distribution, body mass index, and comorbidities. No significant difference was observed between the 2 groups in the distribution of tumors and the final histopathological staging. HALC took significantly longer than OC (110 min vs. 97.5 minutes, P = 0.003) but resulted in significantly less blood loss (35 mL vs. 50 mL, P = 0.005). Patients after HALC experienced significantly less pain, required significantly less parenteral and enteral analgesia, recovered faster, and was associated with a shorter length of stay (7 days vs. 9 days, P = 0.004). With median follow-up of 28 to 30 months, no difference was observed in terms of disease recurrence, and the 5-year survival rates remained similar (83% vs. 74%, P = 0.90). CONCLUSION: HALC retained the same short-term benefits of the pure laparoscopic approach. The technique is associated with a slightly increased but acceptable operative time. Aside as a useful adjunct in complex laparoscopic procedures, the hand-assisted laparoscopic technique is also a useful, if not more effective, alternative for patients with right-sided colonic cancer.     

Long-term follow-up of a randomized clinical trial of non-mesh versus mesh repair of primary inguinal hernia

BACKGROUND: Prospective studies and meta-analyses have indicated that non-mesh repair is inferior to mesh repair based on recurrence rates in inguinal hernia. The only reliable way to evaluate recurrence rates after hernia surgery is by long-term follow-up. METHODS: Between September 1993 and January 1996, a multicentre clinical trial was performed, in which 300 patients with unilateral primary inguinal hernia were randomized to non-mesh or mesh repair. Long-term follow-up was carried out from June 2005 to January 2006. RESULTS: Median follow-up was 128 months for non-mesh and 129 months for mesh repair. The 10-year cumulative hernia recurrence rates were 17 and 1 per cent respectively (P = 0.005). Half of the recurrences developed after 3 years' follow-up. There was no significant correlation between hernia recurrence and age, level of expertise of the surgeon, contralateral hernia, obesity, history of pulmonary disease, constipation or prostate disease. CONCLUSION: After 10 years mesh repair is still superior to non-mesh hernia repair. Recurrence rates may be underestimated as recurrences continue to develop for up to 10 years after surgery.     

Randomized clinical trial comparing laparoscopic totally extraperitoneal approach with open mesh repair in inguinal hernia

The aim of this study was to compare laparoscopic totally extraperitoneal approach (TEP) repair with tension-free open mesh repair in inguinal hernia. One hundred thirty-four patients were allocated randomly to undergo TEP repair (n = 67) or open mesh repair (n = 67). Operative and postoperative outcomes were determined. The mean of operating time (49.67 +/- 14.11 vs. 56.64 +/- 12.32; P = 0.001), visual analog scale score (2.73 +/- 1.69 vs. 4.61 +/- 1.77; P = 0.001), hospital stay (1.8 +/- 0.7 vs. 2.7 +/- 1.6; P = 0.001), and duration of recovery (10.8 +/- 7.4 vs. 15.2 +/- 8.5; P = 0.001) was significantly less for TEP repair when compared with open mesh repair. The incidence of complications (13.4% vs. 16.4%; P = 0.631) and recurrence (2.9% vs. 5.9%; P = 0.407) was approximately equal in each group. Our results showed that laparoscopic TEP repair is superior to open mesh repair.     

国产可吸收钉固定器与进口同类产品在腹腔镜腹壁疝修补术中的临床对比研究

目的比较一种国产可吸收钉固定器和临床上已成熟应用的进口同类产品在腹腔镜腹壁疝修补术中的应用情况,以系统评价国产可吸收钉固定器的安全性及有效性。 方法2014年7月至2015年7月,首都医科大学附属北京朝阳医院采用前瞻性、单盲（对受试者）、随机对照研究,将符合病例要求的30例疝病患者随机分为试验组和对照组。其中试验组15例,应用国产可吸收钉固定器。对照组15例,应用进口同类产品,同期行腹腔镜腹壁疝修补术。对2组手术前后临床参数、术后即刻固定效果、器械的流畅性和准确性等操控性能、术后并发症情况等方面进行统计学分析,并对术后不良事件情况进行记录与评价。 结果试验组与对照组在基线人口统计学、生命体征、生化指标、疝类型、疝缺损大小、手术方式、固定方式等方面比较,差异无统计学意义（P>0.05）。试验组术后即刻固定效果1例为差。器械流畅性和准确性方面,试验组和对照组比较,差异无统计学意义（P>0.05）。术后随访6个月,2组均未见复发,其他术后并发症等安全性指标比较,差异无统计学意义（P>0.05）。试验期间共发生6例不良事件,2例严重不良事件,经判断与试验产品的相关度均为"可能无关"。 结论该国产可吸收钉固定器安全、可靠,在综合临床效果上与已被批准上市的进口同类产品相当,具有临床应用价值。